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trimethoprim, sulfamethoxazole drug combination

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Description

Trimethoprim, Sulfamethoxazole Drug Combination: A drug combination with broad-spectrum antibacterial activity against both gram-positive and gram-negative organisms. It is effective in the treatment of many infections, including PNEUMOCYSTIS PNEUMONIA in AIDS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

co-trimoxazole : A two-component mixture comprising trimethoprim and sulfamethoxazole. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID358641
CHEMBL ID58061
CHEBI ID3770
SCHEMBL ID870329
MeSH IDM0024001

Synonyms (205)

Synonym
benzenesulfonamide, 4-a)mino-n-(5-methyl-3-isoxazolyl)-, mixt. with 5-((3,4,5-trimethoxyphenyl)methyl-2,4-pyrimidinediamine
trimethoprim, sulfamethoxazole drug combination
8064-90-2
nsc-618652
benzenesulfonamide, mixt. with 5-[(3,4,5-trimethoxyphenyl)methyl]-2,4- pyrimidinediamine
co-trimoxazole
esteprim
trimethoprim and sulfamethoxazole
cotrim-puren
trimethoprim-sulfamethoxazole combination
trimethoprim and sulphamethoxazole
benzenesulfonamide, 4-amino-n-(5-methyl-3-isoxazolyl)-, mixt. with 5-((3,4,5-trimethoxyphenyl)methyl)-2,4-pyrimidinediamine
abacin
kemoprim
biseptol
gantaprin
bactiver
trigonyl
supracombin
trimexazol
primazole
microtrim
mikrosid
cotriver
sigaprim
teleprim
trimetho comp
omsat
bibacrim
strepto-plus
baktar
cotrim_basf
centrin
insozalin
sulfamethoxazole-trimethoprim
chemitrim
pyrimidine, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)- and n'-(5-methyl-3-isoxazolyl)sulfanilamide
oxaprim
uroplus
sulfa-tyl
suprim
chemotrim
bactoreduct
bactrizol
co-trimaxazol
bactromin
eslectin
ciplin
trimexole-f
teleprin
cotrimoxazole
thiocuran
agoprim
maxtrim
imexim
cotrimoxazol al
jenamoxazol
abactrim
bacton
pantoprim
fectrim
sulfotrimin
dibaprim
sulprim
trimethoprim/sulfamethoxazole
laratrim
duon
drylin
sigaprin
eltrianyl
nsc 618652
bactropin
groprim
escoprim
cotrimhexal
trimetoger
kepinol forte
cotrimox-wolff
trifen
cotrim-hefa
eusaprim
trimezole
momentol
trimosulfa
trimforte
alfatrim
co-trim-tablinen
septrim
kepinol
oecotrim
microtrim forte
cotribene
servitrim
sumetrolim
cotrim holsen
gantaprim
bactrim forte
tribakin
tms 480
aposulfatrim
cotrim-radiopharm
cotrimoxazol
trimethoprim-sulfamethoxazole
linaris
cotrimoxazol-cophar
berlocid
trimethoprimsulfa
hsdb 6780
duratrimet
sulfotrim
cotrim eu rho
helveprim
cotrimstada
nopil
tacumil
trimesulf
bacteral
comox
bactilen
centran
baktrisid-ds
oriprim
trimedin
bacterial forte
a 033
septrin
septra
sulfatrim
tmp-smx
co-trimazole
sxt
cotrim
50808-41-8
trimethoprim & sulfamethoxazole
benzenesulfonamide, 4-amino-n-(5-methyl-3-isoxazolyl)- & 5-((3,4,5-trimethoxyphenyl)methyl)-2,4-pyrimidinediamine
4-amino-n-(5-methylisoxazol-3-yl)benzenesulfonamide; 5-[(3,4,5-trimethoxyphenyl)methyl]pyrimidine-2,4-diamine
tmp & smx
gantrim
nsc618652
co-trimoxazole (ban)
septra (tn)
bactrim (tn)
sulfamethoxazole and trimethoprim
D00285
sulfamethoprim-ds
sulfamethoxazole & trimethoprim
sulfatrim-ds
sulfatrim-ss
sulfamethoxazole; trimethoprim
sulfamethoxazole and trimethoprim double strength
sulfamethoxazole and trimethoprim single strength
uroplus ds
bactrim pediatric
sulfatrim pediatric
sulmeprim pediatric
septra grape
uroplus ss
bactrim ds
septra ds
CHEMBL58061
sulfameth/trimeth
sulfameth/tmp
sulfamethoxazole-trimeth
tmp / smx
sulfamethoxazole trimethoprim
tmp/smx
cotrim.l.u.t.
smx-tmp
cotrim d.s.
smx/tmp
sulfamethoxazole / tmp
smx / tmp
sulfamethoxazole / trimethoprim
EPITOPE ID:141805
chebi:3770
benzenesulfonamide, 4-amino-n-(5-methyl-3-isoxazolyl)-, mixt. with 5-[(3,4,5-trimethoxyphenyl)methyl]-2,4-pyrimidinediamine
SCHEMBL870329
WZRJTRPJURQBRM-UHFFFAOYSA-N
AKOS030548395
4-amino-n-(5-methylisoxazol-3-yl)benzenesulfonamide compound with 5-(3,4,5-trimethoxybenzyl)pyrimidine-2,4-diamine (1:1)
Q898623
DTXSID0032233 ,
sulfamethoxazole/trimethoprim
4-amino-n-(5-methyl-1,2-oxazol-3-yl)benzenesulfonamide;5-[(3,4,5-trimethoxyphenyl)methyl]pyrimidine-2,4-diamine
CS-0182655
cotrimoxazole (trimethoprim/sulfamethoxazole 1:5)
HY-141619
trimethoprim / sulfamethoxazole
sulfamethoxazole/tmp
sulfameth/trimeth-ds
sulfamethoxazole and trimethoprim ds
sulfamethox-tmp ds
dtxcid301474601
sulfamethoxazole and trimethoprimdouble strength
trimethoprim;sulfamethoxazole
sulfamethoxazole;trimethoprim
4-amino-n-(5-methyl-1,2-oxazol-3-yl)benzenesulfonamide-5-(3,4,5-trimethoxybenzyl)pyrimidine-2,4-diamine (1:1)
sulfamethoxazole and trimethoprimds
sulfamethoxazole, trimethoprim
pyrimidine, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)-and n'-(5-methyl-3-isoxazolyl)sulfanilamide
sulfamethoxazole-trimethoprim mixture
sulfamethoxazol/trimetoprim
cotrimoxazole (trimethoprim/sulfamethoxazole 1:19)
HY-141619A
CS-0885981

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Adverse events probably related to treatment occurred in 6% of those treated with lomefloxacin and in 7% of patients treated with TMP/SMX."( Comparison of the safety and efficacy of lomefloxacin and trimethoprim/sulfamethoxazole in the treatment of uncomplicated urinary tract infections: results from a multicenter study.
Aguirre-Avalos, G; Andrade-Villanueva, J; Flores-Gaxiola, A; Lopez-Guillen, P; Morfin-Otero, R; Rodriguez-Noriega, E, 1992
)
0.28
"A case of adverse side effects of co-trimoxazole (Biseptol) was observed, with predominance of neurological changes in the clinical picture."( [A case of side effect of Biseptol].
Kepa, L, 1992
)
0.28
"Questions have been raised regarding the safety of trimethoprim-sulfamethoxazole (TMP-SMZ) in organ transplantation, particularly adverse interactions with azathioprine and cyclosporine."( A prospective, randomized, double-blind study of trimethoprim-sulfamethoxazole for prophylaxis of infection in renal transplantation. Side effects of trimethoprim-sulfamethoxazole, interaction with cyclosporine.
Belzer, FO; Fox, BC; Kuntz, J; Maki, DG; Sollinger, HW, 1992
)
0.28
" A total of 46% of patients developed an adverse reaction, that was considered severe in 24."( [Adverse effects of cotrimoxazole in Spanish patients with AIDS and pneumonia caused by Pneumocystis carinii].
Cifuentes, N; Lucero, MI; Pérez-Cortés, S; Pérez-Pérez, M; Torres, M; Vergara de Campos, A,
)
0.13
" A treatment course of ofloxacin, once-a-day for three days, was as safe and effective as a standard course of TMP/SMX, twice a day for seven days."( Randomized study to evaluate efficacy and safety of ofloxacin vs. trimethoprim and sulfamethoxazole in treatment of uncomplicated urinary tract infection.
Basista, MP, 1991
)
0.28
" This precludes drawing conclusions about relative risks of side effects from the current system of notifications of adverse drug effects."( Adverse effects of antibiotics in a general practice. The relative risk of co-trimoxazole.
Bridges-Webb, C; Britt, H, 1990
)
0.28
" We conclude (1) that extending high dose cotrimoxazole therapy beyond 2 weeks is usually unnecessary, provided that reduced dose maintenance therapy is given directly, and (2) that dose reduction on appearance of toxicity signs during the second week of treatment is safe and allows two-thirds of patients to be maintained on cotrimoxazole with satisfactory results."( Can the course of high dose cotrimoxazole for Pneumocystis carinii pneumonia in AIDS be shorter? A possible solution to the problem of cotrimoxazole toxicity.
Danner, SA; Eeftinck Schattenkerk, JK; Lange, JM; van Steenwijk, RP, 1990
)
0.28
" There were 39 toxic reactions, 15 of them serious: leukopenia (n = 23), abnormal liver functions (n = 14), skin changes (n = 12), gastrointestinal complaints (n = 10) and thrombocytopenia (n = 9)."( [Side effects of trimethoprim-sulfamethoxazole in patients with AIDS].
de Matos-Marques, B; Pohle, HD; Ruf, B; Sixt, C; Weinke, T, 1988
)
0.27
"During the decade 1968-1978 the Danish Board of Adverse Reactions to Drugs received 572 (6% of the total number) reports on hepatotoxicity."( Drug-induced liver disease in Denmark. An analysis of 572 cases of hepatotoxicity reported to the Danish Board of Adverse Reactions to Drugs.
Andreasen, PB; Døssing, M, 1982
)
0.26
"Trimethoprim-sulphamethoxazole (TMP-SMZ) is considered a safe drug for treatment of infectious bacterial diseases in children."( Fulminant hepatic failure in a child as a potential adverse effect of trimethoprim-sulphamethoxazole.
Deutsch, J; Fend, F; Margreiter, R; Meister, B; Ofner, D; Simma, B; Sperl, W; Vogel, W, 1995
)
0.29
"Atovaquone was compared to trimethoprim-sulfamethoxazole (TMP-SMZ) for the relationship of time receiving therapy, plasma drug concentrations, and incidence of adverse reactions in patients with AIDS-associated Pneumocystis carinii pneumonia."( Adverse events associated with trimethoprim-sulfamethoxazole and atovaquone during the treatment of AIDS-related Pneumocystis carinii pneumonia.
Hughes, WT; LaFon, SW; Masur, H; Scott, JD, 1995
)
0.29
" The treatment groups did not differ significantly with respect to changes in CD4 counts or p24 antigen levels or with respect to clinical adverse experiences or laboratory abnormalities."( Safety and efficacy of thymopentin in zidovudine (AZT)-treated asymptomatic HIV-infected subjects with 200-500 CD4 cells/mm3: a double-blind placebo-controlled trial.
Beall, G; Blick, G; Calabrese, LH; Conant, MA; Fisher, A; Galpin, JE; Goldstein, G; Grossman, HA; Hirsch, RL; Stampone, P, 1995
)
0.29
" One patient developed transient dyspnoea following a dose of SMX, but no other serious adverse drug reaction occurred."( Efficacy and safety of rechallenge with low-dose trimethoprim-sulphamethoxazole in previously hypersensitive HIV-infected patients.
Carr, A; Cooper, DA; Penny, R, 1993
)
0.29
"Rechallenge with TMP-SMX appears safe in HIV-infected patients with a history of non-life-threatening hypersensitivity and is most likely to be successful in patients with a low CD4+ lymphocyte count."( Efficacy and safety of rechallenge with low-dose trimethoprim-sulphamethoxazole in previously hypersensitive HIV-infected patients.
Carr, A; Cooper, DA; Penny, R, 1993
)
0.29
" For dapsone, among 100 patients given 100 mg daily instead of twice a week for 1 year (primary prophylaxis), seven fewer patients would develop P carinii pneumonia, but 17 more would have significant toxic reactions."( A meta-analysis of the relative efficacy and toxicity of Pneumocystis carinii prophylactic regimens.
Cappelleri, JC; Ioannidis, JP; Lau, J; Sacks, HS; Skolnik, PR, 1996
)
0.29
" Low doses of dapsone reduce toxic effects, but at the expense of some loss of efficacy."( A meta-analysis of the relative efficacy and toxicity of Pneumocystis carinii prophylactic regimens.
Cappelleri, JC; Ioannidis, JP; Lau, J; Sacks, HS; Skolnik, PR, 1996
)
0.29
"The overall incidence of adverse events (AE) in our study cohort was 39%."( Safety of dapsone as Pneumocystis carinii pneumonia prophylaxis in human immunodeficiency virus-infected patients with allergy to trimethoprim/sulfamethoxazole.
Beumont, MG; Graziani, A; MacGregor, RR; Ubel, PA, 1996
)
0.29
"Drug therapies for patients with human immunodeficiency virus (HIV) infection are associated with adverse events that can potentially limit their effectiveness."( Adverse events from drug therapy for human immunodeficiency virus disease.
Chaisson, RE; Fortgang, I; Keruly, J; Moore, RD, 1996
)
0.29
"We calculated specific and overall adverse event rates from use of zidovudine, didanosine, zalcitabine, cotrimoxazole, and dapsone in an observational urban cohort of 1,450 HIV-infected patients with a CD4+ count of 500 cells/mm3 or less."( Adverse events from drug therapy for human immunodeficiency virus disease.
Chaisson, RE; Fortgang, I; Keruly, J; Moore, RD, 1996
)
0.29
"Overall adverse event rates in order of incidence were dapsone, 16."( Adverse events from drug therapy for human immunodeficiency virus disease.
Chaisson, RE; Fortgang, I; Keruly, J; Moore, RD, 1996
)
0.29
" Adverse event rates increase progressively with decline in CD4+ count."( Adverse events from drug therapy for human immunodeficiency virus disease.
Chaisson, RE; Fortgang, I; Keruly, J; Moore, RD, 1996
)
0.29
" None of the 16 patients treated with atovaquone experienced treatment-associated adverse effects."( A prospective randomized trial comparing the toxicity and safety of atovaquone with trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia prophylaxis following autologous peripheral blood stem cell transplantation.
Colby, C; Finkelstein, D; Fishman, J; McAfee, S; Sackstein, R; Spitzer, T, 1999
)
0.3
"To determine whether foals with pneumonia that were treated with erythromycin, alone or in combination with rifampin or gentamicin, had a higher risk of developing adverse effects, compared with foals treated with trimethoprim-sulfamethoxazole (TMS), penicillin G procaine (PGP), or a combination of TMS and PGP (control foals)."( Risk of adverse effects in pneumonic foals treated with erythromycin versus other antibiotics: 143 cases (1986-1996).
Gardner, IA; Stratton-Phelps, M; Wilson, WD, 2000
)
0.31
" Relative risk (RR) and attributable risk (AR) were calculated to compare risk of adverse reactions between foals treated with erythromycin and control foals."( Risk of adverse effects in pneumonic foals treated with erythromycin versus other antibiotics: 143 cases (1986-1996).
Gardner, IA; Stratton-Phelps, M; Wilson, WD, 2000
)
0.31
"Trimethoprim-sulfamethoxazole (TMP/SMX) is recognized as the superior agent for Pneumocystis carinii pneumonia (PCP) prophylaxis but a high incidence of adverse drug reactions, which may be due to toxic drug metabolites, limits its use."( Reduced toxicity with gradual initiation of trimethoprim-sulfamethoxazole as primary prophylaxis for Pneumocystis carinii pneumonia: AIDS Clinical Trials Group 268.
Becker, S; Black, JR; Dohn, M; Finkelstein, D; Para, MF; Walawander, A, 2000
)
0.31
"Although potentially significant adverse reactions and drug interactions have been reported in association with erythromycin, oral tetracyclines, and trimethoprim-sulfamethoxazole, overall these agents are associated with excellent safety profiles, especially considering their widespread use over many years."( Systemic therapy for rosacea: focus on oral antibiotic therapy and safety.
Del Rosso, JQ, 2000
)
0.31
" Safety was assessed in the intent-to-treat population and the incidence of drug-related adverse events were significantly lower following CIP (17%) than following TMP/SMX (27%) (P= ."( Efficacy and safety of ciprofloxacin oral suspension versus trimethoprim-sulfamethoxazole oral suspension for treatment of older women with acute urinary tract infection.
Gomolin, IH; Haverstock, DC; Heyd, A; Reuning-Scherer, J; Siami, PF, 2001
)
0.31
" Furthermore, CIP suspension was associated with significantly lower rates of adverse events and premature discontinuations compared with TMP/SMX suspension."( Efficacy and safety of ciprofloxacin oral suspension versus trimethoprim-sulfamethoxazole oral suspension for treatment of older women with acute urinary tract infection.
Gomolin, IH; Haverstock, DC; Heyd, A; Reuning-Scherer, J; Siami, PF, 2001
)
0.31
" Phone call follow up in 25 patients disclosed that 15 patients continued to take celecoxib, while five patients did not take celecoxib following the oral challenge, and five discontinued celecoxib due to adverse effects, lack of drug efficacy or physician preference."( Safety of celecoxib in individuals allergic to sulfonamide: a pilot study.
Knowles, SR; Neuman, MG; Shapiro, LE; Shear, NH; Weber, E, 2003
)
0.32
"To evaluate QOL in women treated for acute cystitis, and describe the relationship between QOL, clinical outcome and adverse events of each of the interventions used in the study."( Women's quality of life is decreased by acute cystitis and antibiotic adverse effects associated with treatment.
Bergus, GR; Ernst, EJ; Ernst, ME; Hoehns, JD, 2005
)
0.33
"To evaluate QOL in women treated for acute cystitis, and describe the relationship between QOL, clinical outcome and adverse events of each of the interventions used in the study."( Women's quality of life is decreased by acute cystitis and antibiotic adverse effects associated with treatment.
Bergus, GR; Ernst, EJ; Ernst, ME; Hoehns, JD, 2005
)
0.33
" Clinical outcome was assessed by telephone interview on days 3, 7, 14 and 28 using a standardized questionnaire to assess resolution of symptoms, compliance with the prescribed regimen, and occurrence of adverse events."( Women's quality of life is decreased by acute cystitis and antibiotic adverse effects associated with treatment.
Bergus, GR; Ernst, EJ; Ernst, ME; Hoehns, JD, 2005
)
0.33
" While there was no difference in QOL by treatment assignment, patients experiencing an adverse event had lower QOL throughout the study period."( Women's quality of life is decreased by acute cystitis and antibiotic adverse effects associated with treatment.
Bergus, GR; Ernst, EJ; Ernst, ME; Hoehns, JD, 2005
)
0.33
" While QOL is improved by treatment, those reporting adverse events have lower overall QOL compared to those who do not experience adverse events."( Women's quality of life is decreased by acute cystitis and antibiotic adverse effects associated with treatment.
Bergus, GR; Ernst, EJ; Ernst, ME; Hoehns, JD, 2005
)
0.33
" We conducted a randomized controlled trial of a home-based, safe water intervention on the incidence and severity of diarrhea among persons with HIV living in rural Uganda."( Effect of home-based water chlorination and safe storage on diarrhea among persons with human immunodeficiency virus in Uganda.
Bunnell, R; Coutinho, A; Downing, R; Ekwaru, JP; Hughes, P; Kaharuza, F; Kigozi, A; Lule, JR; Malamba, S; Mermin, J; Nakanjako, D; Quick, R; Ransom, R; Wafula, W, 2005
)
0.33
" Given the substantial benefits of TMP-SMZ prophylaxis for HIV-infected women living in resource-limited settings, this review indicates that it is safe to abide by the WHO guidelines recommending daily TMP-SMZ prophylaxis for HIV-infected pregnant women."( Systematic review of the safety of trimethoprim-sulfamethoxazole for prophylaxis in HIV-infected pregnant women: implications for resource-limited settings.
Brooks, JT; Forna, F; Homsy, J; Kitabire, FN; McConnell, M; Mermin, J; Weidle, PJ,
)
0.13
"Although co-trimoxazole (trimethoprim-sulphamethoxazole) is an effective drug for prophylaxis against and treatment of Pneumocystis pneumonia, patients often experience adverse events with this combination, even at prophylactic doses."( Association of the diplotype configuration at the N-acetyltransferase 2 gene with adverse events with co-trimoxazole in Japanese patients with systemic lupus erythematosus.
Hara, M; Kamatani, N; Katsumata, Y; Kawaguchi, Y; Kawamoto, M; Mimori, A; Mitamura, T; Nakajima, A; Soejima, M; Sugiura, T; Takagi, K, 2007
)
0.34
" The pathophysiological mechanism involved may be either a direct toxic effect of trimethoprim or an immune-mediated reaction to sulfamethoxazole."( [Serious side effects of frequently used antibiotics in childhood: biliary sludge or stones induced by ceftriaxone and thrombocytopenia induced by co-trimoxazole].
Landstra, AM; Maseland, MH; van Setten, PA; Voeten, M, 2007
)
0.34
" Use of the Naranjo adverse drug reaction probability scale indicated a probable relationship (score of 5) between the patient's development of hepatotoxicity and the TMP-SMX therapy."( Trimethoprim-sulfamethoxazole-induced hepatotoxicity in a pediatric patient.
Bell, TL; Foster, JN; Townsend, ML, 2010
)
0.36
"Neurotoxicity is an unwanted acute side effect of aggressive chemotherapy."( Evidence for acute neurotoxicity after chemotherapy.
Cornelissen, J; Filippi, M; Giovannoni, G; Hintzen, R; Kappos, L; Kuhle, J; Lowenberg, B; Mondria, T; Petzold, A; Rocca, MA; te Boekhorst, P, 2010
)
0.36
"Trimethoprim-sulphamethoxazole (TMP-STX), an agent used for prophylaxis against pneumocystis pneumonia (PCP) in immunocompromised hosts, causes serious adverse effects (AEs) in some patients."( Positivity for anti-RNP antibody is a risk factor for adverse effects caused by trimethoprim-sulfamethoxazole, a prophylactic agent for P. jiroveci pneumonia, in patients with connective tissue diseases.
Arai, S; Fukuda, T; Kurasawa, K; Maezawa, R; Okada, H; Owada, T, 2013
)
0.39
"CTX is safe and efficacious against malaria."( Safety and efficacy of co-trimoxazole for treatment and prevention of Plasmodium falciparum malaria: a systematic review.
D'Alessandro, U; Manyando, C; Njunju, EM; Van Geertruyden, JP, 2013
)
0.39
"Antibiotic therapy during pregnancy may be beneficial and impacts positively on the reduction of adverse pregnancy outcomes."( Safety of daily co-trimoxazole in pregnancy in an area of changing malaria epidemiology: a phase 3b randomized controlled clinical trial.
Alessandro, UD; Champo, D; Chongwe, G; Claeys, Y; De Crop, M; Manyando, C; Mkandawire, R; Mulenga, M; Mwakazanga, D; Njunju, EM; Ravinetto, RM; Van Geertruyden, JP; van Overmeir, C, 2014
)
0.4
"Three databases and 1 conference abstract site were searched in duplicate up to October 31, 2013, for studies reporting adverse maternal and infant outcomes among women receiving cotrimoxazole during pregnancy."( Safety of cotrimoxazole in pregnancy: a systematic review and meta-analysis.
Abrams, EJ; Ford, N; Frigati, L; Jao, J; Mofenson, L; Shubber, Z, 2014
)
0.4
" The majority of adverse drug reactions were mild."( Safety of cotrimoxazole in pregnancy: a systematic review and meta-analysis.
Abrams, EJ; Ford, N; Frigati, L; Jao, J; Mofenson, L; Shubber, Z, 2014
)
0.4
" There were no differences between the study arms in the incidence of serious adverse events during the intervention and the incidence of malaria during the 1-y period after the intervention was stopped."( Protective efficacy and safety of three antimalarial regimens for the prevention of malaria in young Ugandan children: a randomized controlled trial.
Achan, J; Aweeka, FT; Bigira, V; Clark, TD; Dorsey, G; Havlir, DV; Huang, L; Kamya, MR; Kapisi, J; Kinara, S; Muhindo, MK; Mwangwa, F; Osterbauer, B; Rosenthal, PJ, 2014
)
0.4
" The study aims to assess whether the intervention regimen is not inferior, with respect to the incidence of pre-defined CTX-preventable events, to the control regimen and superior with respect to the incidence of haematological adverse events."( Safety of discontinuing cotrimoxazole prophylaxis among HIV infected adults on anti-retroviral therapy in Uganda (COSTOP trial): Design.
Abaasa, A; Anywaine, Z; Grosskurth, H; Kamali, A; Kasirye, R; Levin, J; Munderi, P; Nunn, A, 2015
)
0.42
" However, it is not commonly prescribed for patients with systemic lupus erythematous (SLE) due to the risk of adverse reactions (ADRs)."( Safety and efficacy of upfront graded administration of trimethoprim-sulfamethoxazole in systemic lupus erythematosus: A retrospective cohort study.
Deshpande, GA; Kawaguchi, Y; Kishimoto, M; Kobayashi, D; Matsui, K; Min, C; Okada, M; Rokutanda, R; Sassé, B; Suyama, Y; Takahashi, O, 2016
)
0.43
" There was also no association found between peak SMX levels and rates of adverse events."( Relationship of Sulfamethoxazole Therapeutic Drug Monitoring to Clinical Efficacy and Toxicity: A Retrospective Cohort Study.
Barreto, JN; Dao, BD; Dierkhising, RA; Ice, LL; Jannetto, PJ; Langman, LJ; Tosh, PK; Wolf, RC, 2016
)
0.43
" We evaluated the safety and tolerability of ATII-cell transplantation by assessing the emergent adverse side effects that appeared within 12 months."( Safety and Tolerability of Alveolar Type II Cell Transplantation in Idiopathic Pulmonary Fibrosis.
Arguis, P; Bayas, JM; Burgos, F; Closa, D; de la Bellacasa, JP; Fiblà, JJ; Gay-Jordi, G; Guillamat-Prats, R; Hernandez-Gonzalez, F; Marin, P; Martorell, J; Molins, L; Ramirez, J; Rodríguez-Villar, C; Rovira, I; Sánchez, M; Serrano-Mollar, A; Soy, D; Tetley, TD; Xaubet, A, 2016
)
0.43
"No significant adverse events were associated with the ATII-cell intratracheal transplantation."( Safety and Tolerability of Alveolar Type II Cell Transplantation in Idiopathic Pulmonary Fibrosis.
Arguis, P; Bayas, JM; Burgos, F; Closa, D; de la Bellacasa, JP; Fiblà, JJ; Gay-Jordi, G; Guillamat-Prats, R; Hernandez-Gonzalez, F; Marin, P; Martorell, J; Molins, L; Ramirez, J; Rodríguez-Villar, C; Rovira, I; Sánchez, M; Serrano-Mollar, A; Soy, D; Tetley, TD; Xaubet, A, 2016
)
0.43
"Our results support the hypothesis that ATII-cell intratracheal transplantation is safe and well tolerated in patients with IPF."( Safety and Tolerability of Alveolar Type II Cell Transplantation in Idiopathic Pulmonary Fibrosis.
Arguis, P; Bayas, JM; Burgos, F; Closa, D; de la Bellacasa, JP; Fiblà, JJ; Gay-Jordi, G; Guillamat-Prats, R; Hernandez-Gonzalez, F; Marin, P; Martorell, J; Molins, L; Ramirez, J; Rodríguez-Villar, C; Rovira, I; Sánchez, M; Serrano-Mollar, A; Soy, D; Tetley, TD; Xaubet, A, 2016
)
0.43
" Electronic health records were reviewed to determine baseline characteristics, rate of breakthrough PCP infection, characteristics of IV pentamidine use, and adverse events."( Safety and Effectiveness of Intravenous Pentamidine for Prophylaxis of Pneumocystis jirovecii Pneumonia in Pediatric Hematology/Oncology Patients.
Dubrovskaya, Y; Klejmont, LM; Lighter-Fisher, J; Papadopoulos, J; Scipione, MR; Solodokin, LJ, 2016
)
0.43
" Nineteen patients (16%) experienced adverse events and 5 of the 19 patients required discontinuation of IV pentamidine."( Safety and Effectiveness of Intravenous Pentamidine for Prophylaxis of Pneumocystis jirovecii Pneumonia in Pediatric Hematology/Oncology Patients.
Dubrovskaya, Y; Klejmont, LM; Lighter-Fisher, J; Papadopoulos, J; Scipione, MR; Solodokin, LJ, 2016
)
0.43
" The incidence of PJP infection in children with chronic glucocorticoid exposure is unknown, and PJP prophylaxis has been associated with adverse events."( Incidence of Pneumocystis jirovecii and Adverse Events Associated With Pneumocystis Prophylaxis in Children Receiving Glucocorticoids.
Basiaga, ML; Gerber, JS; Ogdie, A; Ross, ME, 2018
)
0.48
" In general, the intraventricular administration of cytotoxic antitumor drugs provides a high drug concentration in the cerebrospinal fluid with a reduced risk of systemic adverse reactions."( [A Survey of the Adverse Effects and Influence of Concomitant Drugs for Methotrexate Intrathecal Administration].
Imakyure, O; Kamimura, H; Matsuo, K; Takamatsu, Y; Uchiyama, M; Ueno, M, 2018
)
0.48
"Dapsone may be used for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in hematology patients receiving immunosuppressive therapy or after hematopoietic stem cell transplant (HSCT) in the setting of trimethoprim-sulfamethoxazole (TMP-SMX) adverse drug reaction (ADR) history."( Dapsone safety in hematology patients: Pathways to optimizing Pneumocystis jirovecii pneumonia prophylaxis in hematology malignancy and transplant recipients.
Pisasale, D; Trubiano, JA; Urbancic, KF; Wight, J, 2018
)
0.48
" There were significant dose-dependent increasing trends of severe adverse drug reactions (ADRs) for SMX/TMP that were graded as ≥3 according to the Common Terminology Criteria for Adverse Events."( Effectiveness and safety of lower dose sulfamethoxazole/trimethoprim therapy for Pneumocystis jirovecii pneumonia in patients with systemic rheumatic diseases: A retrospective multicenter study.
Iwagaitsu, S; Kazawa, N; Maeda, S; Miyamoto, T; Naniwa, T; Niimi, A; Ohmura, SI; Shichi, D; Tamechika, SY; Wada, JI, 2019
)
0.51
" Post-transplant management balances preventing PcP with managing TMP-SMX-related adverse effects."( Safety and efficacy of prophylaxis for Pneumocystis jirovecii pneumonia involving trimethoprim-sulfamethoxazole dose reduction in kidney transplantation.
Beckley, J; Gunasekaran, M; Huang, M; Mathur, M; Nash, MM; Prasad, GVR; Rapi, L; Zaltzman, JS, 2019
)
0.51
" Actual TMP-SMX dose and duration, adverse effects, number of dose reductions and reasons, and PcP events were captured."( Safety and efficacy of prophylaxis for Pneumocystis jirovecii pneumonia involving trimethoprim-sulfamethoxazole dose reduction in kidney transplantation.
Beckley, J; Gunasekaran, M; Huang, M; Mathur, M; Nash, MM; Prasad, GVR; Rapi, L; Zaltzman, JS, 2019
)
0.51
" To limit the need for TMP-SMX dose reduction due to adverse effects, a clinical trial comparing daily to thrice weekly single strength TMP-SMX in de-novo KTR is justified."( Safety and efficacy of prophylaxis for Pneumocystis jirovecii pneumonia involving trimethoprim-sulfamethoxazole dose reduction in kidney transplantation.
Beckley, J; Gunasekaran, M; Huang, M; Mathur, M; Nash, MM; Prasad, GVR; Rapi, L; Zaltzman, JS, 2019
)
0.51
" The adverse effects due to trimethoprim-sulfamethoxazole were more frequently observed in HIV-PCP (86."( Diagnosis and treatment of Pneumocystis jirovecii pneumonia in HIV-infected or non-HIV-infected patients-difficulties in diagnosis and adverse effects of trimethoprim-sulfamethoxazole.
Kato, H; Nakajima, H; Samukawa, S; Takahashi, H, 2019
)
0.51
" Though these drugs are generally well tolerated, they can result in potentially severe adverse effects."( Murphy's law in force: sequential adverse events encountered during the treatment of Pneumocystis pneumonia (cotrimoxazole-induced acute peripheral neuropathy and primaquine-induced methemoglobinemia).
Agarwal, R; Dhooria, S; Muthu, V; Prasad, KT; Saxena, P; Sehgal, IS, 2020
)
0.56
"For most antimicrobials reviewed, adverse maternal/fetal/neonatal outcomes were not observed consistently."( Safety of Antimicrobials During Pregnancy: A Systematic Review of Antimicrobials Considered for Treatment and Postexposure Prophylaxis of Plague.
Broussard, CS; Kim, HJ; Meaney-Delman, D; Nelson, CA; Parker, CM; Russell, Z; Smith, PW; Tran, EL; Yee, EL; Yu, PA; Yu, YC, 2020
)
0.56
" General and bortezomib-specific adverse events are monitored continuously."( Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.
Chung, HY; Geis, C; Günther, A; Lehmann, T; Leypoldt, F; Platzer, S; Prüss, H; Scherag, A; Wickel, J, 2020
)
0.56
"OST for properly selected patients with SAB could be a safe therapeutic option and can reduce their use of CIT and their hospital stay."( The benefits and safety of oral sequential antibiotic therapy in non-complicated and complicated Staphylococcus aureus bacteremia.
Álvarez-Fernández, M; Crespo, M; Diéguez, P; Lima, O; Longueira, R; Moreno-Flores, A; Pérez-Rodríguez, MT; Sousa, A; Suárez, M; Vasallo, FJ, 2021
)
0.62
" Although TMP/SMX is frequently used in dermatology for cases treated with corticosteroids and/or immunosuppressants, it is often difficult to continue the administration of TMP/SMX due to adverse events."( Adverse effects of trimethoprim-sulfamethoxazole for the prophylaxis of Pneumocystis pneumonia in dermatology.
Fujimoto, N; Kato, T; Kokubu, H; Nishikawa, J; Tanaka, T, 2021
)
0.62
"A study was conducted from March 2018 to October 2019; it included HIV-positive patients who presented an adverse skin reaction to TMP-SMX; fifteen of them received desensitization scheme 1, which lasted ten days, and five patients received scheme 2, which lasted six hours."( [The efficacy and safety of two schemes of desensitization to trimethoprim-sulfamethoxazole in HIV-positive patients].
Hernández-Morales, MR; Mancilla-Hernández, E,
)
0.13
"Both schemes of desensitization to TMP-SMX showed efficacy and safety in HIV-positive patients, who frequently present adverse reactions to these medications."( [The efficacy and safety of two schemes of desensitization to trimethoprim-sulfamethoxazole in HIV-positive patients].
Hernández-Morales, MR; Mancilla-Hernández, E,
)
0.13
" Our aim was to report adverse effects (AE) and outcome for patients presenting with cUTI and treated with these compounds."( Cotrimoxazole for community-acquired urinary tract infections leads to more adverse effects than fluoroquinolones.
Courjon, J; Curlier, E; Michelangeli, C; Roger, PM, 2021
)
0.62
" Adverse effects were associated with increased LHS compared to patients without AE: 11±6 vs."( Cotrimoxazole for community-acquired urinary tract infections leads to more adverse effects than fluoroquinolones.
Courjon, J; Curlier, E; Michelangeli, C; Roger, PM, 2021
)
0.62
" The endpoints were cumulative incidence of PCP and cumulative discontinuation rate of TMP-SMX due to adverse events."( Safety and efficacy evaluation of low-dose trimethoprim-sulfamethoxazole for prophylaxis of Pneumocystis pneumonia in HIV uninfected patients undergoing hemodialysis: a retrospective observational study.
Hashida, T; Ikesue, H; Muroi, N; Shimomura, Y; Yamashita, K; Yoshimoto, A, 2021
)
0.62
"None of the study patients developed PCP, and the cumulative discontinuation rate of TMP-SMX due to adverse events was significantly lower in the low-dose group compared to that in the standard-dose group (P = 0."( Safety and efficacy evaluation of low-dose trimethoprim-sulfamethoxazole for prophylaxis of Pneumocystis pneumonia in HIV uninfected patients undergoing hemodialysis: a retrospective observational study.
Hashida, T; Ikesue, H; Muroi, N; Shimomura, Y; Yamashita, K; Yoshimoto, A, 2021
)
0.62
" Several studies have suggested similar mortality outcomes and an improved adverse effect profile using a lower dose (<15 mg/kg/day) SMX-TMP regimen."( The effectiveness and safety of low dose trimethoprim-sulfamethoxazole for the treatment of pneumocystis pneumonia: A systematic review and meta-analysis.
Hejazi, AA; Timbrook, TT; Tritle, BJ, 2021
)
0.62
" Outcomes evaluated in our meta-analysis include survival and adverse reactions."( The effectiveness and safety of low dose trimethoprim-sulfamethoxazole for the treatment of pneumocystis pneumonia: A systematic review and meta-analysis.
Hejazi, AA; Timbrook, TT; Tritle, BJ, 2021
)
0.62
"After excluding studies that did not meet our inclusion criteria, four studies were analyzed for adverse reactions and three for mortality."( The effectiveness and safety of low dose trimethoprim-sulfamethoxazole for the treatment of pneumocystis pneumonia: A systematic review and meta-analysis.
Hejazi, AA; Timbrook, TT; Tritle, BJ, 2021
)
0.62
"This meta-analysis shows a significant decrease in adverse reactions and similar mortality rates with lower-dose SMX-TMP compared to conventional dosing."( The effectiveness and safety of low dose trimethoprim-sulfamethoxazole for the treatment of pneumocystis pneumonia: A systematic review and meta-analysis.
Hejazi, AA; Timbrook, TT; Tritle, BJ, 2021
)
0.62
" Regarding the adverse drug reactions (ADRs), quinolones did not bring higher risks, while the incidence of ADRs in the quinolone group was also even significantly lower (P < 0."( Efficacy and safety of quinolones vs. other antimicrobials for the treatment of uncomplicated urinary tract infections in adults: a systematic review and meta-analysis.
Cai, Y; Jia, Y; Wang, J; Yan, K; Zhu, M, 2022
)
0.72
" Data on IPT-related adverse events (AE) from sub-Saharan Africa are scarce."( Isoniazid preventive therapy-related adverse events among Malawian adults on antiretroviral therapy: A cohort study.
Buchwald, A; Divala, T; Laufer, MK; Laurens, MB; Mallewa, J; Mategula, D; Milanzi, E; Mungwira, R; Mwapasa, V; Nampota, N; Tsirizani-Galileya, L; Van Oosterhout, JJ, 2022
)
0.72
"To determine whether the therapeutic drug levels and adverse events (AEs) associated with renally cleared medications were higher in patients with cancer whose eGFRcys was more than 30% lower than their eGFRcr."( Medication-Related Adverse Events and Discordancies in Cystatin C-Based vs Serum Creatinine-Based Estimated Glomerular Filtration Rate in Patients With Cancer.
Gupta, S; Hanna, PE; Harden, D; Katz-Agranov, N; Leaf, DE; Moreno, D; Ouyang, T; Reynolds, KL; Seethapathy, H; Sise, ME; Strohbehn, IA; Wang, Q, 2023
)
0.91
"5 mEq/L), (3) baclofen toxic effect, and (4) supratherapeutic digoxin level (>2."( Medication-Related Adverse Events and Discordancies in Cystatin C-Based vs Serum Creatinine-Based Estimated Glomerular Filtration Rate in Patients With Cancer.
Gupta, S; Hanna, PE; Harden, D; Katz-Agranov, N; Leaf, DE; Moreno, D; Ouyang, T; Reynolds, KL; Seethapathy, H; Sise, ME; Strohbehn, IA; Wang, Q, 2023
)
0.91
"07), baclofen toxic effects (5 of 19 [26%] vs 0 of 11; P = ."( Medication-Related Adverse Events and Discordancies in Cystatin C-Based vs Serum Creatinine-Based Estimated Glomerular Filtration Rate in Patients With Cancer.
Gupta, S; Hanna, PE; Harden, D; Katz-Agranov, N; Leaf, DE; Moreno, D; Ouyang, T; Reynolds, KL; Seethapathy, H; Sise, ME; Strohbehn, IA; Wang, Q, 2023
)
0.91
" There were several adverse events of co-trimoxazole, however, a quantitative analysis was not conducted as the data did not include quantitative values in most studies."( Efficacy and safety of co-trimoxazole in eradication phase of melioidosis; systematic review.
Gunathilaka, MGRSS; Jayaweera, JAAS; Keragala, KARK; Senevirathna, RMISK, 2023
)
0.91
" The use of co-trimoxazole over the maintenance phase of melioidosis is associated with clinical cure but has adverse effects."( Efficacy and safety of co-trimoxazole in eradication phase of melioidosis; systematic review.
Gunathilaka, MGRSS; Jayaweera, JAAS; Keragala, KARK; Senevirathna, RMISK, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
" The mean half-life of TMP was 28 h, while for SMX it was 12."( Trimethoprim-sulfamethoxazole pharmacokinetics during continuous ambulatory peritoneal dialysis (CAPD).
Churchill, DN; Manuel, MA; Ojo, B; Paton, TW; Walker, SE; Wright, N, 1989
)
0.28
"05) between the control and treatment phases with respect to any of the following pharmacokinetic parameters of TH: area under the plasma total TH concentration time curve; fraction unbound in plasma; area under the plasma unbound TH concentration time curve; terminal half-life; apparent volume of distribution; apparent total plasma clearance and renal clearance."( Lack of effect of co-trimoxazole on the pharmacokinetics of orally administered theophylline.
Lo, KF; Nation, L; Sansom, LN,
)
0.13
" Plasma and dialysate concentrations were monitored for 1 exchange after administration of a single oral or intraperitoneal dose of co-trimoxazole, and were fitted by a pharmacokinetic model that took into account the equilibrium nature of CAPD by including return from the peritoneum in oral studies and from the plasma in intraperitoneal studies."( Co-trimoxazole (sulphamethoxazole plus trimethoprim) peritoneal barrier transfer pharmacokinetics.
O'Flaherty, EJ; Pesce, AJ; Singh, S; Svirbely, JE, 1989
)
0.28
" It is concluded that there is no consistent pharmacokinetic interaction between glibenclamide and trimethoprim-sulphamethoxazole in NIDDM patients."( Lack of pharmacokinetic interaction between glibenclamide and trimethoprim-sulphamethoxazole.
Christenson, I; Emilsson, H; Gunnarsson, R; Ostman, J; Sjöberg, S; Thunberg, E; Wiholm, BE,
)
0.13
"The objective of this study was to determine both the pharmacokinetic parameters and the bioavailability of a newly developed trimethoprim/sulfamethoxazole preparation (cotrimoxazole, Kepinol forte, 160 mg of trimethoprim/800 mg of sulfamethoxazole) in comparison with a reference preparation customary in trade and registered according to the AMG 1976, after single oral administration."( [Studies of the pharmacokinetics and bioavailability of a new trimethoprim/sulfamethoxazole preparation in healthy volunteers].
Hutt, V; Jaeger, H; Klingmann, I; Nieder, M; Pabst, GU; Salama, Z, 1988
)
0.27
" Quinolones and the calcium salt of fosfomycin are useful but do not have an ideal pharmacokinetic profile."( The microbiological and pharmacokinetic profile of an antibacterial agent useful for the single-dose therapy of urinary tract infection.
Greenwood, D; Slack, R, 1987
)
0.27
" Trimethoprim was found in higher concentrations in the sputum than in the blood, although there were wide and significant variations in individual patient's sputum pharmacokinetic profiles."( Trimethoprim alone compared to co-trimoxazole in lower respiratory infections: pharmacokinetics and clinical effectiveness.
Brumfitt, W; Hamilton-Miller, JM; Havard, CW; Tansley, H, 1985
)
0.27
" Following oral administration of a single dose, the pharmacokinetic parameters of SMZ and its N4-acetylated metabolite (N4SMZ) were similar in both groups."( Pharmacokinetics of the trimethoprim-sulphamethoxazole combination in the elderly.
Advenier, C; Cordonnier, P; Ducreuzet, C; Gobert, C; Lajoie, D; Pays, M; Varoquaux, O, 1985
)
0.27
" The half-life of TMP and SMXA determined by model independent methods were 33."( Trimethoprim-sulfamethoxazole pharmacokinetics during continuous ambulatory peritoneal dialysis.
Blevins, RB; Halstenson, CE; Matzke, GR; Salem, NG, 1984
)
0.27
" Factors contributing to the transport of solutes through the peritoneal membrane are discussed and the literature concerning the pharmacokinetic aspects of CAPD is reviewed."( Pharmacokinetic aspects during continuous ambulatory peritoneal dialysis: a literature review.
Janknegt, R; Koks, CH, 1984
)
0.27
" Pharmacokinetic analysis was based upon "one compartment model"."( Pharmacokinetic analysis of the level of sulfonamide-trimethoprim combination in calves.
Duda, M; Roliński, Z,
)
0.13
" The pharmacokinetic analysis showed a plasma elimination half-life in the terminal phase of 10."( Pharmacokinetics of co-trimoxazole and co-tetroxazine in geriatric patients.
Naber, K; Vergin, H; Weigand, W, 1981
)
0.26
" Pharmacokinetic studies in dogs show that trimethoprim readily reaches therapeutic levels in prostatic fluid, yet clinical studies indicate that only about one-third of men with chronic bacterial prostatitis are cured of infection after prolonged therapy with trimethoprim-sulfamethoxazole."( Prostatitis: review of pharmacokinetics and therapy.
Meares, EM,
)
0.13
" Pharmacokinetic parameters (volume of distribution, bioavailability and total body clearance) for TMP and SDZ were calculated and compared."( A comparative study of the pharmacokinetics of intravenous and oral trimethoprim/sulfadiazine formulations in the horse.
Breukink, HJ; Kessels, BG; Mevius, DJ; Sloet van Oldruitenborghoosterbaan, MM; van Duijkeren, E; van Miert, AS; Vulto, AG, 1994
)
0.29
"The pharmacokinetic behaviour of sulphamethoxazole and trimethoprim was studied after combined intravenous (i."( Pharmacokinetics of sulphamethoxazole and trimethoprim administered intravenously and orally to Japanese quails.
Lashev, LD; Mihailov, R, 1994
)
0.29
"To characterize the pharmacokinetic profile of trimethoprim-sulfamethoxazole (TMP-SMX) in trauma patients and to compare these parameter estimates with those obtained in nontrauma patients."( Trimethoprim-sulfamethoxazole pharmacokinetics in trauma patients.
Boucher, BA; Croce, MA; Fabian, TC; Hess, MM; Janning, SW; Laizure, SC; Sanders, PL; Stevens, RC,
)
0.13
"Open-label, multidose, pharmacokinetic study."( Trimethoprim-sulfamethoxazole pharmacokinetics in trauma patients.
Boucher, BA; Croce, MA; Fabian, TC; Hess, MM; Janning, SW; Laizure, SC; Sanders, PL; Stevens, RC,
)
0.13
" Comparison of the pharmacokinetic parameters in this study with those of our previous findings indicates that the elimination of trimethoprim-sulfamethoxazole follows a first-order process within the dose ranges assessed."( Multiple-dose pharmacokinetics of 12 milligrams of trimethoprim and 60 milligrams of sulfamethoxazole per kilogram of body weight per day in healthy volunteers.
Laizure, SC; Sanders, PL; Stein, DS; Stevens, RC, 1993
)
0.29
" The pharmacokinetic parameters of the sulfonamides as well as their main metabolites (acetyl sulfonamides) were not significantly different in healthy and febrile pigs."( Pharmacokinetics of sulfadimethoxine and sulfamethoxazole in combination with trimethoprim after intravenous administration to healthy and pneumonic pigs.
Kuiper, HA; Mengelers, MJ; Pijpers, A; Van Gogh, ER; Van Miert, AS; Verheijden, JH, 1995
)
0.29
" In theory, short half-life compounds reduce the selective pressure for resistance, which may be a major determinant of the useful therapeutic life of an antimalarial drug."( Pharmacology and pharmacokinetics of new antimalarials.
Watkins, WM, 1995
)
0.29
"A population pharmacokinetic model of intravenously and orally administered trimethoprim in patients with acquired immunodeficiency syndrome and Pneumocystis carinii pneumonia has been made using a parametric iterative two-stage Bayesian and a nonparametric expectation maximization computer program."( A population pharmacokinetic model of trimethoprim in patients with pneumocystis pneumonia, made with parametric and nonparametric methods.
Gomis, P; Jelliffe, RW; Ruskin, J; Sattler, FR; Tahani, B, 1997
)
0.3
"The objective of this study was to assess both pharmacokinetic properties and bioavailability of a newly developed cotrimoxazole preparation (Bioprim tablets, 80 mg of trimethoprim/400 mg sulfamethoxazole), in comparison with a reference preparation commercially available (Bactrim tablets, 80 mg of trimethoprim/400 mg of sulfamethoxazole)."( Comparative pharmacokinetics and bioavailability of two cotrimoxazole preparations.
Brzaković, B; Galetin, A; Miljković, B; Pokrajac, M; Simić, D, 1998
)
0.3
" This pharmacokinetic interaction study was nested within a larger Phase III clinical trial conducted to characterize the safety and efficacy of coadministered nevirapine and lamivudine."( Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection.
Lamson, MJ; Leitz, G; MacGregor, TR; Sabo, JP; Yong, CL, 2000
)
0.31
" Serum concentration-time curve for each animal was analyzed separately to estimate noncompartmental pharmacokinetic variables."( Pharmacokinetics of sulfamethoxazole and trimethoprim in donkeys, mules, and horses.
Matthews, NS; Mealey, KL; Peck, KE; Taylor, TS, 2002
)
0.31
" Due to increasing resistance of causative pathogens, antibiotics should be used by considering their pharmacodynamic and pharmacokinetic characteristics."( Pharmacokinetic and pharmacodynamic aspects of antimicrobial agents for the treatment of uncomplicated urinary tract infections.
Arrigucci, S; Cassetta, MI; Fallani, S; Mazzei, T; Novelli, A, 2006
)
0.33
" This study was performed to investigate potential pharmacokinetic interactions between apricitabine and trimethoprim-sulphamethoxazole."( Pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers treated with trimethoprim-sulphamethoxazole.
Cox, S; Sawyer, J; Shiveley, L; Struthers-Semple, C, 2008
)
0.35
"To assess the potential of cotrimoxazole and tenofovir, drugs which are inhibitors and/or substrates of renal transporters, to alter the pharmacokinetic profile of maraviroc."( The effects of cotrimoxazole or tenofovir co-administration on the pharmacokinetics of maraviroc in healthy volunteers.
Abel, S; Muirhead, GJ; Ridgway, CE; Russell, D; Whitlock, LA, 2008
)
0.35
"0 software to get the related pharmacokinetic parameters."( [Pharmacokinetics of sulfamethoxazole in healthy Han volunteers living at plain and in native Han and Tibetan healthy volunteers living at high altitude].
Li, XY; Li, YP; Liu, YN; Yuan, M; Zhu, JB, 2011
)
0.37
" Pharmacokinetic studies for TMP/SMX dosing in this patient population are necessary to allow adequate dosing."( Cotrimoxazole plasma levels, dialyzer clearance and total removal by extended dialysis in a patient with acute kidney injury: risk of under-dosing using current dosing recommendations.
Beutel, G; Clajus, C; Kielstein, JT; Kühn-Velten, WN; Lorenzen, JM; Pietsch, D; Schmidt, JJ, 2013
)
0.39
" TMP/SMX CRRT doses were modeled using CLtm and published TMP/SMX pharmacokinetic parameters."( Trimethoprim and sulfamethoxazole transmembrane clearance during modeled continuous renal replacement therapy.
Argyres, DP; Kesner, JM; Mercier, RC; Vilay, AM; Walker, SE; Wong, CS; Yardman-Frank, JM, 2014
)
0.4
" Since mefloquine is being considered as a replacement for sulfadoxine/pyrimethamine in this vulnerable population, an investigation on the pharmacokinetic interactions of mefloquine, sulfamethoxazole and trimethoprim in pregnant, HIV-infected women was performed."( Pharmacokinetics of mefloquine and its effect on sulfamethoxazole and trimethoprim steady-state blood levels in intermittent preventive treatment (IPTp) of pregnant HIV-infected women in Kenya.
Desai, M; González, R; Green, M; Kariuki, S; Katana, A; Menendez, C; Otieno, K; Ouma, P; Slutsker, L; ter Kuile, F, 2016
)
0.43
" Non-compartmental methods using a naïve-pooled data approach were used to determine mefloquine pharmacokinetic parameters."( Pharmacokinetics of mefloquine and its effect on sulfamethoxazole and trimethoprim steady-state blood levels in intermittent preventive treatment (IPTp) of pregnant HIV-infected women in Kenya.
Desai, M; González, R; Green, M; Kariuki, S; Katana, A; Menendez, C; Otieno, K; Ouma, P; Slutsker, L; ter Kuile, F, 2016
)
0.43
" There are no studies describing the pharmacodynamic interactions between tedizolid and other orally bioavailable antimicrobials."( Exploring the pharmacodynamic interactions between tedizolid and other orally bioavailable antimicrobials against Staphylococcus aureus and Staphylococcus epidermidis.
Werth, BJ, 2017
)
0.46
"The aims of this study were to (1) determine whether opportunistically collected data can be used to develop physiologically based pharmacokinetic (PBPK) models in pediatric patients; and (2) characterize age-related maturational changes in drug disposition for the renally eliminated and hepatically metabolized antibiotic trimethoprim (TMP)-sulfamethoxazole (SMX)."( Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children.
Balevic, SJ; Cobbaert, M; Cohen-Wolkowiez, M; Cunningham, AP; Edginton, AN; Hornik, CP; Maharaj, A; Thompson, EJ; Wu, H, 2019
)
0.51
"We successfully developed a pediatric PBPK model of the combination antibiotic TMP-SMX using sparse and opportunistic pediatric pharmacokinetic samples."( Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children.
Balevic, SJ; Cobbaert, M; Cohen-Wolkowiez, M; Cunningham, AP; Edginton, AN; Hornik, CP; Maharaj, A; Thompson, EJ; Wu, H, 2019
)
0.51
"The antibiotic combination trimethoprim (TMP)-sulfamethoxazole (SMX) has a broad spectrum of activity and is used for the treatment of numerous infections, but pediatric pharmacokinetic (PK) data are limited."( External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole.
Autmizguine, J; Cobbaert, M; Cohen-Wolkowiez, M; Gerhart, JG; Gonzalez, D; Hornik, CP; Wu, YSS, 2021
)
0.62
" Physiologically based pharmacokinetic modeling can bridge the gap in the understanding of how pharmacokinetics, including drug distribution and clearance, changes with obesity by incorporating known obesity-related physiological changes in children."( Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling.
Carreño, FO; Cohen-Wolkowiez, M; Edginton, AN; Ganguly, S; Gerhart, JG; Gonzalez, D; Harris, V; Hornik, CP; Kumar, KR; Perrin, EM; Rikhi, A; Sinha, J, 2022
)
0.72
"To enable physiologically based pharmacokinetic modeling, a virtual population of children with obesity was developed using national survey, electronic health record, and clinical trial data, as well as data extracted from the literature."( Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling.
Carreño, FO; Cohen-Wolkowiez, M; Edginton, AN; Ganguly, S; Gerhart, JG; Gonzalez, D; Harris, V; Hornik, CP; Kumar, KR; Perrin, EM; Rikhi, A; Sinha, J, 2022
)
0.72
" This study sought to define the pharmacodynamic indices and magnitude of exposure required for stasis and 1 log10 cfu reductions."( Trimethoprim/sulfamethoxazole pharmacodynamics against Stenotrophomonas maltophilia in the in vitro chemostat model.
Kuti, JL; Lasko, MJ; Nicolau, DP; Tabor-Rennie, JL, 2022
)
0.72
" Both the fAUC/MIC and fCmax/MIC were identified as equivalent pharmacodynamic drivers, with stasis achieved at an fAUC/MIC of 67."( Trimethoprim/sulfamethoxazole pharmacodynamics against Stenotrophomonas maltophilia in the in vitro chemostat model.
Kuti, JL; Lasko, MJ; Nicolau, DP; Tabor-Rennie, JL, 2022
)
0.72
" A total of 275 concentrations from 13 pediatric patients were used to build a polulation pharmacokinetic model using a nonlinear mixed-effects modeling approach."( Population Pharmacokinetics of Tacrolimus in Pediatric Patients With Umbilical Cord Blood Transplant.
Chen, J; Guo, Y; Shang, Y; Sun, Y; Xu, G; Zhu, L; Zuo, M, 2023
)
0.91

Compound-Compound Interactions

ExcerptReferenceRelevance
" We conclude that terbutaline given alone counteracts the loss of plasma volume during septicaemia and, when combined with a chemotherapeutic and dexamethasone, significantly improves long term survival."( Septic shock in rats treated with terbutaline alone and in combination with chemotherapeutics, dexamethasone, and infusion of 3% albumin.
Dawidson, I; Ottosson, J; Persson, T; Svensjö, E, 1992
)
0.28
" This case suggests that, when TMP/SMX is combined with glipizide, patients should be closely monitored, especially those at high risk for hypoglycemia."( Symptomatic hypoglycemia secondary to a glipizide-trimethoprim/sulfamethoxazole drug interaction.
Dobmeier, ME; Johnson, JF, 1990
)
0.28
"We report the excellent therapeutic response obtained with amikacin alone and in combination with trimethoprim-sulfamethoxazole in the treatment of 15 patients with actinomycotic mycetoma who had a poor response to the traditional pharmacologic agents and/or in whom important organs such as lungs, spinal cord, and bone were involved."( Amikacin alone and in combination with trimethoprim-sulfamethoxazole in the treatment of actinomycotic mycetoma.
Gonzalez, J; Ocampo, J; Sauceda, E; Welsh, O, 1987
)
0.27
" Sulfamoxole (SMO), Sulfadiazine (SDZ) and Sulfadimidine (SDD) in combination with trimethoprim (TMP) were studied in 12 healthy volunteers."( Comparative pharmacokinetic study of four different sulfonamides in combination with trimethoprim in human volunteers.
Garg, SK; Ghosh, SS; Mathur, VS, 1986
)
0.27
"Experience with trimethoprim-sulfamethoxazole (TMP-SMZ) alone or in combination with other agents in the treatment of immunocompromised patients other than those with Pneumocystis carinii pneumonitis and the acquired immunodeficiency syndrome is reviewed."( Use of trimethoprim-sulfamethoxazole singly and in combination with other antibiotics in immunocompromised patients.
Hindler, J; Young, LS,
)
0.13
"We explored the antibacterial activity of phosphanilic acid (P), an analog of sulfanilic acid, alone and in combination with trimethoprim (T; TP, 1:5) with sulfamethoxazole (S) and co-trimoxazole, the combination of this sulfonamide with trimethoprim (TS, 1:5) as the reference."( Antibacterial activity of phosphanilic acid, alone and in combination with trimethoprim.
Buck, RE; Chisholm, DR; Leitner, F; Misiek, M; Price, KE; Pursiano, TA; Tsai, YH, 1985
)
0.27
"A double-blind, multi-centre trial was carried out in 72 patients with acute or chronic infections of the lower respiratory tract to compare the efficacy and tolerance of a sulfamethopyrazine (200 mg)/trimethoprim (250 mg) combination with that of the established combination co-trimoxazole (400 mg sulphamethoxazole plus 80 mg trimethoprim)."( A multi-centre trial comparing a sulfamethopyrazine/trimethoprim combination with co-trimoxazole in respiratory tract infections.
Bagnato, A; Colombo, F; Colombo, ML; Dei, D; Donno, L; Ginesu, F; Ortu, AR; Peona, V, 1984
)
0.27
"The prophylactic efficacies of atovaquone (ATQ) alone and in combination with azithromycin, clarithromycin, rifabutin, proguanil, PS-15, trimethoprim, co-trimoxazole, or dapsone were investigated in a SCID mouse model of Pneumocystis carinii pneumonia (PCP)."( Effect of atovaquone and atovaquone drug combinations on prophylaxis of Pneumocystis carinii pneumonia in SCID mice.
Comley, JC; Sterling, AM, 1995
)
0.29
" in combination with 5 mg trimethoprim (TMP) per kg body weight."( Pharmacokinetics of sulfadimethoxine and sulfamethoxazole in combination with trimethoprim after intravenous administration to healthy and pneumonic pigs.
Kuiper, HA; Mengelers, MJ; Pijpers, A; Van Gogh, ER; Van Miert, AS; Verheijden, JH, 1995
)
0.29
" The magnitude of the changes in didanosine CLR and %UR values was no greater when both trimethoprim and sulphamethoxazole were coadministered vs when each single agent was given with didanosine, suggesting that any effect was not additive."( A pharmacokinetic interaction study of didanosine coadministered with trimethoprim and/or sulphamethoxazole in HIV seropositive asymptomatic male patients.
Barbhaiya, RH; Batteiger, B; Knupp, CA; Smith, RA; Srinivas, NR, 1996
)
0.29
"The in-vitro activity of rifabutin and albendazole alone and in combination with clarithromycin, etoposide, minocycline and pyrimethamine was investigated against four clinical isolates of Pneumocystis carinii."( In-vitro activity of rifabutin and albendazole singly and in combination with other clinically used antimicrobial agents against Pneumocystis carinii.
Barchiesi, F; Cirioni, O; Fortuna, M; Giacometti, A; Scalise, G, 1999
)
0.3
"Killing kinetic experiments were performed with moxifloxacin, a novel fluoroquinolone, vancomycin, clarithromycin, cotrimoxazole, gentamicin, rifampicin and with moxifloxacin in combination with each of the above drugs against six methicillin-resistant Staphylococcus aureus clinical isolates."( In-vitro activity of moxifloxacin combined with other antibacterials against methicillin-resistant Staphylococcus aureus.
Bottura, P; Capra, R; Maggiolo, F; Migliorino, M; Pravettoni, G; Suter, F, 2000
)
0.31
"The pharmacokinetics were studied of sulfadimethoxine (SDM) or sulfamethoxazole (SMX) in combination with trimethoprim (TMP) administered as a single oral dose (25 mg + 5 mg per kg body weight) to two groups of 6 healthy pigs."( Pharmacokinetics of sulfadimethoxine and sulfamethoxazole in combination with trimethoprim after oral single- and multiple-dose administration to healthy pigs.
Hougee, PE; Huveneers, MB; Kuiper, HA; Mengelers, MJ; Pijpers, A; van Gogh, ER; van Miert, AS; Verheijden, JH, 2001
)
0.31
"Many hospital admissions of elderly patients for drug toxicity occur after administration of a drug known to cause drug-drug interactions."( Drug-drug interactions among elderly patients hospitalized for drug toxicity.
Juurlink, DN; Kopp, A; Laupacis, A; Mamdani, M; Redelmeier, DA, 2003
)
0.32
"Two antibiotic regimens are used commonly in Thailand for the initial treatment of severe melioidosis: ceftazidime in combination with trimethoprim-sulfamethoxazole (TMP-SMX) and ceftazidime monotherapy."( Two randomized controlled trials of ceftazidime alone versus ceftazidime in combination with trimethoprim-sulfamethoxazole for the treatment of severe melioidosis.
Anunnatsiri, S; Chaowagul, W; Cheng, AC; Chetchotisakd, P; Chierakul, W; Day, NP; Limmathurotsakul, D; Maharjan, B; Mootsikapun, P; Newton, PN; Peacock, SJ; Short, JM; Simpson, AJ; Stepniewska, K; White, NJ, 2005
)
0.33
" The purpose of our study was to determine which drugs used in combination with MTX (excluding disease modifying antirheumatic drugs, folic and folinic acid, corticosteroids, and biologic agents) enhance side effects or toxicity of MTX or lower its efficacy."( Methotrexate drug interactions in the treatment of rheumatoid arthritis: a systematic review.
Bourré-Tessier, J; Haraoui, B, 2010
)
0.36
" Treatment with linezolid combined with TMP-SMZ resulted in a clear clinical improvement and bacterial clearance."( Linezolid combined with trimethoprim-sulfamethoxazole therapy for the treatment of disseminated nocardiosis.
Li, H; Shen, Q; Zhou, H; Zhou, J, 2011
)
0.37
" We also found that ATRA in combination with primaquine was as effective as the combination of trimethoprim and sulfamethaxazole for treatment of PcP and completely eliminated MDSCs and Pc organisms in the lungs in two weeks."( All-trans retinoic acid in combination with primaquine clears pneumocystis infection.
Durant, PJ; Jung, HW; Lee, CH; Lei, GS; Shao, S; Zhang, C, 2013
)
0.39
" These data suggest that the administration of low doses of caspofungin in combination with low doses of TMP-SMX may provide an improved treatment protocol for Pneumocystis infection clearance."( Therapeutic potential of caspofungin combined with trimethoprim-sulfamethoxazole for pneumocystis pneumonia: a pilot study in mice.
Antunes, F; Cardoso, F; Cushion, MT; de Sousa, B; Esteves, F; Lobo, ML; Matos, O, 2013
)
0.39
"Trimethoprim-sulfamethoxazole alone and combined with colistin was tested in vitro against six carbapenem-resistant Acinetobacter baumannii (CRAB) clinical strains."( In Vitro Bactericidal Activity of Trimethoprim-Sulfamethoxazole Alone and in Combination with Colistin against Carbapenem-Resistant Acinetobacter baumannii Clinical Isolates.
Kraniotaki, E; Nepka, M; Perivolioti, E; Politi, L; Pournaras, S; Tsakris, A, 2016
)
0.43
"Caspofungin combined with clindamycin is an optional treatment for PCP when treatment with TMP-SMZ fails or in patients who cannot tolerate TMP-SMZ."( Successful treatment of severe Pneumocystis pneumonia in an immunosuppressed patient using caspofungin combined with clindamycin: a case report and literature review.
He, H; Huang, H; Li, H, 2016
)
0.43
"We reviewed data of 9 patients admitted with SLE-PCP and treated with caspofungin combined with coSMZ at Tangshan Gongren Hospital from January 2013 to December 2017."( A retrospective study of patients with systemic lupus erythematosus combined with Pneumocystis jiroveci pneumonia treated with caspofungin and trimethoprim/sulfamethoxazole.
Chen, NF; Liu, XM; Tong, SQ; Wang, Q; Wang, ZG, 2019
)
0.51
" However, the availability of clinical data about caspofungin combined with TMP/SMZ in the treatment of PCP in HIV-infected patients is limited."( Caspofungin combined with TMP/SMZ as a first-line therapy for moderate-to-severe PCP in patients with human immunodeficiency virus infection.
Huang, B; Jiang, F; Jiang, Z; Li, Q; Si, J; Tian, Q; Wei, B; Xu, R; Zhao, T, 2021
)
0.62
"From January 2017 to December 2019, data of HIV-infected patients with moderate-to-severe PCP who received either TMP/SMZ alone or caspofungin combined with TMP/SMZ as first-line therapy were retrospectively reviewed to assess the effectiveness and safety of each regimen."( Caspofungin combined with TMP/SMZ as a first-line therapy for moderate-to-severe PCP in patients with human immunodeficiency virus infection.
Huang, B; Jiang, F; Jiang, Z; Li, Q; Si, J; Tian, Q; Wei, B; Xu, R; Zhao, T, 2021
)
0.62
" The patient's condition continued to deteriorate, and then underwent endotracheal intubation and veno-venous extracorporeal membrane oxygenation (VV-ECMO) combined with prone position ventilation until the lung lesion improved."( VV-ECMO combined with prone position ventilation in the treatment of Pneumocystis jirovecii pneumonia: A case report.
Bai, Y; Du, Q; Jia, L; Zhang, Z, 2022
)
0.72
"VV-ECMO combined with prone position ventilation could be a useful choice for respiratory assistance in non-HIV PJP patients."( VV-ECMO combined with prone position ventilation in the treatment of Pneumocystis jirovecii pneumonia: A case report.
Bai, Y; Du, Q; Jia, L; Zhang, Z, 2022
)
0.72
" The objective of this study was to review the all-cause mortality and efficacy of echinocandins combined with trimethoprim/sulfamethoxazole (TMP/SMZ) for the treatment of PCP."( Meta-analysis of echinocandins combined with trimethoprim-sulfamethoxazole for treatment of Pneumocystis pneumonia.
Chen, Z; Guo, J; Kong, C; Liu, Y; Qiu, T; Wang, T; Yu, B; Zhang, Y; Zhou, J, 2023
)
0.91
"This retrospective case series indicates that SCoRCH (sudden conjunctivitis, lymphopenia, and rash combined with hemodynamic changes) should be considered in the differential diagnosis of patients presenting with acute generalized sunburn-like erythema, conjunctivitis, systemic symptoms, and hemodynamic changes in the setting of recent TMP-SMX use."( Sudden Conjunctivitis, Lymphopenia, and Rash Combined With Hemodynamic Changes (SCoRCH) After Trimethoprim-Sulfamethoxazole Use: A Case Series Study of a Hypersensitivity Reaction.
Dominguez, AR; Mauskar, MM; O'Brian, M; Rose, EK, 2023
)
0.91
"Sudden conjunctivitis, lymphopenia, and rash combined with hemodynamic changes (SCoRCH) is a recently described hypersensitivity reaction to trimethoprim-sulfamethoxazole."( Expanding the Histologic Spectrum of Sudden Conjunctivitis, Lymphopenia, and Rash Combined With Hemodynamic Changes.
Elsensohn, A; Ibraheim, MK; Kearns, D; Kraus, C; Lee, MP; Ticknor, IL, 2023
)
0.91

Bioavailability

ExcerptReferenceRelevance
" dose, the bioavailability following oral administration for TMP was 98% and 87% for SMX."( Trimethoprim-sulfamethoxazole pharmacokinetics during continuous ambulatory peritoneal dialysis (CAPD).
Churchill, DN; Manuel, MA; Ojo, B; Paton, TW; Walker, SE; Wright, N, 1989
)
0.28
" The resultant decreased bioavailability of cyclosporine may precipitate graft rejection."( Interactions of cyclosporine with antimicrobial agents.
Brown, RB; Sands, M,
)
0.13
"The objective of this study was to determine both the pharmacokinetic parameters and the bioavailability of a newly developed trimethoprim/sulfamethoxazole preparation (cotrimoxazole, Kepinol forte, 160 mg of trimethoprim/800 mg of sulfamethoxazole) in comparison with a reference preparation customary in trade and registered according to the AMG 1976, after single oral administration."( [Studies of the pharmacokinetics and bioavailability of a new trimethoprim/sulfamethoxazole preparation in healthy volunteers].
Hutt, V; Jaeger, H; Klingmann, I; Nieder, M; Pabst, GU; Salama, Z, 1988
)
0.27
" It is suggested that the bioavailability and thereby, the antileukaemic effect) during maintenance therapy of ALL of 6-MP may be decreased by the co-administration of CTX."( The effect of cotrimoxazole on the absorption of orally administered 6-mercaptopurine in the rat.
Aherne, GW; Burton, NK, 1986
)
0.27
"The relative bioavailability of a co-trimoxazole suspension manufactured by VEB Berlin-Chemie (B); Belocid-Suspension was compared with a widespread used suspension (V) in healthy male students (22-29 ys."( [The relative bioavailability of co-trimoxazole suspensions].
Günther, C; Traeger, A; Truckenbrodt, J, 1987
)
0.27
"An in vitro study was made of the bactericidal activity against Escherichia coli of fosfomycin trometamol, a new fosfomycin salt characterized by high bioavailability in relation to the pH, inoculum and culture medium, the latter being nutrient broth or human urine."( Influence of pH, inoculum and media on the in vitro bactericidal activity of fosfomycin trometamol, norfloxacin and cotrimoxazole.
Albini, E; Belluco, G; Marca, G, 1986
)
0.27
" The agent must therefore be well absorbed and have slow renal excretion."( The microbiological and pharmacokinetic profile of an antibacterial agent useful for the single-dose therapy of urinary tract infection.
Greenwood, D; Slack, R, 1987
)
0.27
" Either the necessity to optimize bioavailability because of the underlying seriousness of disease or a desire to avoid other drugs that may be responsible for adverse reactions or hypersensitivity should direct the clinician to administer an intravenous preparation."( Use of trimethoprim-sulfamethoxazole in pediatric infections: relative merits of intravenous administration.
Overturf, GD,
)
0.13
" P was well absorbed parenterally but not orally in mice."( Antibacterial activity of phosphanilic acid, alone and in combination with trimethoprim.
Buck, RE; Chisholm, DR; Leitner, F; Misiek, M; Price, KE; Pursiano, TA; Tsai, YH, 1985
)
0.27
" Absorption appeared to be similar between the critically ill and non-critically patients: bioavailability was 97."( Pharmacokinetics of trimethoprim-sulfamethoxazole in critically ill and non-critically ill AIDS patients.
Chin, TW; Fong, IW; Vandenbroucke, A, 1995
)
0.29
" Pharmacokinetic parameters (volume of distribution, bioavailability and total body clearance) for TMP and SDZ were calculated and compared."( A comparative study of the pharmacokinetics of intravenous and oral trimethoprim/sulfadiazine formulations in the horse.
Breukink, HJ; Kessels, BG; Mevius, DJ; Sloet van Oldruitenborghoosterbaan, MM; van Duijkeren, E; van Miert, AS; Vulto, AG, 1994
)
0.29
" The bioavailability was 81% for sulphamethoxazole and 41% for trimethoprim."( Pharmacokinetics of sulphamethoxazole and trimethoprim administered intravenously and orally to Japanese quails.
Lashev, LD; Mihailov, R, 1994
)
0.29
" The method was used to compare the bioavailability of two tablet formulations in terms of their pharmacokinetic parameters following oral administration of the tablets to 18 volunteers."( Analysis and bioequivalency study on two tablet formulations of co-trimoxazole.
Alkaysi, HN; Amari, FF; Gharaibeh, AM; Sallam, E; Sheikh Salem, M; Shubair, MS, 1993
)
0.29
"To determine the bioavailability of trimethoprim-sulfamethoxazole (TMP-SMX) in patients infected with the human immunodeficiency virus (HIV)."( Oral absorption of trimethoprim-sulfamethoxazole in patients with AIDS.
Banevicius, MA; Belliveau, PP; Broisman, L; Klepser, ME; Nicolau, DP; Nightingale, CH; Quintiliani, R; Ross, JW; Zhu, Z,
)
0.13
" It is usually administered orally and is well absorbed after oral ingestion."( [Urinary tract infections: risk factors and therapeutic trends].
Astorri, AL; Margariti, PA; Mastromarino, C, 1997
)
0.3
"The objective of this study was to assess both pharmacokinetic properties and bioavailability of a newly developed cotrimoxazole preparation (Bioprim tablets, 80 mg of trimethoprim/400 mg sulfamethoxazole), in comparison with a reference preparation commercially available (Bactrim tablets, 80 mg of trimethoprim/400 mg of sulfamethoxazole)."( Comparative pharmacokinetics and bioavailability of two cotrimoxazole preparations.
Brzaković, B; Galetin, A; Miljković, B; Pokrajac, M; Simić, D, 1998
)
0.3
" No correlation was found between the degree of gastrointestinal damage and the presumed bioavailability of co-trimoxazole as estimated from serum levels of trimethoprim and sulphamethoxazole."( Gastrointestinal damage induced by cytostatic treatment does not affect the bioavailability of co-trimoxazole.
Höglund, P; Johnsson, A; Ljungberg, B; Nilsson-Ehle, I; Nyhlén, A,
)
0.13
"Many workers have attempted to determine the bioavailability of pharmaceutical formulations, which is important to assure the efficacy and safety of medications."( Comparative bioavailability of sulfamethoxazole in co-trimoxazole suspensions containing different thickness agents.
Bentley, MV; Lara, EH; Marchetti, JM; Shuhama, IK, 1999
)
0.3
"The pharmacokinetics and bioavailability of trimethoprim-sulfamethoxazole (TMP-SMX) were studied in six healthy male-castrate alpacas (Lama pacos) after intravenous (i."( Pharmacokinetics and bioavailability of trimethoprim-sulfamethoxazole in alpacas.
Chakwenya, J; Fales, WH; Holle, J; James-Kracke, M; Lakritz, J; Smith, K; Tyler, J, 2002
)
0.31
" Prosthesis retention, in conjunction with debridement and prolonged (for at least 3 months) oral antibiotic therapy, can be an alternative for early postoperative or late acute haematogenous infections, when the duration of symptoms is less than 1 month, the implant is stable, and the pathogen is relatively avirulent and sensitive to an orally well absorbed antibiotic."( Management of infections of osteoarticular prosthesis.
Barberán, J, 2006
)
0.33
" For "selective intestinal decontamination", poorly absorbed oral norfloxacin is the preferred schedule."( [Bacterial infections in liver cirrhosis].
Farkas, A; Papp, M; Tornai, I; Udvardy, M, 2007
)
0.34
"The objective of this study was to compare the bioavailability of 2 commercial preparations of T:MP/SMX 40/200 mg per 5-ml, oral suspension, used in Mexico for the treatment of bacterial infection."( Bioequivalence of two commercial preparations of trimethoprim/sulfamethoxazole: a randomized, single-dose, single-blind, crossover trial.
Alonso Campero, R; Bernardo Escudero, R; Burke Fraga, V; De Lago Acosta, A; Del Cisne Valle Alvarez, D; González de la Parra, M; Namur Montalvo, S; Silva Hernandez, R, 2007
)
0.34
" The objective of this animal study was to determine whether pre-treatment with antibiotics affects the intestinal bioavailability of Atazanavir (ATV) and Ritonavir (RTV)."( Metronidazole or Cotrimoxazole therapy is associated with a decrease in intestinal bioavailability of common antiretroviral drugs.
Desjeux, JF; Dossou-Yovo, F; Eto, B; Limas-Nzouzi, N; Mamadou, G; Miantezila, J; Soudy, ID, 2014
)
0.4
" Definitive drug quality was measured using high-performance liquid chromatography-photodiode array detection (HPLC-PDA) for content of the stated active pharmaceutical ingredients (APIs) and bioavailability was determined with in vitro dissolution testing."( Quality of the antibiotics--amoxicillin and co-trimoxazole from Ghana, Nigeria, and the United Kingdom.
Fadeyi, I; Kaur, H; Lalani, M; Mailk, N; Van Wyk, A, 2015
)
0.42
" Age had a significant positive correlation with bioavailability in a model that included allometric scaling."( Population Pharmacokinetics and Pharmacodynamics of Lumefantrine in Young Ugandan Children Treated With Artemether-Lumefantrine for Uncomplicated Malaria.
Arinaitwe, E; Aweeka, FT; Bergqvist, Y; Bigira, V; Blessborn, D; Creek, DJ; Kakuru, A; McCormack, SA; Muhindo, M; Parikh, S; Sambol, NC; Sukumar, N; Tappero, JW; Tchaparian, E; Wanzira, H, 2016
)
0.43
"Tedizolid is an orally bioavailable oxazolidinone with once-daily dosing and broad-spectrum Gram-positive activity."( Exploring the pharmacodynamic interactions between tedizolid and other orally bioavailable antimicrobials against Staphylococcus aureus and Staphylococcus epidermidis.
Werth, BJ, 2017
)
0.46
" The addition of other orally bioavailable anti-staphylococcal agents to tedizolid may be unlikely to improve killing but further research is warranted to assess the impact of these combinations on resistance prevention, or against biofilm-embedded organisms."( Exploring the pharmacodynamic interactions between tedizolid and other orally bioavailable antimicrobials against Staphylococcus aureus and Staphylococcus epidermidis.
Werth, BJ, 2017
)
0.46
"The management of some serious infections such as infective endocarditis (IE) and bone and joint infections (BJIs) caused by Gram-positive cocci (GPC) is complex and requires great responsiveness and effective antimicrobials with high bioavailability in heart valves or bone tissues."( Old antimicrobials and Gram-positive cocci through the example of infective endocarditis and bone and joint infections.
Amrane, S; Million, M; Seng, P; Stein, A, 2017
)
0.46

Dosage Studied

ExcerptRelevanceReference
" In conclusion, once-daily oral dosing with lomefloxacin is a safe and efficacious alternative to twice-daily dosing with TMP/SMX in the treatment of uncomplicated urinary tract infections."( Uncomplicated urinary tract infections: lomefloxacin versus trimethoprim/sulphamethoxazole.
Capron, MH; Guibert, J, 1992
)
0.28
" Two dosage regimens of cotrimoxazole were used: 40 mg/kg/day (12 patients) or 120 mg/kg/day (12 patients) of total compound (trimethoprim plus sulfamethoxazole)."( Cotrimoxazole therapy of Toxoplasma gondii encephalitis in AIDS patients.
Canessa, A; De Leo, P; Del Bono, V; Piersantelli, N; Terragna, A, 1992
)
0.28
" Pharmacokinetic data and clinical trials are reviewed, as well as adverse effects, drug interactions, and dosage guidelines."( Trimetrexate for Pneumocystis carinii pneumonia in patients with AIDS.
Amsden, GW; Kowalsky, SF; Morse, GD, 1992
)
0.28
" Although TMTX's pharmacokinetic parameters are variable, the need for plasma concentration monitoring at present is unclear, as no dose-response relationship has been established."( Trimetrexate for Pneumocystis carinii pneumonia in patients with AIDS.
Amsden, GW; Kowalsky, SF; Morse, GD, 1992
)
0.28
" When the creatinine clearance is less than 30 ml/min, the dosage of trimethoprim-sulfamethoxazole should be adjusted."( Trimethoprim-sulfamethoxazole.
Cockerill, FR; Edson, RS, 1991
)
0.28
"A simple spectrophotometric method for the determination of 15 sulphonamides in bulk and in dosage forms is described."( Use of p-benzoquinone for the spectrophotometric determination of certain sulphonamides.
Askal, HF; Mohamed, AM; Saleh, GA, 1991
)
0.28
" Dosage must be adjusted to the results of blood counts."( [Usefulness of folinic acid in cytopenia induced by antiparasitic drugs in AIDS patients].
Leport, C; Niyongabo, T; Vildé, JL, 1991
)
0.28
" Zidovudine dosage was adjusted 92 times in the other 31 children (52%), mostly due to neutropenia (83%)."( Low-dose zidovudine in children with an human immunodeficiency virus type 1 infection acquired in the perinatal period.
Blanche, S; Debré, M; Duliege, AM; Griscelli, C; Kouzan, S; Navarette, MS; Rouzioux, C; Seldrup, J; Tardieu, M, 1991
)
0.28
" Further studies are indicated in patients to optimize the dosing regimen of trimethoprim-sulfamethoxazole in the treatment of PCP."( Pharmacokinetics and adverse effects of 20-mg/kg/day trimethoprim and 100-mg/kg/day sulfamethoxazole in healthy adult subjects.
Laizure, SC; Stein, DS; Stevens, RC; Williams, CL, 1991
)
0.28
"All patients received two IV doses of trimethoprim/sulfamethoxazole at a 12-hour dosing interval and promethazine and acetaminophen as needed for nausea and fever, respectively."( Treatment of pyelonephritis in an observation unit.
Jorden, RC; Severance, HW; Ward, G, 1991
)
0.28
"57 mg/kg, showing activity greater than that of primaquine at this dosage and comparable to that of trimethoprim-sulfamethoxazole at 50/250 mg/kg."( 8-Aminoquinolines from Walter Reed Army Institute for Research for treatment and prophylaxis of Pneumocystis pneumonia in rat models.
Bartlett, MS; Berman, JD; Ellis, WY; Milhous, WK; Queener, SF; Smith, JW; Tidwell, RR, 1991
)
0.28
" Amifloxacin at a dosage of 200 mg twice a day appeared as safe and effective as TMP-SMX, but amifloxacin at 400 mg twice a day tended to cause adverse events more frequently than did TMP-SMX."( Randomized, controlled trial of a 10-day course of amifloxacin versus trimethoprim-sulfamethoxazole in the treatment of acute, uncomplicated urinary tract infection. Amifloxacin Multi-Center Trial Group.
Boyko, EJ; Iravani, A; Schelling, DJ; Silverman, MH; Wright, RA, 1990
)
0.28
"Each of seven mares was given an intravenous (IV) injection of 40% dimethyl sulfoxide (DMSO) at a dosage of 1 g/kg, over 35 min, immediately followed by a single IV injection of a trimethoprim (TMP) and sulfamethoxazole (SMZ) combination (SMZ 83%, TMP 17%) at a combined dosage of 44 mg/kg (7."( Concentrations of trimethoprim and sulfamethoxazole in cerebrospinal fluid and serum in mares with and without a dimethyl sulfoxide pretreatment.
Brown, MP; Green, SL; Gronwall, RR; Mayhew, IG; Montieth, G, 1990
)
0.28
" Neutropenia can also appear after low (prophylactic) dosage of TMP-SMX, and can be prevented by concomitant administration of folinic acid."( [Neutropenia caused by low-dose trimethoprim-sulfamethoxazole in children with chronic pathology of the urinary tract].
De Manzini, A; Lepore, L; Peratoner, L,
)
0.13
" In this prospective randomized study, norfloxacin and trimethoprim-sulfamethoxazole were given on the same dosage schedule with the former drug given as a 400-mg tablet twice daily and the latter drug given as a double strength tablet twice daily."( Treatment of recurrent urinary tract infection with norfloxacin versus trimethoprim-sulfamethoxazole.
Amy, BG; Childs, SJ; Hurst, AT; Krisch, EB; McCabe, RE; Seidmon, EJ; Truant, AL, 1990
)
0.28
" PGF-2 alpha treatment lasted 2-26 days and dosage varied from 26."( A retrospective study of 40 cases of canine pyometra-metritis treated with prostaglandin F-2 alpha and broad-spectrum antibacterial drugs.
Gilbert, RO; Nöthling, JO; Oettle, EE, 1989
)
0.28
" Guidelines for appropriate dosing and monitoring of TMP/SMX therapy in these patients are presented."( Clinical use of trimethoprim/sulfamethoxazole during renal dysfunction.
Nahata, MC; Paap, CM, 1989
)
0.28
" The 200-mg dosage of norfloxacin seemed to cause fewer side effects than the 400-mg dosage."( Coordinated multicenter study of norfloxacin versus trimethoprim-sulfamethoxazole treatment of symptomatic urinary tract infections. The Urinary Tract Infection Study Group.
, 1987
)
0.27
" Doubling of erythromycine dosage could not prevent premenstrual exacerbation of acne."( On therapeutic approaches to some special types of acne.
Rajka, G, 1985
)
0.27
" Intravenous TMP-SMX was begun at a dosage of 18 mg/kg/day of trimethoprim."( Treatment of Pneumocystis carinii pneumonia in patients with AIDS.
Hauptman, SP; Wordell, CJ, 1988
)
0.27
" Trimethoprim-sulfamethoxazole dosage was adjusted to maintain serum trimethoprim at 5 to 8 micrograms/mL."( Trimethoprim-sulfamethoxazole compared with pentamidine for treatment of Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome. A prospective, noncrossover study.
Cowan, R; Nielsen, DM; Ruskin, J; Sattler, FR, 1988
)
0.27
" Toxicity associated with the two standard treatments is rarely life-threatening and may be diminished if the trimethoprim-sulfamethoxazole dosage is modified by pharmacokinetic monitoring and the pentamidine dosage is reduced for nephrotoxicity."( Trimethoprim-sulfamethoxazole compared with pentamidine for treatment of Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome. A prospective, noncrossover study.
Cowan, R; Nielsen, DM; Ruskin, J; Sattler, FR, 1988
)
0.27
" Both dosage forms led to maximum plasma levels of approx."( [Studies of the pharmacokinetics and bioavailability of a new trimethoprim/sulfamethoxazole preparation in healthy volunteers].
Hutt, V; Jaeger, H; Klingmann, I; Nieder, M; Pabst, GU; Salama, Z, 1988
)
0.27
" The carbutamide dosage of 50 mg/kg per day prevented the infection in 90% of animals, whereas tolbutamide in the same dosage permitted infection in 100% of animals."( Effects of sulfonylurea compounds on Pneumocystis carinii.
Hughes, WT; Smith-McCain, BL, 1986
)
0.27
" The dosage yielded too high plasma trimethoprim concentrations, while sulfamethoxazole dialysate concentrations were too low."( Pharmacokinetics of cefradine, sulfamethoxazole and trimethoprim and their metabolites in a patient with peritonitis undergoing continuous ambulatory peritoneal dialysis.
Berden, JH; Hekster, YA; Martea, M; Voets, AJ; Vree, TB, 1987
)
0.27
" When the creatinine clearance decreases to less than 30 ml/min, the dosage of trimethoprim-sulfamethoxazole should be adjusted."( Trimethoprim-sulfamethoxazole.
Cockerill, FR; Edson, RS, 1987
)
0.27
"3 times as frequent with the "forte" dosage as compared to the 80 mg trimethoprim/400 mg sulfamethoxazole preparation."( Clinical and practitioners' reports on adverse effects of co-trimoxazole.
Auwärter, A; Ding, R; Gutzler, F; Jacubeit, T; Mörike, K; Walter-Sack, I; Weber, E, 1987
)
0.27
"025), bismuth subsalicylate (Pepto-Bismol) taken orally at a dosage of as low as 30 ml every half hour for eight doses was shown to be effective in reducing the frequently of episodes of diarrhea."( Nonantibiotic therapy for travelers' diarrhea.
DuPont, HL; Ericsson, CD; Johnson, PC,
)
0.13
" A significant dose-response effect was found with both amoxicillin and trimethoprim/sulfamethoxazole."( Antibiotic-associated gastrointestinal symptoms in general pediatric outpatients.
Contardi, R; Flegel, KM; Hutchinson, TA; Kramer, MS; Leduc, DG; Naimark, L, 1985
)
0.27
" The present study suggests that both drugs can be given concomitantly without the need for dosage adjustment of theophylline."( Lack of influence of co-trimoxazole on theophylline pharmacokinetics.
Hempenius, J; Holtkamp, AH; Jonkman, JH; Schoenmaker, R; Van der Boon, WJ, 1985
)
0.27
" A study of plasma concentrations of TMP, SMZ and N4SMZ during continuous dosing in seven elderly patients treated for urinary or respiratory infections showed that steady state was reached after 3 days of treatment and that plasma drug concentrations were about two to three times higher than those observed after a single dose."( Pharmacokinetics of the trimethoprim-sulphamethoxazole combination in the elderly.
Advenier, C; Cordonnier, P; Ducreuzet, C; Gobert, C; Lajoie, D; Pays, M; Varoquaux, O, 1985
)
0.27
" The dosage used for the new drug was 2 capsules (250 mg trimethoprim + 200 mg sulfamethopyrazine per capsule) the 1st day and 1 capsule for the following 14 days or 2 capsules (trimethoprim 80 mg + sulfamethoxazole 400 mg per capsule) twice daily for 15 days."( Effect of a new sulfa-trimethoprim combination (trimethoprim-sulfamethopyrazine) in typhoid fever. A double-blind study on 72 adult patients.
Piaia, F; Schiraldi, O; Sforza, E, 1985
)
0.27
" A symptom complex of fevers and increasing malaise, often with nausea and headaches, developed usually after 9 days of therapy at a daily dosage of 20 mg/kg of trimethoprim and 100 mg/kg of sulphamethoxazole."( Complications of co-trimoxazole in treatment of AIDS-associated Pneumocystis carinii pneumonia in homosexual men.
Abrams, DI; Ammann, AJ; Golden, JA; Jaffe, HS; Lewis, BJ, 1983
)
0.27
" The dosage of pivamdinocillin in adults was 400 to 800 mg, every 6 hours, for 10 to 16 days; dosage in children was half this amount for 11 to 15 days."( Management of enteric fever with amdinocillin.
Ball, AP; Geddes, AM, 1983
)
0.27
"The purpose of this study was to identify new drugs for the prevention and treatment of Pneumocystis carinii pneumonitis (PCP) induced in rats by continuous daily dosage with dexamethasone."( Efficacy of diaminodiphenylsulfone and other drugs in murine Pneumocystis carinii pneumonitis.
Hughes, WT; Smith, BL, 1984
)
0.27
" The new sulfa-trimethoprim combination showed activity similar to the reference drug, but it may have the advantage of a simpler dosage schedule."( Double-blind comparative trial of trimethoprim/sulfamethopyrazine once daily vs erythromycin 4 X daily in patients with ENT infections.
Federspil, P; Koch, J, 1983
)
0.27
" She recovered after surgical drainage of the abscesses and prolonged treatment with intravenous amikacin and high dosage cotrimoxazole and sulphadimidine."( Abdominal nocardiosis in a Sudanese girl.
Dickson, JA; Duerden, BI; Milner, RD; Salfield, SA, 1983
)
0.27
" The dissolution rates were dependent on the pH of the dissolution medium, the solubilities of the drugs at the pH involved, the dosage form and the brand studied."( Simultaneous in vitro and in vivo evaluation of both trimethoprim and sulfamethoxazole from certain dosage forms.
El-Sabbagh, H; Foda, A; Ghanem, A; Meshali, M, 1983
)
0.27
" Our data support the need for increased dosing or decreased dosing intervals when administering TMP-SMZ to patients with cystic fibrosis."( Dosing implications of rapid elimination of trimethoprim-sulfamethoxazole in patients with cystic fibrosis.
Bertino, JS; Blumer, JL; Myers, CM; Reed, MD; Stern, RC; Yamashita, TS, 1984
)
0.27
"2-82 years were treated intravenously with 150 mg of trimethoprim (TMP) and 750 mg of sulfamethoxazole (SMZ)/m2 every 8 hr, usually for known or suspected pneumocystis pneumonia; when necessary dosage was adjusted to maintain peak TMP levels of 5-10 micrograms/ml."( Pharmacokinetics of intravenous trimethoprim-sulfamethoxazole in children and adults with normal and impaired renal function.
Ericson, JF; Gorham, CC; Siber, GR; Smith, AL,
)
0.13
" Thus, a regimen involving initial intravenous therapy with doses of 15-20 mg/kg per day, with subsequent reduction of dosage or change to oral medication if improvement is rapid, was developed."( Trimethoprim-sulfamethoxazole in the treatment of adults with pneumonia due to Pneumocystis carinii.
Young, LS,
)
0.13
"Two dosage schedules of co-trimoxazole, the standard antibacterial and a 2-day high-dose schedule, were compared with a standard course of chloroquine in the treatment of uncomplicated Plasmodium falciparum malaria."( An evaluation of co-trimoxazole in the treatment of Plasmodium falciparum malaria.
Hansford, CF; Hoyland, J, 1982
)
0.26
"Responses of parasitemia and fever in vivax malaria to standard doses of chloroquine and different dosage schedules of co-trimoxazole were compared in 165 children."( A comparative trial of oral chloroquine and oral co-trimoxazole in vivax malaria in children.
Lal, H, 1982
)
0.26
" Dosage were made using HPLC after biological specimens had been treated on a TM C18 Set Pack column for deproteinization and isolation of the active substances."( [Bone diffusion of trimethoprim and sulfamethoxazole high pressure liquid chromatography (HPLC) (author's transl)].
Le Rebeller, A; Leng, B; Mintrosse, J; Saux, MC, 1982
)
0.26
" It is believed that traditional dosage regimens for uncomplicated UTIs are extravagant."( Management of lower urinary tract infections.
Bailey, RR, 1993
)
0.29
"Current dosage regimens of trimethoprim-sulfamethoxazole used to treat Pneumocystis carinii pneumonia in AIDS patients have been based on data from healthy subjects or patients without AIDS."( Pharmacokinetics of trimethoprim-sulfamethoxazole in critically ill and non-critically ill AIDS patients.
Chin, TW; Fong, IW; Vandenbroucke, A, 1995
)
0.29
" Eight fasted horses were dosed at 1 week intervals in a sequentially designed study with one intravenous (i."( A comparative study of the pharmacokinetics of intravenous and oral trimethoprim/sulfadiazine formulations in the horse.
Breukink, HJ; Kessels, BG; Mevius, DJ; Sloet van Oldruitenborghoosterbaan, MM; van Duijkeren, E; van Miert, AS; Vulto, AG, 1994
)
0.29
" ATQ drug combinations affected the prophylactic efficacy of a subcurative dosage of ATQ (50 mg/kg/day given orally) in the following ways: dapsone (25 mg/kg/day) or co-trimoxazole (25 mg of sulfamethoxazole plus 5 mg of trimethoprim per kg/day) had no significant effect on ATQ, azithromycin (200 mg/kg/day) or clarithromycin (200 mg/kg/day) had a slight additive effect with ATQ, trimethoprim (100 mg/kg/day) or PS-15 (5 mg/kg/day) had an additive effect with ATQ, and proguanil (25 mg/kg/day) or rifabutin (200 mg/kg/day) had a marked synergistic effect on ATQ."( Effect of atovaquone and atovaquone drug combinations on prophylaxis of Pneumocystis carinii pneumonia in SCID mice.
Comley, JC; Sterling, AM, 1995
)
0.29
" Each dosage group consisted of 10 mice."( Successful treatment of Pneumocystis carinii Pneumonia in mice with benanomicin A (ME1451).
Kitada, K; Komuro, K; Kondo, S; Nakamura, Y; Oka, S; Shibahara, S; Shimada, K; Shimizu, H; Takeuchi, T; Yasuoka, A, 1995
)
0.29
" Intermittent dosing and supplementation with leucovorin have been tried in attempts to improve tolerance."( The tolerance for zidovudine plus thrice weekly or daily trimethoprim-sulfamethoxazole with and without leucovorin for primary prophylaxis in advanced HIV disease. California Collaborative Treatment Group.
Bozzette, SA; Forthal, D; Kemper, C; Leedom, J; McCutchan, JA; Richman, DD; Sattler, FR; Tilles, JG, 1995
)
0.29
" Clinical toxicity, such as headache and gastrointestinal distress, accounted for the observed difference in tolerance between dosing regimens."( The tolerance for zidovudine plus thrice weekly or daily trimethoprim-sulfamethoxazole with and without leucovorin for primary prophylaxis in advanced HIV disease. California Collaborative Treatment Group.
Bozzette, SA; Forthal, D; Kemper, C; Leedom, J; McCutchan, JA; Richman, DD; Sattler, FR; Tilles, JG, 1995
)
0.29
" Leucovorin use does not improve tolerance for chronic TMP/SMX dosing in AIDS, even among patients taking tablets daily."( The tolerance for zidovudine plus thrice weekly or daily trimethoprim-sulfamethoxazole with and without leucovorin for primary prophylaxis in advanced HIV disease. California Collaborative Treatment Group.
Bozzette, SA; Forthal, D; Kemper, C; Leedom, J; McCutchan, JA; Richman, DD; Sattler, FR; Tilles, JG, 1995
)
0.29
"160 children with an average age of 9 years (range 6-15) affected by acute bacterial tonsillitis, were selected and assigned, following an open, parallel group design to: a) brodimoprim at the dose of 10 mg/kg on the first day, in single administration, and of 5 mg/kg on the following days; b) cotrimoxazole suspension, at the dosage of 6 mg of trimethoprim/kg/day, in two daily administrations; c) amoxicillin with clavulanic acid suspension (amoxi-clavulanate) 50 mg/kg every 12 hours."( Efficacy and tolerability of brodimoprim in pharyngotonsillitis in children.
Dallari, S; Galetti, G, 1993
)
0.29
"The results indicate that the pharmacokinetics of SMX in trauma patients differ significantly from nontrauma patients, which may result in lower than expected concentrations using standard dosing guidelines."( Trimethoprim-sulfamethoxazole pharmacokinetics in trauma patients.
Boucher, BA; Croce, MA; Fabian, TC; Hess, MM; Janning, SW; Laizure, SC; Sanders, PL; Stevens, RC,
)
0.13
" Clinical trials are indicated to evaluate this dosing scheme, which may decrease exposure to potentially excessive concentrations of trimethoprim and sulfamethoxazole."( Multiple-dose pharmacokinetics of 12 milligrams of trimethoprim and 60 milligrams of sulfamethoxazole per kilogram of body weight per day in healthy volunteers.
Laizure, SC; Sanders, PL; Stein, DS; Stevens, RC, 1993
)
0.29
" If aerosol pentamidine is used and administered via a Respigard II Marquest nebulizer, the dosage should be higher than the currently recommended monthly dosage of 300 mg."( The role of aerosol pentamidine prophylaxis.
Ong, EL,
)
0.13
" Nonetheless, in light of altered pharmacokinetics in the cystic fibrosis population, appropriate dosage and monitoring parameters for a number of antibiotics have been determined."( Optimisation of antibiotic therapy in cystic fibrosis patients. Pharmacokinetic considerations.
Bosso, JA; Lindsay, CA, 1993
)
0.29
"To determine the effect of multiple dosing of combined sulfamethoxazole and trimethoprim on the single-dose pharmacokinetics of lamivudine."( Pharmacokinetics of lamivudine administered alone and with trimethoprim-sulfamethoxazole.
Eron, JJ; Hussey, EK; Martin, D; Moore, KH; Mydlow, PK; Raasch, RH; Yuen, GJ, 1996
)
0.29
"Coadministration of a single dose of lamivudine and trimethoprim-sulfamethoxazole after daily dosing for 5 days altered the pharmacokinetics of lamivudine."( Pharmacokinetics of lamivudine administered alone and with trimethoprim-sulfamethoxazole.
Eron, JJ; Hussey, EK; Martin, D; Moore, KH; Mydlow, PK; Raasch, RH; Yuen, GJ, 1996
)
0.29
" Tmax of SMX after nipple-bucket dosing was about 40 min shorter than that after catheter dosing."( The effect of reflex closure of the esophageal groove on bioavailability of oral sulfamethoxazole-trimethoprim in ruminating calves.
Hayama, T; Nishida, Y; Oda, K; Takahashi, Y, 1996
)
0.29
" Prednisone therapy was continued until the patient was discharged on hospital day 5, at which time the dosage was tapered."( Reversal of erythema multiforme major with cyclophosphamide and prednisone.
Cole, GW; Eastham, JH; Gómez, MF; Segal, JL, 1996
)
0.29
" carinii pneumonia reported to date in methotrexate-treated rheumatoid arthritis patients demonstrated a number of characteristics: the rheumatoid arthritis was of recent onset in some cases (a few months in one patient); lymphopenia was present in two thirds of cases; one-third of patients were not receiving corticosteroid therapy; the dosage and duration of methotrexate therapy varied widely, from 5 to 30 mg per week and two to 48 months; and four patients died."( Pneumocystis carinii pneumonia in rheumatoid arthritis patients treated with methotrexate. A report of two cases.
Cortet, B; Delcambre, B; Duquesnoy, B; Flipo, RM; Lafitte, JJ; Roux, N; Tonnel, AB, 1996
)
0.29
" An evaluation of the severity of allergic reaction can be used to determine the type of dosing regimen."( Trimethoprim/sulfamethoxazole desensitization.
Cortese, LM; Endy, TP; Soucy, DM, 1996
)
0.29
" This case represents the second report in which a patient experienced TMP/SMX-induced hypoglycemia that resolved after the dosage was adjusted for the patient's decreased renal function."( Trimethoprim/sulfamethoxazole-induced hypoglycemia in a patient with acute renal failure.
Lee, AJ; Maddix, DS, 1997
)
0.3
" Patients with these risk factors should be monitored closely and, more importantly, initiated on a dosing regimen adjusted for renal impairment."( Trimethoprim/sulfamethoxazole-induced hypoglycemia in a patient with acute renal failure.
Lee, AJ; Maddix, DS, 1997
)
0.3
" These results permit dosage individualization adjusted to body weight and renal function to achieve chosen serum level peak and trough goals."( A population pharmacokinetic model of trimethoprim in patients with pneumocystis pneumonia, made with parametric and nonparametric methods.
Gomis, P; Jelliffe, RW; Ruskin, J; Sattler, FR; Tahani, B, 1997
)
0.3
" Fourteen patients with a definite history of adverse reactions to co-trimoxazole on standard PCP prophylactic dosage were selected for desensitization using a regimen of gradual incremental exposure over an 11-day period."( Co-trimoxazole desensitization in HIV-seropositive patients.
Holmes, D; McLean, KA; Rodgers, M; Theodore, CM, 1998
)
0.3
" Ciprofloxacin is better in terms of dosage schedule, duration of treatment, and low cost."( A comparative study of therapeutic response of patients with clinical chancroid to ciprofloxacin, erythromycin, and cotrimoxazole.
D'Souza, P; Khanna, N; Misra, RS; Pandhi, RK; Rattan, A, 1998
)
0.3
" Patients were randomly assigned on a 2:1 basis co-trimoxazole (n=398) or amoxycillin (n=197) in standard WHO doses and dosing schedules, and were monitored in study wards."( Antimicrobial resistance and clinical effectiveness of co-trimoxazole versus amoxycillin for pneumonia among children in Pakistan: randomised controlled trial. Pakistan Co-trimoxazole Study Group.
Kundi, Z; Nomani, NK; Qazi, SA; Schwartz, B; Straus, WL, 1998
)
0.3
" Dosing or frequency of TMP-SMX did not seem to influence risk of chemoprophylaxis failure."( Pneumocystis carinii pneumonia incidence and chemoprophylaxis failure in ambulatory HIV-infected patients. HIV Outpatient Study (HOPS) Investigators.
Holmberg, SD; Moorman, AC; Palella, FJ; Von Bargen, JC, 1998
)
0.3
" In the chronic cystogenic murine models, the combination TMP plus SMX administered from day 5 for 15 days or from day 28 for 288 days, gave protection and even apparent toxoplasmal eradication ('cure') at the highest dosing (60/300 mg/kg per day)."( Evaluation of trimethoprim and sulphamethoxazole as monotherapy or in combination in the management of toxoplasmosis in murine models.
Dumas, JL; Pechère, JC; Pizzolato, G, 1999
)
0.3
" There is no apparent reason to change the dosing regimen of prophylactic co-trimoxazole when there is clinical evidence of damage to the gastrointestinal mucosa induced by chemotherapy."( Gastrointestinal damage induced by cytostatic treatment does not affect the bioavailability of co-trimoxazole.
Höglund, P; Johnsson, A; Ljungberg, B; Nilsson-Ehle, I; Nyhlén, A,
)
0.13
" Dapsone prophylaxis at this dosage is associated with significantly higher rates of PCP than is TMP-SMZ after allogeneic marrow transplantation."( High rates of Pneumocystis carinii pneumonia in allogeneic blood and marrow transplant recipients receiving dapsone prophylaxis.
Boeckh, M; Crawford, SW; Flowers, ME; Gooley, TA; Souza, JP, 1999
)
0.3
" Daily trimethoprim-sulfamethoxazole may offer advantages as a first choice for PCP prophylaxis; thrice-weekly dosing is an appropriate option for patients intolerant of the daily dose."( A randomized trial of daily and thrice-weekly trimethoprim-sulfamethoxazole for the prevention of Pneumocystis carinii pneumonia in human immunodeficiency virus-infected persons. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA)
Abrams, D; Caras, S; Crane, L; El-Sadr, WM; Hafner, R; John, SL; Labriola, A; Luskin-Hawk, R; Pulling, C; Sherer, R; Walker, J; Yurik, TM, 1999
)
0.3
" During a long-term dosing phase, a subset of subjects were evaluated for an interaction between atovaquone and trimethoprim-sulfamethoxazole (TMP-SMX)."( Atovaquone suspension in HIV-infected volunteers: pharmacokinetics, pharmacodynamics, and TMP-SMX interaction study.
Bechtel, C; Davey, RT; Falloon, J; Kovacs, JA; LaFon, SW; Lane, HC; Masur, H; Piscitelli, SC; Polis, MA; Sadler, B; Sargent, S; Walker, RE, 1999
)
0.3
" We recommended TMP-SMX as the first line treatment for pneumonia in CAR because of its low cost, ease of dosing and activity against malaria."( Antimicrobial resistance of nasopharyngeal isolates of Streptococcus pneumoniae and Haemophilus influenzae from children in the Central African Republic.
Deming, MS; Klugman, KP; Ndoyo, J; Rolka, D; Rolka, H; Rowe, AK; Schwartz, B; Wasas, A, 2000
)
0.31
"0 mg of sulphamethoxazole in pure and dosage forms."( Indirect potentiometric titration of sulphamethoxazole in the presence of trimethoprim in co-trimazole tablets using copper based mercury film electrode.
Abdul Kamal Nazer, M; Riyazuddin, P; Shabeer, TK, 2001
)
0.31
" Overall results from these studies indicate patients who are eligible for PCP prophylaxis should be advised to take double-strength trimethoprim/sulfamethoxazole (TMP/SMX) on a daily basis, a dosage found more effective than thrice-weekly."( Optimizing PCP therapy.
Cadman, J; Torres, G, 1997
)
0.3
" In conclusion, CTX at the dosage employed for primary PCP/TE prophylaxis does not seem to protect against bacterial infections more than second-line DP."( Incidence and determinants of bacterial infections in HIV-positive patients receiving anti-Pneumocystis carinii/Toxoplasma gondii primary prophylaxis within a randomized clinical trial.
Ammassari, A; Antinori, A; Cingolani, A; De Luca, A; Grillo, R; Murri, R; Pallavicini, F; Pezzotti, P, 2001
)
0.31
" To ascertain the per square meter (m2) dosage each child was receiving, body surface area was calculated from height and weight measurements."( Successful prophylaxis against Pneumocystis carinii pneumonia in HIV-infected children using smaller than recommended dosages of trimethoprim-sulfamethoxazole.
Fisher, RG; McKinney, RE; Nageswaran, S; Valentine, ME, 2001
)
0.31
" This hematologic adverse effect of TMP/SMX may occur even with the usual recommended dosage and duration of therapy."( Severe thrombocytopenia possibly associated with TMP/SMX therapy.
Fosnocht, BJ; Weixelman, JM; Yamreudeewong, W, 2002
)
0.31
" Two dosing regimens of TMP-SMX were investigated: TMP-SMX 8 mg (TMP)/kg/day and TMP-SMX 15 mg/kg/day, each divided into two doses/day Both dosages were studied against each strain in a two-compartment in vitro model to determine concentration-related activity."( Trimethoprim-sulfamethoxazole activity and pharmacodynamics against glycopeptide-intermediate Staphylococcus aureus.
Chen, DC; Close, SJ; Garvin, CG; Martin, SJ; McBurney, CR, 2002
)
0.31
" The treatment was effective, and the dosage of predonisolone had been gradually tapered."( [A case of Nocardia farcinica pneumonia treated with sulfamethoxazole-trimethoprim monitoring its serum concentration].
Gotou, H; Igarashi, H; Kachi, S; Kawai, S; Kobayashi, H; Nakazato, Y; Ochi, M; Sekine, H; Takeda, H; Tashimo, Y; Watanabe, H, 2002
)
0.31
"Results suggest that administration of trimethoprim-sulfamethoxazole at a dosage of 26."( Effects of short-term trimethoprim-sulfamethoxazole administration on thyroid function in dogs.
Frank, LA; Hnilica, KA; Williamson, NL, 2002
)
0.31
"To identify and assess differences in the rationality of cotrimoxazole prescription by DDs and NDDs evaluated by drug choice and dosage in relation to diagnoses and symptoms."( Cotrimoxazole prescribing by dispensing and non-dispensing doctors: do they differ in rationality?
Hansen, EH; Trap, B, 2002
)
0.31
" Antibiotic levels in the mice were determined by HPLC, and dosing was modified to keep plasma antibiotic levels at or above the MIC for the organism-antibiotic combination for a significant part of a 12 h period."( A comparison of antibiotic regimens in the treatment of acute melioidosis in a mouse model.
Bowden, B; Hirst, R; Norton, R; Powell, K; Ulett, GC, 2003
)
0.32
" Many of the fluoroquinolone agents have once-daily dosing regimens, enhancing patient adherence."( The expanding role of fluoroquinolones.
Schaeffer, AJ, 2003
)
0.32
" This association extended to exposure to other antimicrobial drugs in addition to trimethoprim-sulfamethoxazole and the overall association displayed a dose-response relationship in terms of the number of prior drug exposures."( Prior antimicrobial drug exposure: a risk factor for trimethoprim-sulfamethoxazole-resistant urinary tract infections.
Asch, DA; Metlay, JP; Strom, BL, 2003
)
0.32
" brasiliensis with well-preserved morphology and abundant budding, whereas SXT-treated mice, independently of the dosage used, had no granulomas within the parenchyma and only few capsular lesions, mainly composed of pseudoxantomatous macrophages."( Paracoccidioidomycosis: reduction in fungal load and abrogation of delayed-type hypersensitivity anergy in susceptible inbred mice submitted to therapy with trimethoprim-sulfamethoxazole.
Burger, E; Scavone, R, 2004
)
0.32
" Steps should be taken to educate physicians and patients on the choice and dosage of antibiotics for cystitis to minimize emergence of antibiotic resistance."( Antibiotic prescribing for cystitis: how well does it match published guidelines?
Farjo, R; Foxman, B; McEwen, LN, 2003
)
0.32
"To evaluate the efficacy of two dosing regimens of cotrimoxazole in the treatment of falciparum malaria and compare the efficacy with that of chloroquine, the first-line antimalaria drug in the area of study."( Comparative efficacy of chloroquine and cotrimoxazole in the treatment of acute uncomplicated falciparum malaria in Nigerian children.
Adedeji, AA; Fehintola, FA; Sowunmi, A,
)
0.13
" The use of antibiotics with favourable pharmacokinetic/pharmacodynamic profiles and convenient dosing schedules, which effectively increase bacterial eradication and patient compliance, can help to curb the current epidemic of resistance and reduce the rate of clinical failure associated with resistance."( Extended-release ciprofloxacin (Cipro XR) for treatment of urinary tract infections.
Elkharrat, D; Naber, KG; Palou, J; Talan, DA, 2004
)
0.32
" Information regarding absorption, excretion and dosing was also gathered to explain better the mechanisms of toxicity."( Adverse reactions of nitrofurantoin, trimethoprim and sulfamethoxazole in children.
Karpman, E; Kurzrock, EA, 2004
)
0.32
" Penicillin nonsusceptibility is found in nearly 40% of strains causing disease in adults, although often these cases are treatable with appropriate dosing regimens of many oral and parenteral beta-lactam agents."( Streptococcus pneumoniae: epidemiology and patterns of resistance.
Jacobs, MR, 2004
)
0.32
" The applied dosage was often lower than suggested in the literature."( [The use of sulfonamides and sulfonamide/trimethoprim combinations as animal feed drugs for pigs in Schleswig-Holstein].
Bettin, U; Broll, S; Kietzmann, M; Kreienbrock, L,
)
0.13
" The obtained three dissolution profiles from one dosage form are the whole formulation profile or "global profile" recommended by pharmacopoeias, and, at same time, are recorded two "individual" profiles from two drugs present in the formulation."( Automated simultaneous triple dissolution profiles of two drugs, sulphamethoxazole-trimethoprim and hydrochlorothiazide-captopril in solid oral dosage forms by a multicommutation flow-assembly and derivative spectrophotometry.
Catalá Icardo, M; Martínez Calatayud, J; Tomsů, D, 2004
)
0.32
" We compared the clinical efficacy of twice-daily cotrimoxazole in standard versus double dosage for treating non-severe pneumonia in children."( Randomized controlled trial of standard versus double dose cotrimoxazole for childhood pneumonia in Pakistan.
Azam, I; Aziz, F; Bano, N; Bari, A; Hussain, W; Iqbal, I; Khan, M; Khan, S; Nagi, AG; Qazi, S; Rafi, S; Rasmussen, ZA; Rehman, G; Roghani, MT; van Latum, LJ, 2005
)
0.33
"Results suggest that administration of T/SMX at a dosage of 14."( Effects of sulfamethoxazole-trimethoprim on thyroid function in dogs.
Davis, JA; Frank, LA; Hnilica, KA; May, ER; Sargent, SJ, 2005
)
0.33
" On day 4 after dosing completion, the mice were infected intratracheally with 1x10(7) Pneumocystis murina organisms."( Combination exposure to zidovudine plus sulfamethoxazole-trimethoprim diminishes B-lymphocyte immune responses to Pneumocystis murina infection in healthy mice.
Feola, DJ; Garvy, BA, 2006
)
0.33
" Dosage adjustments should be made when prescribing co-trimoxazole to patients with renal dysfunction."( Severe and protracted hypoglycaemia associated with co-trimoxazole use.
Gold, WL; Kuper, A; Strevel, EL, 2006
)
0.33
"Thirty-four privately owned sulphonamide HS dogs, 10 sulphonamide-'tolerant' dogs, 18 sulphonamide-naïve dogs, and four dogs experimentally dosed with SMX and the oxidative metabolite SMX-nitroso, were tested for drug-serum adducts by immunoblotting, and anti-drug antibodies by ELISA."( Association of drug-serum protein adducts and anti-drug antibodies in dogs with sulphonamide hypersensitivity: a naturally occurring model of idiosyncratic drug toxicity.
Danhof, RS; Lavergne, SN; Trepanier, LA; Volkman, EM, 2006
)
0.33
" Anti-drug antibodies were also found in dogs experimentally dosed with SMX-nitroso followed by SMX, but not in a dog dosed with drug vehicle, followed by SMX."( Association of drug-serum protein adducts and anti-drug antibodies in dogs with sulphonamide hypersensitivity: a naturally occurring model of idiosyncratic drug toxicity.
Danhof, RS; Lavergne, SN; Trepanier, LA; Volkman, EM, 2006
)
0.33
" Urine samples were taken every 2 h during the whole dosing interval of the particular antibiotic."( Urinary bactericidal activity of oral antibiotics against common urinary tract pathogens in an ex vivo model.
Bedenic, B; Bubonja, M; Budimir, A; Topic, M, 2006
)
0.33
"This study used a single-dose, randomized,single-blind, 2 x 2 crossover (2 dosing periods x 2 treatments) design to compare the 2 preparations."( Bioequivalence of two commercial preparations of trimethoprim/sulfamethoxazole: a randomized, single-dose, single-blind, crossover trial.
Alonso Campero, R; Bernardo Escudero, R; Burke Fraga, V; De Lago Acosta, A; Del Cisne Valle Alvarez, D; González de la Parra, M; Namur Montalvo, S; Silva Hernandez, R, 2007
)
0.34
"This study was conducted to determine the efficacy of dosing trimethoprim/sulfamethoxazole on 2 consecutive days per week for the prevention of Pneumocystis carinii (jiroveci) pneumonia in a pediatric leukemia and lymphoma population and to determine whether trimethoprim/sulfamethoxazole contributes to neutropenia during maintenance therapy."( Successful intermittent prophylaxis with trimethoprim/sulfamethoxazole 2 days per week for Pneumocystis carinii (jiroveci) pneumonia in pediatric oncology patients.
Albano, E; Lindemulder, S, 2007
)
0.34
" A total of 482 (345 leukemia, 137 lymphoma) patients were evaluated on trimethoprim/sulfamethoxazole dosed 2 consecutive days per week for 268074 patient-days."( Successful intermittent prophylaxis with trimethoprim/sulfamethoxazole 2 days per week for Pneumocystis carinii (jiroveci) pneumonia in pediatric oncology patients.
Albano, E; Lindemulder, S, 2007
)
0.34
" According to current guidelines, the dosage of the drug was too high in both cases."( [Serious side effects of frequently used antibiotics in childhood: biliary sludge or stones induced by ceftriaxone and thrombocytopenia induced by co-trimoxazole].
Landstra, AM; Maseland, MH; van Setten, PA; Voeten, M, 2007
)
0.34
" At 5 ART sites, CTX was given to patients dosed at 960 mg daily or 480 mg twice a day (according to national guidelines)."( Lower early mortality rates among patients receiving antiretroviral treatment at clinics offering cotrimoxazole prophylaxis in Malawi.
Aberle-Grasse, J; Eiger, O; Ellerbrock, T; Harries, A; Libamba, E; Lowrance, D; Makombe, S; Marston, B; Shiraishi, R; Yu, J, 2007
)
0.34
" no change in warfarin dosing in 40 chronically anticoagulated patients initiating trimethoprim-sulfamethoxazole (TMP-SMX) or levofloxacin."( Impact of preemptive warfarin dose reduction on anticoagulation after initiation of trimethoprim-sulfamethoxazole or levofloxacin.
Ahmed, A; Fay, WP; Kaus, CA; Stephens, JC, 2008
)
0.35
" An expectant strategy consisting of no change in warfarin dosing with short-term INR follow-up appears reasonable in patients treated with levofloxacin."( Impact of preemptive warfarin dose reduction on anticoagulation after initiation of trimethoprim-sulfamethoxazole or levofloxacin.
Ahmed, A; Fay, WP; Kaus, CA; Stephens, JC, 2008
)
0.35
" Current recommendations for trimethoprim-sulfamethoxazole (TMP-SMZ) dosing as PCP prophylaxis in immunocompromised patients are based on either daily dosing or dosing three consecutive days per week."( Intermittent oral trimethoprim/sulfamethoxazole on two non-consecutive days per week is effective as Pneumocystis jiroveci pneumonia prophylaxis in pediatric patients receiving chemotherapy or hematopoietic stem cell transplantation.
Hara, J; Hashii, Y; Ohata, Y; Ohta, H; Ozono, K; Tokimasa, S, 2009
)
0.35
" A pharmacokinetic (PK) simulation study was performed to determine the optimal dosing of cotrimoxazole (trimethoprim-sulfamethoxazole [TMP-SMX]) used in current eradication regimens in Thailand and Australia."( Dosing regimens of cotrimoxazole (trimethoprim-sulfamethoxazole) for melioidosis.
Amornchai, P; Cheng, AC; Chierakul, W; Day, NP; McBryde, ES; Peacock, SJ; White, NJ; Wuthiekanun, V, 2009
)
0.35
" This discrepancy may be explained by the subtherapeutic dosage used in the pharmacokinetic study."( Symptomatic hypoglycemia associated with trimethoprim/sulfamethoxazole and repaglinide in a diabetic patient.
Blondel, E; Fonrose, X; Mallaret, MP; Roustit, M; Villier, C, 2010
)
0.36
" When dosing was considered, the association was greater at higher doses of TMP-SMX."( Beta-blockers, trimethoprim-sulfamethoxazole, and the risk of hyperkalemia requiring hospitalization in the elderly: a nested case-control study.
Garg, AX; Gomes, T; Hackam, DG; Jain, AK; Juurlink, DN; Mamdani, M; Weir, MA, 2010
)
0.36
"Data on TMP and SMX pharmacokinetics in CVVHDF are lacking and dosing recommendations are inconclusive."( Trimethoprim/Sulfamethoxazole pharmacokinetics in two patients undergoing continuous venovenous hemodiafiltration.
Ceschi, A; Corti, N; Curkovic, I; Franzen, D; Lüthi, B; Rudiger, A, 2010
)
0.36
" Evidence of in vivo synergy could lead to a reduction of the standard VAN dosage or treatment time."( Evaluation of the synergistic potential of vancomycin combined with other antimicrobial agents against methicillin-resistant Staphylococcus aureus and coagulase-negative Staphylococcus spp strains.
Araújo, MT; Nunes, AP; Santos, KR; Silva, LV, 2011
)
0.37
" Physician should bear in mind the potential trimethoprim-sulfamethoxazole-associated adverse event especially when prolonged treatments and elevated dosage are used."( Trimethoprim-sulfamethoxazole-associated severe hypoglycaemia: a sulfonylurea-like effect.
Bellissimo, F; Benanti, F; Cacopardo, B; Caltabiano, E; Celesia, BM; Giarratana, F; La Rocca, M; Nunnari, G; Russo, R; Tosto, S, 2010
)
0.36
" Medical records of CTD patients who were treated with prednisolone ≥20 mg per day or equivalent doses of corticosteroid for more than 2 weeks and were followed for at least 12 weeks after receiving this dosage of corticosteroids at the Rheumatology clinic of Ramathibodi Hospital between October 2006 and September 2007 were reviewed."( Primary prophylaxis for Pneumocystis jirovecii pneumonia in patients with connective tissue diseases.
Janwityanujit, S; Limsuwan, T; Ngamjanyaporn, P; Sungkanuparph, S; Suwannalai, P; Vananuvat, P, 2011
)
0.37
" All patients on prophylaxis were using cotrimoxazole, with the 960 mg once daily dosing being the most common regimen (96%)."( Use of cotrimoxazole prophylaxis in HIV infected in patients at a referral hospital.
Bulaya-Tembo, R; Khoza, S; Mkudu, V; Mthethwa, J; Nhachi, CF,
)
0.13
" A combination of daptomycin plus trimethoprim/sulfamethoxazole (TMP/SMX) was administered for six weeks, followed by a high dosage of TMP/SMX for a further six weeks."( High dose of trimethoprim-sulfamethoxazole and daptomycin as a therapeutic option for MRSA endocarditis with large vegetation complicated by embolic stroke: a case report and literature review.
Bonura, C; D'Alessandro, N; Di Carlo, P; Giarratano, A; Guadagnino, G; Lunetta, M; Mammina, C; Novo, S, 2013
)
0.39
" Pharmacokinetic studies for TMP/SMX dosing in this patient population are necessary to allow adequate dosing."( Cotrimoxazole plasma levels, dialyzer clearance and total removal by extended dialysis in a patient with acute kidney injury: risk of under-dosing using current dosing recommendations.
Beutel, G; Clajus, C; Kielstein, JT; Kühn-Velten, WN; Lorenzen, JM; Pietsch, D; Schmidt, JJ, 2013
)
0.39
"5) understood the reason for CTX prophylaxis, 126 (47%) did not dose during weekends; 55 (21%) dosed their infants 3 times a day and 70 (26%) dosed their infants twice daily."( Factors associated with coverage of cotrimoxazole prophylaxis in HIV-exposed children in South Africa.
Mahungo, W; Masha, R; Moodley, D; Reddy, L, 2013
)
0.39
" SJS can occur in children at any age, with any level of immunosuppression, and can occur during the lead-in dosing period of NVP."( Stevens-Johnson syndrome and HIV in children in Swaziland.
Blank, DA; Draper, HR; Dziuban, EJ; Hughey, AB; Kochelani, D; Schutze, GE; Stewart, DA, 2013
)
0.39
"Between 2002 and 2010, 22 patients received two tablets of co-trimoxazole three times a day, equivalent to a daily dosage of 2400 mg of sulfamethoxazole and 480 mg of trimethoprim."( Serum concentration of co-trimoxazole during a high-dosage regimen.
Drancourt, M; Le Poullain, MN; Muhammed Ameen, S; Raoult, D; Rolain, JM; Roux, V, 2014
)
0.4
" pneumoniae strains tested were penicillin resistant, standard penicillin dosing for pneumonia may be insufficient given the observed range of pneumococcal penicillin MICs."( Antimicrobial susceptibility of Streptococcus pneumoniae in adult patients with pneumococcal pneumonia in an urban hospital in Mozambique.
Beishuizen, SJ; Bos, JC; Cossa, EO; Gomonda, Edos S; Macome, AC; Madeira, GC; Prins, JM; Schultsz, C; van Steenwijk, RP, 2014
)
0.4
" Moreover, although we based the dosage of cranberry extract on available evidence, this may not be the optimal dosage."( Cost-effectiveness of cranberries vs antibiotics to prevent urinary tract infections in premenopausal women: a randomized clinical trial.
Beerepoot, MA; Bosmans, JE; Geerlings, SE; Prins, JM; ter Riet, G, 2014
)
0.4
" However this knowledge does not extend to understanding of proper therapeutic indications and dosage regimens for antibiotic therapy."( How much do patients in Blantyre, Malawi know about antibiotics and other prescription only medicines?
Bandawe, CR; Foster, EK, 2014
)
0.4
"Study participants had wide range of knowledge about antibiotics and other POM from hospital, but the majority had limited knowledge regarding clinical indications and correct dosage schedules."( How much do patients in Blantyre, Malawi know about antibiotics and other prescription only medicines?
Bandawe, CR; Foster, EK, 2014
)
0.4
" However, the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs."( Protective efficacy and safety of three antimalarial regimens for the prevention of malaria in young Ugandan children: a randomized controlled trial.
Achan, J; Aweeka, FT; Bigira, V; Clark, TD; Dorsey, G; Havlir, DV; Huang, L; Kamya, MR; Kapisi, J; Kinara, S; Muhindo, MK; Mwangwa, F; Osterbauer, B; Rosenthal, PJ, 2014
)
0.4
" Diagnosis can be confirmed with drug challenge or graded test dosing when necessary."( Trimethoprim-sulfamethoxazole-induced aseptic meningitis-not just another sulfa allergy.
Bruner, KE; Coop, CA; White, KM, 2014
)
0.4
"We conclude that anti-MRSA antibiotics are utilized via various dosage regimens by a majority of CF Foundation accredited care programs for the treatment of chronic MRSA in PEx, and there is no consensus on the best treatment approach."( Utilization of antibiotics for methicillin-resistant Staphylococcus aureus infection in cystic fibrosis.
Ampofo, K; Chin, MJ; Dasenbrook, E; Epps, KL; Marshall, BC; Montague, M; Olson, J; Young, DC; Zobell, JT, 2015
)
0.42
" Optimal dosing regimens in solid-organ transplant recipients have not been fully defined."( Tolerability of low-dose sulfamethoxazole/trimethoprim for Pneumocystis jirovecii pneumonia prophylaxis in kidney transplant recipients.
Cardwell, SM; Martin, ST; Nailor, MD; Zmarlicka, M, 2015
)
0.42
" In 2005, the University of Kentucky (UK) Transplant Center implemented a novel dosing regimen of weekly dapsone as an alternative for patients with contraindications or intolerability to trimethoprim-sulfamethoxazole (TMP-SMZ), which remains the drug of choice."( Efficacy of once-weekly dapsone dosing for Pneumocystis jirovecii pneumonia prophylaxis post transplantation.
Au, T; Clifford, TM; Evans, RA; Fugit, AM; Tang, S, 2015
)
0.42
" Future studies are warranted to show the efficacy of weekly dapsone dosing compared to other PCP prophylaxis regimens."( Efficacy of once-weekly dapsone dosing for Pneumocystis jirovecii pneumonia prophylaxis post transplantation.
Au, T; Clifford, TM; Evans, RA; Fugit, AM; Tang, S, 2015
)
0.42
" The aim of this study was to assess whether appropriate dosage adjustments were made in hospitalized patients with renal impairment."( Drug dosage adjustment in hospitalized patients with renal impairment at Tikur Anbessa specialized hospital, Addis Ababa, Ethiopia.
Getachew, H; Shibeshi, W; Tadesse, Y, 2015
)
0.42
" Data regarding serum creatinine level, age, sex and prescribed drugs and their dosage was collected from the patients' medical records."( Drug dosage adjustment in hospitalized patients with renal impairment at Tikur Anbessa specialized hospital, Addis Ababa, Ethiopia.
Getachew, H; Shibeshi, W; Tadesse, Y, 2015
)
0.42
"The findings indicate that dosing errors were common among hospitalized patients with renal impairment."( Drug dosage adjustment in hospitalized patients with renal impairment at Tikur Anbessa specialized hospital, Addis Ababa, Ethiopia.
Getachew, H; Shibeshi, W; Tadesse, Y, 2015
)
0.42
" Charts were reviewed to determine the effect of age, risk behaviors, severity of illness, viral load, CD4 cell counts, use of corticosteroids, and dosage and duration of TMP/SMX on ADRs during hospitalization."( High daily doses of trimethoprim/sulfamethoxazole are an independent risk factor for adverse reactions in patients with pneumocystis pneumonia and AIDS.
Chang, HM; Chen, YS; Kunin, C; Lee, SS; Lin, PC; Tsai, HC; Wann, SR, 2016
)
0.43
" The dosage of co-trimoxazole significantly correlated with survival."( Efficacy of concurrent treatments in idiopathic pulmonary fibrosis patients with a rapid progression of respiratory failure: an analysis of a national administrative database in Japan.
Fujino, Y; Fushimi, K; Hanaka, T; Ishimoto, H; Kido, T; Matsuda, S; Mukae, H; Nakao, H; Oda, K; Ogoshi, T; Yatera, K, 2016
)
0.43
"Irrespective of the dosage of VRCZ, eight patients developed IFI."( Prophylactic administration of voriconazole with two different doses for invasive fungal infection in children and adolescents with acute myeloid leukemia.
Hori, D; Kishimoto, K; Kobayashi, K; Kobayashi, R; Sano, H; Suzuki, D; Yasuda, K, 2018
)
0.48
" Further refinement of artemether-lumefantrine dosing to improve exposure in infants and very young children may be warranted."( Population Pharmacokinetics and Pharmacodynamics of Lumefantrine in Young Ugandan Children Treated With Artemether-Lumefantrine for Uncomplicated Malaria.
Arinaitwe, E; Aweeka, FT; Bergqvist, Y; Bigira, V; Blessborn, D; Creek, DJ; Kakuru, A; McCormack, SA; Muhindo, M; Parikh, S; Sambol, NC; Sukumar, N; Tappero, JW; Tchaparian, E; Wanzira, H, 2016
)
0.43
" Dosing is inconsistently based on weight, assuming linear relationships."( Fractal Geometry-Based Decrease in Trimethoprim-Sulfamethoxazole Concentrations in Overweight and Obese People.
Gumbo, T; Hall, RG; Leff, RD; Meek, C; Pasipanodya, JG; Swancutt, M, 2016
)
0.43
"6 mg/kg/day were randomized into three dosage groups: a single-strength group (SS, SMX/TMP of 400/80 mg daily), half-strength group (HS, 200/40 mg daily), and escalation group (ES, started with 40/8 mg daily, increasing incrementally to 200/40 mg daily)."( Optimal regimens of sulfamethoxazole-trimethoprim for chemoprophylaxis of Pneumocystis pneumonia in patients with systemic rheumatic diseases: results from a non-blinded, randomized controlled trial.
Dobashi, H; Hagiyama, H; Harigai, M; Hirano, F; Hirata, S; Kihara, M; Kohsaka, H; Koike, R; Kondo, M; Matsui, K; Miyasaka, N; Nagasaka, K; Nanki, T; Nonomura, Y; Odani, T; Saito, K; Sakai, R; Soejima, M; Sugihara, T; Suzuki, F; Takenaka, K; Tomita, M; Utsunomiya, M; Yamazaki, H; Yokogawa, N; Yokoyama, W, 2017
)
0.46
"Tedizolid is an orally bioavailable oxazolidinone with once-daily dosing and broad-spectrum Gram-positive activity."( Exploring the pharmacodynamic interactions between tedizolid and other orally bioavailable antimicrobials against Staphylococcus aureus and Staphylococcus epidermidis.
Werth, BJ, 2017
)
0.46
" Treatment of these infections requires the use of a higher dosage that may result in increased toxicity or the use of new promising antimicrobials to control the infection."( Old antimicrobials and Gram-positive cocci through the example of infective endocarditis and bone and joint infections.
Amrane, S; Million, M; Seng, P; Stein, A, 2017
)
0.46
" The typically intolerable adverse effects of TMP-SMZ therapy for PJP may necessitate dosage adjustments in some cases."( Combination of Echinocandins and Trimethoprim/Sulfamethoxazole for the Treatment of Pneumocystis jiroveci Pneumonia After Heart Transplantation.
Chang, CY; Chang, HC; Huang, CM; Lee, YT; Lu, YM; Wei, J; Yang, HS, 2017
)
0.46
"This case study illustrates once more the critical importance of prescription appropriateness in elderly patients with multiple morbidities in terms of type and dosage of drugs, in order to avoid serious adverse reactions."( Persistent and severe hypoglycemia associated with trimethoprim-sulfamethoxazole in a frail diabetic man on polypharmacy: A case report and literature review
.
Arcudi, S; Peyvandi, F; Piconi, S; Rossio, R, 2018
)
0.48
" It is essential to assess the clinical application and the dose-response relationships of combinations such as colistin plus cotrimoxazole."( In vivo activity of co-trimoxazole combined with colistin against Acinetobacter baumannii producing OXA-23 in a Galleria mellonella model.
Hefzy, EM; Khalil, MAF; Moawad, SS, 2019
)
0.51
"In this multicenter retrospective study, we compared effectiveness and safety of SMX/TMP for the treatment of PCP among patients divided into three groups according to the initial dosage of SMX/TMP: the low, ≤10 mg/kg/day; the intermediate, 10-15 mg/kg/day; and the high and conventional, 15-20 mg/kg/day for TMP dose."( Effectiveness and safety of lower dose sulfamethoxazole/trimethoprim therapy for Pneumocystis jirovecii pneumonia in patients with systemic rheumatic diseases: A retrospective multicenter study.
Iwagaitsu, S; Kazawa, N; Maeda, S; Miyamoto, T; Naniwa, T; Niimi, A; Ohmura, SI; Shichi, D; Tamechika, SY; Wada, JI, 2019
)
0.51
" Given the side effects and low rates of oral therapy completion in our region we emphasise the importance of the prior often prolonged intensive phase intravenous therapy and using weight based trimethoprim-sulfamethoxazole dosing for eradication therapy."( Oral eradication therapy for melioidosis: Important but not without risks.
Currie, BJ; Sullivan, RP; Ward, L, 2019
)
0.51
" Our model-rederived optimal dosing of TMP at the target tissue was in the range of recommended dosing for TMP-SMX in children in all age groups by current guidelines for the treatment of MRSA."( Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children.
Balevic, SJ; Cobbaert, M; Cohen-Wolkowiez, M; Cunningham, AP; Edginton, AN; Hornik, CP; Maharaj, A; Thompson, EJ; Wu, H, 2019
)
0.51
" A low albumin dosage was identified as a predictor factor for mortality."( Acute-subacute paracoccidioidomycosis: A paediatric cohort of 141 patients, exploring clinical characteristics, laboratorial analysis and developing a non-survival predictor.
Morcillo, AM; Pereira, RM; Romaneli, MTDN; Tardelli, NR; Tresoldi, AT, 2019
)
0.51
" Dosage was 80 mg/400 mg (per tablet), administered as 3 tablets per week for 30."( Impact of Very Low-Dose Trimethoprim-Sulfamethoxazole on Serum Creatinine after Renal Transplantation: A Retrospective Study.
Fujii, M; Hidaka, Y; Inadome, A; Kaba, A; Kashima, M; Kawabata, C; Kinoshita, K; Miyata, A; Ogata, M; Tanaka, K; Toyoda, M; Uekihara, S; Yamanaga, S; Yokomizo, H,
)
0.13
"Our study suggests that the high total dosage of ATG and CMV infection indicate the increased risk of PJP."( The risk factor analysis and treatment experience in pneumocystis jirovecii pneumonia after kidney transplantation.
Cai, R; Liang, W; Yang, P; Zhu, X, 2021
)
0.62
" Half-dosage of TMP-SMX (40/200 mg daily) is considered more tolerable than the conventional dosage (80/400 mg daily)."( Risk factors associated with increased discontinuation rate of trimethoprim-sulfamethoxazole used as a primary prophylaxis for Pneumocystis pneumonia: A retrospective cohort study.
Fujitaka, K; Hamada, H; Hattori, N; Hirata, S; Horimasu, Y; Iwamoto, H; Masuda, T; Miyamoto, S; Nakashima, T; Otani, T; Sakamoto, S; Sugiyama, E; Yamaguchi, K, 2021
)
0.62
" The univariate and multivariate Cox proportional hazards models revealed that the SS dosage and renal function (e."( Risk factors associated with increased discontinuation rate of trimethoprim-sulfamethoxazole used as a primary prophylaxis for Pneumocystis pneumonia: A retrospective cohort study.
Fujitaka, K; Hamada, H; Hattori, N; Hirata, S; Horimasu, Y; Iwamoto, H; Masuda, T; Miyamoto, S; Nakashima, T; Otani, T; Sakamoto, S; Sugiyama, E; Yamaguchi, K, 2021
)
0.62
" In patients with a mild renal impairment, the HS dosage may improve tolerability while maintaining prophylactic efficacy."( Risk factors associated with increased discontinuation rate of trimethoprim-sulfamethoxazole used as a primary prophylaxis for Pneumocystis pneumonia: A retrospective cohort study.
Fujitaka, K; Hamada, H; Hattori, N; Hirata, S; Horimasu, Y; Iwamoto, H; Masuda, T; Miyamoto, S; Nakashima, T; Otani, T; Sakamoto, S; Sugiyama, E; Yamaguchi, K, 2021
)
0.62
" Conversely, escalation dosing or 200 mg/40 mg/day regimens appeared better tolerated."( Is cotrimoxazole prophylaxis against Pneumocystis jirovecii pneumonia needed in patients with systemic autoimmune rheumatic diseases requiring immunosuppressive therapies?
Brito-García, N; Díaz Del Campo Fontecha, P; Nishishinya-Aquino, MB; Pereda, CA; Rua-Figueroa, I, 2021
)
0.62
"Orally disintegrating tablet (ODT) is a dosage form that overcomes the problem of swallowing which is prevalent in about 35% of the general population."( Formulation, in vitro characterization and optimization of taste-masked orally disintegrating co-trimoxazole tablet by direct compression.
Abrha, S; Tafere, C; Yehualaw, A; Yilma, Z, 2021
)
0.62
" The successful formulation of CTX ODT can solve difficulty of swallowing of conventional tablets for some group of patients which are unable to swallow solid oral dosage form."( Formulation, in vitro characterization and optimization of taste-masked orally disintegrating co-trimoxazole tablet by direct compression.
Abrha, S; Tafere, C; Yehualaw, A; Yilma, Z, 2021
)
0.62
" As cystic fibrosis patients present disturbed pharmacokinetics parameters, drug monitoring would be relevant to assess the lung distribution of antibiotics and to optimize dosing regimens."( Determination of amoxicillin and cotrimoxazole concentrations in sputum of patients with cystic fibrosis.
Belleguic, C; Bellissant, E; Brinchault, G; Deneuville, E; Kayal, S; Lemaitre, F; Piau, C; Ricordel, C; Tron, C; Verdier, MC, 2021
)
0.62
" The recommended prophylactic dose of TMP-SMX has been determined based on patients with normal renal function, but the appropriate dosage for patients undergoing hemodialysis is unknown."( Safety and efficacy evaluation of low-dose trimethoprim-sulfamethoxazole for prophylaxis of Pneumocystis pneumonia in HIV uninfected patients undergoing hemodialysis: a retrospective observational study.
Hashida, T; Ikesue, H; Muroi, N; Shimomura, Y; Yamashita, K; Yoshimoto, A, 2021
)
0.62
" These findings can guide health care professionals to determine TMP-SMX dosage when considering PCP prophylaxis for patients undergoing hemodialysis."( Safety and efficacy evaluation of low-dose trimethoprim-sulfamethoxazole for prophylaxis of Pneumocystis pneumonia in HIV uninfected patients undergoing hemodialysis: a retrospective observational study.
Hashida, T; Ikesue, H; Muroi, N; Shimomura, Y; Yamashita, K; Yoshimoto, A, 2021
)
0.62
" The conventional treatment of PJP is sulfamethoxazole-trimethoprim (SMX-TMP) dosed at 15-20 mg/kg/day of the trimethoprim component."( The effectiveness and safety of low dose trimethoprim-sulfamethoxazole for the treatment of pneumocystis pneumonia: A systematic review and meta-analysis.
Hejazi, AA; Timbrook, TT; Tritle, BJ, 2021
)
0.62
" MEDLINE and Embase databases were searched from inception to January 15, 2020, for studies in English evaluating low-dose SMX-TMP (<15 mg/kg/day) compared to conventional dosing for the treatment of PJP."( The effectiveness and safety of low dose trimethoprim-sulfamethoxazole for the treatment of pneumocystis pneumonia: A systematic review and meta-analysis.
Hejazi, AA; Timbrook, TT; Tritle, BJ, 2021
)
0.62
"While one in five children in the USA are now obese, and more than three-quarters receive at least one drug during childhood, there is limited dosing guidance for this vulnerable patient population."( Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling.
Carreño, FO; Cohen-Wolkowiez, M; Edginton, AN; Ganguly, S; Gerhart, JG; Gonzalez, D; Harris, V; Hornik, CP; Kumar, KR; Perrin, EM; Rikhi, A; Sinha, J, 2022
)
0.72
" Relative to children without obesity, children with obesity experienced decreased clindamycin and trimethoprim/sulfamethoxazole weight-normalized clearance and volume of distribution, and higher absolute doses under recommended pediatric weight-based dosing regimens."( Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling.
Carreño, FO; Cohen-Wolkowiez, M; Edginton, AN; Ganguly, S; Gerhart, JG; Gonzalez, D; Harris, V; Hornik, CP; Kumar, KR; Perrin, EM; Rikhi, A; Sinha, J, 2022
)
0.72
"Model simulations support current recommended weight-based dosing in children with obesity for clindamycin and trimethoprim/sulfamethoxazole, as they met target exposure despite these changes in clearance and volume of distribution."( Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling.
Carreño, FO; Cohen-Wolkowiez, M; Edginton, AN; Ganguly, S; Gerhart, JG; Gonzalez, D; Harris, V; Hornik, CP; Kumar, KR; Perrin, EM; Rikhi, A; Sinha, J, 2022
)
0.72
" The rate of healthcare-associated infection after urological surgery using TAP was high, implying to discuss the choice and the dosage of the antibiotic molecules."( Therapeutic failures of targeted antibiotic prophylaxis in urology.
Blanchet, P; Brureau, L; Curlier, E; Donat, S; Markowicz, S; Roger, PM; Sadreux, Y, 2022
)
0.72
"Although there is a lack of data in trimethoprim-sulfamethoxazole (TMP-SMX) serum monitoring utility for invasive nocardial infections, therapeutic drug monitoring is widely used to optimize dosing and avoid adverse reactions that may cause treatment interruption."( Observational study of the clinical utility of sulfamethoxazole serum level monitoring in the treatment of brain abscesses due to Nocardia species.
Abu Saleh, O; Corsini Campioli, C; Mara, KC; Rivera, CG, 2022
)
0.72
"Since trimethoprim (TMP) dose-dependently inhibits the excretion of potassium, a population kinetic-pharmacodynamic analysis was performed to establish an adequate dosing schedule and characterize factors of hyperkalaemia."( Population kinetic-pharmacodynamic analysis of serum potassium in patients receiving sulfamethoxazole/trimethoprim.
Hanada, K; Hirai, T; Iwamoto, T; Nakai, S; Shiraishi, C; Ushiro, M, 2022
)
0.72
"The dosage of immunosuppressant was reduced due to leucocyte dripping and fever, and antibiotic and antifungal treatment were also given."( Case report: A HIV-negative hemodialysis patient positive for pANCA with severe pneumocystis pneumonia: A case report and review of literature.
Huang, J; Li, J; Liu, D; Shen, M; Shu, Q; Xu, W; Zeng, F, 2023
)
0.91
" It is not recommended that hemodialysis patients with long-term immunosuppression should reduce or stop the dosage of immunosuppressive drugs during the treatment because it may aggravate the condition of PCP."( Case report: A HIV-negative hemodialysis patient positive for pANCA with severe pneumocystis pneumonia: A case report and review of literature.
Huang, J; Li, J; Liu, D; Shen, M; Shu, Q; Xu, W; Zeng, F, 2023
)
0.91
" The effect of prophylaxis was similar, though not always statistically significant, in sensitivity analyses that only included prophylaxis dosed more than twice-per-week (OR ."( Risk factors and prophylaxis for nocardiosis in solid organ transplant recipients: A nested case-control study.
Beam, E; Bosch, W; Challener, DW; Chesdachai, S; Duffy, D; Seville, MT; Smith, BH; Yetmar, ZA, 2023
)
0.91
" Future prospective studies are needed to improve and personalize GFR estimation and medication dosing in patients with cancer."( Medication-Related Adverse Events and Discordancies in Cystatin C-Based vs Serum Creatinine-Based Estimated Glomerular Filtration Rate in Patients With Cancer.
Gupta, S; Hanna, PE; Harden, D; Katz-Agranov, N; Leaf, DE; Moreno, D; Ouyang, T; Reynolds, KL; Seethapathy, H; Sise, ME; Strohbehn, IA; Wang, Q, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (14)

Assay IDTitleYearJournalArticle
AID162086Percent of control growth of Pneumocystis carinii trophozoites was determined2001Bioorganic & medicinal chemistry letters, Oct-22, Volume: 11, Issue:20
N,N'-bis[4-(N-alkylamidino)phenyl]homopiperazines as anti-Pneumocystis carinii agents.
AID162078Evaluated for inhibitory growth of Pneumocystis carinii cysts in lungs administered at the dose of 10 mg/kg expressed as number of lungs positive/number tested for 3 weeks; 0/52001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
FR131535, a novel water-soluble echinocandin-like lipopeptide: synthesis and biological properties.
AID151986Inhibitory concentration against Pneumocystis carinii cells in human embryonic lung fibrobalstic cell culture with MEM at 250 ug/mL1993Journal of medicinal chemistry, Oct-29, Volume: 36, Issue:22
Synthesis of 5-methyl-5-deaza nonclassical antifolates as inhibitors of dihydrofolate reductases and as potential antipneumocystis, antitoxoplasma, and antitumor agents.
AID162081Evaluated for inhibitory growth of Pneumocystis carinii cysts in lungs administered at the dose of 10 mg/kg expressed as number of lungs positive/number tested for 8 weeks; 5/52001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
FR131535, a novel water-soluble echinocandin-like lipopeptide: synthesis and biological properties.
AID162074Evaluated for inhibitory growth of Pneumocystis carinii cysts in lungs administered at the dose of 10 mg/kg expressed as number of lungs positive for lesions/number tested for 3 weeks; 0/52001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
FR131535, a novel water-soluble echinocandin-like lipopeptide: synthesis and biological properties.
AID162087Efficacy of compound was evaluated in rat infected with Pneumocystis carinii at a dose of 2 mg/Kg administered intraperitoneally2000Bioorganic & medicinal chemistry letters, Oct-02, Volume: 10, Issue:19
Enhanced pneumocystis carinii activity of new primaquine analogues.
AID162077Evaluated for inhibitory growth of Pneumocystis carinii cysts in lungs administered at the dose of 10 mg/kg expressed as number of lungs positive for trophozoites/number tested for 8 weeks; 0/52001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
FR131535, a novel water-soluble echinocandin-like lipopeptide: synthesis and biological properties.
AID162076Evaluated for inhibitory growth of Pneumocystis carinii cysts in lungs administered at the dose of 10 mg/kg expressed as number of lungs positive for trophozoites/number tested for 3 weeks; 0/52001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
FR131535, a novel water-soluble echinocandin-like lipopeptide: synthesis and biological properties.
AID162072Evaluated for inhibitory growth of Pneumocystis carinii cysts in lungs administered at the dose of 10 mg/kg expressed as number of cysts/lungs for 3 weeks2001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
FR131535, a novel water-soluble echinocandin-like lipopeptide: synthesis and biological properties.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID162075Evaluated for inhibitory growth of Pneumocystis carinii cysts in lungs administered at the dose of 10 mg/kg expressed as number of lungs positive for lesions/number tested for 8 weeks; 0/52001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
FR131535, a novel water-soluble echinocandin-like lipopeptide: synthesis and biological properties.
AID162084Anti-P. carinii activity determined as change in number of Pneumocystis carinii trophozoites from day 1 through day 7 in culture at 50/250 ug/mL2001Bioorganic & medicinal chemistry letters, Oct-22, Volume: 11, Issue:20
N,N'-bis[4-(N-alkylamidino)phenyl]homopiperazines as anti-Pneumocystis carinii agents.
AID409956Inhibition of mouse brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID162073Evaluated for inhibitory growth of Pneumocystis carinii cysts in lungs administered at the dose of 10 mg/kg expressed as number of cysts/lungs for 8 weeks2001Bioorganic & medicinal chemistry letters, Feb-12, Volume: 11, Issue:3
FR131535, a novel water-soluble echinocandin-like lipopeptide: synthesis and biological properties.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (6,890)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901247 (18.10)18.7374
1990's1650 (23.95)18.2507
2000's1566 (22.73)29.6817
2010's1813 (26.31)24.3611
2020's614 (8.91)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 25.78

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index25.78 (24.57)
Research Supply Index9.04 (2.92)
Research Growth Index4.67 (4.65)
Search Engine Demand Index36.08 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (25.78)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials875 (11.62%)5.53%
Reviews845 (11.23%)6.00%
Case Studies2,289 (30.41%)4.05%
Observational45 (0.60%)0.25%
Other3,473 (46.14%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (138)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Parallel Group, Double Blinded, 1:1, Randomized Controlled Phase III Trial of Co-trimoxazole Versus Azithromycin for the Treatment of Undifferentiated Fever In Nepal [NCT02773407]Phase 3330 participants (Actual)Interventional2016-05-23Completed
A Phase 2, Proof-of-Concept, Multicentre, Open-Label, Randomised, Active-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rezafungin Combined With 7 Days of Co-Trimoxazole Versus Co-Trimoxazole Monotherapy in HIV-Infected Adults With [NCT05835479]Phase 250 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers [NCT01137903]88 participants (Anticipated)Interventional2010-04-30Recruiting
Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics [NCT02099240]Early Phase 111 participants (Actual)Interventional2014-03-06Terminated(stopped due to Not enough patient enrollment and lack of staffing)
Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis [NCT02759120]Phase 3513 participants (Actual)Interventional2017-03-22Terminated(stopped due to Terminated for futility after review of first planned interim analysis.)
Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana [NCT01086878]Phase 4222 participants (Anticipated)Interventional2009-02-28Completed
Role of Co-trimoxazole in Severe COVID-19 Patients [NCT04470531]Phase 294 participants (Anticipated)Interventional2020-07-12Recruiting
Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital [NCT02068170]178 participants (Actual)Observational2014-02-28Completed
Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study [NCT02123628]Phase 440 participants (Actual)Interventional2007-06-30Completed
A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (T [NCT04368559]Phase 3462 participants (Anticipated)Interventional2020-05-11Recruiting
Pemberian Antibiotik Profilaksis Pada Biopsi Prostat Transperineal di RSUPN Dr. Cipto Mangunkusumo: Uji Klinis Acak Terkontrol [NCT04985110]Phase 278 participants (Anticipated)Interventional2021-07-06Recruiting
The Role of High Dose Co-trimoxazole in Severe Covid-19 Patients- A Double Blind Placebo Controlled Randomized Trial [NCT04884490]Phase 2/Phase 394 participants (Anticipated)Interventional2021-05-15Not yet recruiting
Treatment of Pneumocystis in COPD (the TOPIC Study) [NCT05418777]Phase 1/Phase 21 participants (Actual)Interventional2022-09-28Terminated(stopped due to lack of enrollment)
Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection [NCT00829686]31 participants (Actual)Interventional2008-06-30Completed
Fluoroquinolone Associated Disability [NCT03535558]239,306 participants (Actual)Observational2018-05-17Completed
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) [NCT04310930]Phase 2/Phase 3300 participants (Anticipated)Interventional2020-03-02Recruiting
Asymptomatic Bacteriuria & Risk of Urinary Tract Infection in Renal Transplants [NCT01349738]200 participants (Anticipated)Observational2011-05-31Enrolling by invitation
A Randomized Study of Cotrimoxazole Prophylaxis and Longer Breastfeeding Duration to Improve Survival Among HIV-Exposed Infants in Botswana [NCT01229761]Phase 23,724 participants (Anticipated)Interventional2011-05-31Completed
Does Post-operative Antibiotic Prophylaxis Reduce Urinary Tract Infection Rates After Holmium Laser Enucleation of Prostate? a Prospective Randomized Multi-center Study [NCT05274672]Phase 4100 participants (Anticipated)Interventional2022-03-01Not yet recruiting
Randomized Placebo-Controlled Trial of Bactrim on 7 Day Outcome in Emergency Department Patients With Uncomplicated Abscesses at Risk for Community Acquired Methicillin Resistant Staph Aureus [NCT00973765]Phase 3212 participants (Actual)Interventional2007-11-30Completed
A Randomized Controlled Trial of Monthly Dihydroartemisinin-piperaquine Versus Monthly Sulfadoxine-pyrimethamine Versus Daily Trimethoprim-sulfamethoxazole Versus No Therapy for the Prevention of Malaria [NCT00948896]Phase 3600 participants (Actual)Interventional2010-06-30Completed
Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial [NCT05977868]Phase 4135 participants (Anticipated)Interventional2023-08-04Enrolling by invitation
Effect of Antibiotics on Urinary Microbiome: Randomized Trial [NCT04230746]Early Phase 10 participants (Actual)Interventional2023-10-31Withdrawn(stopped due to funding , recruitment issues)
Randomized Clinical Trial to Assess Whether the Duration of Cotrimoxazole Preventive Therapy in HIV Patients With CD4 Counts >350 CD4 Cells/µL by Antiretroviral Treatment Influences the Rate of Carriage of Multidrug-resistant Bacteria [NCT03087890]Phase 4537 participants (Actual)Interventional2017-03-30Completed
A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy [NCT00109837]Phase 279 participants (Actual)Interventional2005-04-30Completed
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Thera [NCT01595438]Phase 3598 participants (Actual)Interventional2012-10-31Completed
Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial [NCT03042260]Phase 4310 participants (Anticipated)Interventional2017-03-01Recruiting
A Randomized Controlled Trial of Antibiotic Prophylaxis in Children With Pyelonephritis in the Abscence of Vesicoureteral Reflux [NCT00752375]Phase 30 participants (Actual)Interventional2009-02-28Withdrawn(stopped due to No participants)
A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL) [NCT00061945]Phase 1/Phase 2302 participants (Actual)Interventional2003-06-30Completed
Multi-Center, Prospective, Randomized, Double-Blinded, Controlled Clinical Trial to Evaluate the Safety and Effectiveness of an Antimicrobial Catheter Lock Solution in Maintaining Catheter Patency and Preventing Catheter Related Blood Stream Infections (C [NCT01101412]Phase 1/Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to Study was not opened.)
Clinical Efficacy of Cotrimoxazole Versus Amoxicillin in the Treatment of Community Acquired Pneumonia in Children Aged 2-59 Months Attending Mulago Hospital: A Randomized Clinical Trial. [NCT00933049]Phase 3505 participants (Actual)Interventional2007-07-31Completed
Prevention of Pregnancy-associated Malaria in HIV-infected Women : Randomised Controlled Trial Testing Cotrimoxazole Prophylaxis Versus Intermittent Preventive Treatment With Mefloquine [NCT00970879]Phase 3430 participants (Actual)Interventional2009-12-31Completed
Cotrimoxazole Prophylaxis Cessation Study Among Stabilized HIV-Infected Adult Patients on HAART in Entebbe, Uganda [NCT00674921]Phase 41,650 participants (Anticipated)Interventional2008-06-30Not yet recruiting
Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates. [NCT00822692]139 participants (Actual)Interventional2008-07-31Completed
Randomized, Double-Blind Trial of Clindamycin, Trimethoprim-Sulfamethoxazole, or Placebo for Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus [NCT00730028]Phase 21,310 participants (Actual)Interventional2009-04-30Completed
Antibiotic Comparison Exacerbation COPD [NCT00791505]Phase 3170 participants (Actual)Interventional2002-07-31Completed
Randomized Clinical Trial to Compare a Regimen of Trimethoprim-sulfamethoxazole (TMP-SMX) Plus Rifampicin With a Regimen of Linezolid in the Treatment of Infections Caused by Methicillin-resistant Staphylococcus Aureus (MRSA) [NCT00711854]Phase 4150 participants (Actual)Interventional2009-01-31Completed
The Role of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria And Its Effects in Pregnancy [NCT00711906]Phase 3352 participants (Actual)Interventional2009-02-28Terminated(stopped due to Malaria prev. fell in the study area, so we cannot evaluate the primary endpoint)
Early Oral Step-down Antibiotic Therapy Versus Continuing Intravenous Therapy for Uncomplicated Gram-negative Bacteraemia (the INVEST Trial) [NCT05199324]Phase 4720 participants (Anticipated)Interventional2022-04-01Recruiting
The PREMISE Trial: A Novel Regimen to Prevent Malaria and Sexually Transmitted Infections in Pregnant Women With HIV [NCT03431168]Phase 2308 participants (Actual)Interventional2018-03-07Completed
Randomized, Placebo Controlled Trial of Cotrimoxazole Prophylaxis Amongst HIV-uninfected Children With Severe Malnutrition [NCT00934492]Phase 31,781 participants (Actual)Interventional2009-11-30Completed
A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics [NCT00679302]Phase 4161 participants (Actual)Interventional2006-07-31Completed
A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis [NCT01420341]Phase 4667 participants (Actual)Interventional2011-08-31Completed
A Clinical Trial to Establish The Effectiveness of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria in Pregnancy [NCT01053325]Phase 3848 participants (Actual)Interventional2010-09-30Completed
A Randomized, Open-label Phase III Study of Clarithromycin, Sulfamethoxazole/Trimethoprim or Observation in Combination With Standard Therapy in Patients With Newly Diagnosed Multiple Myeloma [NCT02624440]Phase 2300 participants (Anticipated)Interventional2013-01-31Recruiting
Randomized, Double-Blinded Evaluation of Rifabutin Based Therapy for Eradication of Staphylococcus Aureus Carriage in HIV Infected Individuals With Prior Skin and Skin Structure Infections [NCT00869518]Phase 212 participants (Actual)Interventional2009-07-31Terminated(stopped due to Poor enrollment)
Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients [NCT00676130]153 participants (Actual)Interventional2007-05-31Completed
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial [NCT05696093]Phase 3628 participants (Anticipated)Interventional2023-10-19Active, not recruiting
"Strategies Using Off-Patent Antibiotics for Methicillin-Resistant Staphylococcus Aureus (STOP MRSA) - A Phase IIB, Multi-Center, Randomized, Double-Blind Clinical Trial" [NCT00729937]Phase 2/Phase 32,265 participants (Actual)Interventional2009-04-30Completed
A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Trimethoprim / Sulfamethoxazole in the Treatment of Mild-to-Moderate PCP in Patients With AIDS [NCT00000640]Phase 3290 participants InterventionalCompleted
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Pneumonia in AIDS [NCT00000715]Phase 3240 participants InterventionalCompleted
A Randomized, Comparative, Double-Blind Trial of Trimetrexate (CI-898) With Leucovorin Calcium Rescue Versus Trimethoprim / Sulfamethoxazole for Moderately Severe Pneumocystis Carinii Pneumonia in Patients With AIDS [NCT00001014]Phase 3302 participants InterventionalCompleted
Interactions Between HIV and Malaria in African Children [NCT00527800]Phase 3351 participants (Actual)Interventional2007-08-31Completed
The Use of Adjuvant Antibiotic Therapy After Incision and Drainage for Pediatric Abscess: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial [NCT00900510]0 participants (Actual)Interventional2009-05-31Withdrawn(stopped due to Recruitment of this population in the hospital setting not practical.)
Randomized Controlled Trial of Intramuscular Ceftriaxone Versus Procaine Penicillin Versus Cotrimoxazole and Gentamicin for Management of Serious Bacterial Infections in Young Infants in Community Settings [NCT00189384]Phase 3426 participants Interventional2003-11-30Active, not recruiting
A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections [NCT01049438]31 participants (Actual)Interventional2006-08-31Completed
Observational Prospective Multicenter Study to Evaluate the Infective Risk in Myelodysplastic Syndrome Patients: Antimicrobial Prophylaxis and Granulocyte Growth Factors. [NCT01951430]229 participants (Actual)Observational2014-03-31Completed
A Clinical Trial to Determine the Extent to Which Probiotic Therapy Reduces Side Effects of Antibiotic Prophylaxis in Pediatric Neurogenic Bladder Patients With a History of Recurrent Urinary Tract Infections [NCT02044965]Phase 1/Phase 236 participants (Anticipated)Interventional2015-01-31Recruiting
A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients [NCT00000748]Phase 32,500 participants InterventionalCompleted
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole and Dapsone and Their Hydroxylamine Metabolites [NCT00000826]Phase 148 participants InterventionalCompleted
Gradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis [NCT00000816]Phase 4370 participants InterventionalCompleted
Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation. [NCT00636935]Phase 40 participants (Actual)Interventional2008-02-29Withdrawn(stopped due to No patient completed protocol)
Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial [NCT02096159]93 participants (Actual)Interventional2014-03-31Active, not recruiting
A Prospective, Randomized, Blind, Multicenter Trial Comparing Orally Administered Trimethoprim-sulfamethoxazole With Intravenously Administered Cefuroxime and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery [NCT00613769]Phase 41,073 participants (Actual)Interventional2007-09-30Completed
Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy [NCT04502095]Phase 4100 participants (Anticipated)Interventional2020-09-02Recruiting
Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients Who Had CD4+ Cell Count <200 Cells/mm3 But Undetectable Plasma HIV-1 RNA [NCT01392430]74 participants (Actual)Interventional2009-06-30Completed
Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya: a Randomized Trial [NCT01425073]500 participants (Actual)Interventional2012-02-29Completed
Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection [NCT04723940]Phase 3308 participants (Anticipated)Interventional2021-01-25Enrolling by invitation
Etiology, Prevention, and Treatment of Neonatal Infections in the Community [NCT00198627]16,359 participants Interventional2003-12-31Completed
[NCT01756924]Phase 214 participants (Actual)Interventional2012-12-31Terminated(stopped due to This study has been terminated; alternative study designs are being considered. Fusidic acid remains available under an Expanded Access Protocol.)
Large Cell Lymphoma, Pilot Study III [NCT00187070]8 participants (Actual)Interventional1997-12-31Completed
Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department [NCT00867789]140 participants (Actual)Interventional2009-03-31Terminated(stopped due to Slow enrollment due to subjects not meeting inclusion/exclusion criteria)
Evaluation of the Interaction Between Low Dose Trimethoprim/Sulfamethoxazole and Zidovudine [NCT00000732]10 participants InterventionalCompleted
Use of Antibiotics to Eradicate Bacterial Pathogens Colonising the Colonic Mucosa in Ulcerative Colitis Patients [NCT00355602]40 participants (Anticipated)Interventional2006-07-31Completed
Treatment With Cotrimoxazole vs. Vancomycin for Infections Caused by Methicillin-resistant Staphylococcus Aureus: Randomized Controlled Trial [NCT00427076]Phase 3252 participants (Actual)Interventional2007-06-30Completed
Trimethoprim-Sulfamethoxazole or Levofloxacin? A Retrospective Cohort Study of Targeted Therapy for Stenotrophomonas Maltophilia Blood Stream and Lower Respiratory Tract Infections [NCT04639817]1,621 participants (Actual)Observational2020-08-14Completed
International Randomized, Controlled Phase 3 Trial of DB289 Versus Trimethoprim-sulfamethoxazole for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP) in Patients With HIV/AIDS [NCT00302341]Phase 348 participants (Actual)Interventional2006-05-31Terminated(stopped due to FDA Clinical Hold as of 12/21/07 due to safety concerns)
Long Term Study of 2 Isoniazid (INH) Prophylactic Regimens With Concomitant Cotrimoxazole (CTX) in HIV-infected Children - Impact on Morbidity, Mortality, Bacterial Resistance and Incidence of Tuberculosis [NCT00330304]Phase 3450 participants (Actual)Interventional2003-01-31Completed
Empiric Therapy With Trimethoprim-Sulfamethoxazole or Doxycycline for Outpatient Skin and Soft Tissue Infections in an Area of High MRSA Prevalence: A Prospective Randomized Trial [NCT00428818]75 participants Interventional2005-08-31Completed
Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial [NCT00126698]Phase 4100 participants Interventional2005-01-31Completed
An Evaluation of the Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on the Development of Antifolate Resistance Among Plasmodium Falciparum, Streptococcus Pneumoniae, and Escherichia Coli [NCT00137657]Phase 41,478 participants Interventional2002-02-28Completed
A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis [NCT00324922]Phase 32 participants (Actual)Interventional2006-05-01Completed
Effectiveness of 3 Day Amoxycillin Versus 5 Day co-Trimoxazole in the Treatment of Non-Severe Pneumonia in Children Aged 2- 59 Months of Age: - A Multi-Centric Open Labeled Trial [NCT00396526]Phase 32,000 participants Interventional2004-04-30Completed
A Randomized, Comparative, Double-Blind Trial of Trimetrexate (CI-898) With Leucovorin Calcium Rescue Versus Trimethoprim / Sulfamethoxazole for Moderately Severe Pneumocystis Carinii Pneumonia in Patients With AIDS [NCT00001013]Phase 3364 participants InterventionalCompleted
A Double-Blind Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine-Treated Primary Transplant Recipients [NCT00023244]Phase 2274 participants (Actual)Interventional2001-01-31Terminated(stopped due to Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder)
Calcineurin Inhibitor Sparing Protocol in Living Donor Pediatric Kidney Transplantation [NCT00023231]35 participants (Actual)Interventional2001-02-28Completed
Prophylactic Antibiotics in Measles Infection. A Community-Based Randomised Double-Blind Placebo-Controlled Trial in Guinea-Bissau [NCT00168532]Phase 3218 participants Interventional1998-01-31Completed
Single Dose Aminoglycosides for Acute Uncomplicated Cystitis in the Emergency Department Setting [NCT05702762]Phase 2160 participants (Anticipated)Interventional2022-10-01Recruiting
Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis [NCT04395365]Phase 3442 participants (Actual)Interventional2019-06-30Active, not recruiting
The Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections [NCT01507974]220 participants (Actual)Interventional2012-01-16Completed
The Effect of Probiotics on the Incidence of Spontaneous Bacterial Peritonitis in Patients With Cirrhosis and Ascites [NCT01701297]Phase 210 participants (Actual)Interventional2012-02-29Terminated(stopped due to Unable to obtain QP release certification from the manufacturer (VSL3) for shipment of IMP)
Comparative Study of Efficacy of Two Antifolates Prophylactic Strategies Against Malaria in HIV Positive Pregnant Women (MACOMBA Study) [NCT01746199]Phase 3193 participants (Actual)Interventional2013-12-31Completed
New Mexico Honey Wound Treatment Research Study [NCT01748318]Phase 260 participants (Anticipated)Interventional2013-03-31Recruiting
Prospective,Randomized,Open Label,European Multicenter Study of the Efficacy of the Linezolid-rifampin Combination Versus Standard of Care in the Treatment of Gram-positive. [NCT01757236]Phase 2100 participants (Anticipated)Interventional2012-10-31Recruiting
[NCT01768364]124 participants (Anticipated)Interventional2013-01-31Not yet recruiting
Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis [NCT01777737]Phase 33 participants (Actual)Interventional2013-11-25Terminated(stopped due to Changes in standards of care)
Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection [NCT01792804]Phase 3215 participants (Actual)Interventional2013-12-31Completed
Fosfomycin-Trometamol in Urinary Tract Infection Prophylaxis After Kidney Transplantation. Randomized Controlled Trial. [NCT01820897]Phase 4130 participants (Anticipated)Interventional2013-04-30Completed
Population Pharmacokinetic Analysis of Sulfamethoxazole and Trimethoprim in Normal Weight, Overweight, and Obese Volunteers [NCT01167452]Phase 436 participants (Actual)Interventional2010-07-31Completed
Randomized, Open-label Controlled Trial of Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on Anti-retroviral Therapy in Malawi [NCT01650558]1,499 participants (Actual)Interventional2012-11-30Completed
Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP) [NCT01659866]Phase 4563 participants (Actual)Interventional2012-08-31Completed
Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II [NCT00002571]Phase 252 participants (Actual)Interventional1994-06-30Completed
Influence of Trimethoprim-sulfamethoxazole for the Recurrence of Retinochoroiditis Toxoplasma Gondii [NCT01449877]Phase 3141 participants (Actual)Interventional2011-10-31Completed
A Randomized, Comparative Trial of Trimetrexate With Leucovorin Rescue Versus Standard Anti-Pneumocystis Therapy Versus Standard Anti-Pneumocystis Therapy With High Dose Steroids for AIDS Patients With Pneumocystis Pneumonia Who Appear to Be Refractory to [NCT00000730]Phase 3240 participants InterventionalTerminated
Pilot Study in AIDS-Related Lymphomas [NCT00002524]Phase 246 participants (Actual)Interventional1993-06-30Completed
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso [NCT03187834]Phase 4252 participants (Actual)Interventional2017-07-04Completed
A Phase I Trial of a Live, Genetically Modified Salmonella Typhimurium (VNP20009) for the Treatment of Cancer by Intratumoral Injection [NCT00004216]Phase 10 participants Interventional1999-08-31Completed
The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients [NCT00078559]Phase 1/Phase 210 participants (Actual)Interventional2003-11-30Completed
A Randomised Controlled Trial of Continuing Immunoglobulin Therapy, or Stopping With or Without Prophylactic Antibiotics, on Infection Rate in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies. [NCT05678621]Phase 2/Phase 3300 participants (Anticipated)Interventional2023-01-31Not yet recruiting
Efficacy of Combination Therapy With Minocycline for Treatment of Stenotrophomonas Maltophilia Infections [NCT05575427]Phase 4112 participants (Anticipated)Interventional2022-11-24Recruiting
Pharmacokinetic Parameters of 960 mg Co-trimoxazole Once Daily in Patients With Tuberculosis [NCT01832987]Phase 212 participants (Actual)Interventional2013-10-31Completed
Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis [NCT03919435]Phase 1/Phase 28 participants (Actual)Interventional2019-03-27Active, not recruiting
Evaluation of the Interaction Between High Dose Trimethoprim/Sulfamethoxazole and Zidovudine [NCT00000734]10 participants InterventionalCompleted
A Randomized, Phase II/III, Double-Blind, Two-Armed Study of Micronized Atovaquone and Azithromycin (AT/AZ) as Compared to Trimethoprim-Sulfamethoxazole (TMP/SMX) in the Prevention of Serious Bacterial Infections When Used in Children Aged 3 Months to 19 [NCT00000811]Phase 2690 participants InterventionalCompleted
A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients [NCT00000655]Phase 2300 participants InterventionalCompleted
A Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection [NCT00000991]Phase 3600 participants InterventionalCompleted
A Controlled Comparative Trial of Trimethoprim - Sulfamethoxazole Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) [NCT00000727]Phase 3322 participants InterventionalCompleted
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Thera [NCT01599806]Phase 3641 participants (Actual)Interventional2012-10-31Completed
Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux. [NCT00382343]Phase 496 participants (Actual)Interventional1999-11-30Completed
Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary? [NCT02593903]67 participants (Actual)Interventional2014-03-04Completed
Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial. [NCT00367081]Phase 430 participants Interventional2003-05-31Completed
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia [NCT04851015]Phase 3300 participants (Anticipated)Interventional2022-06-30Not yet recruiting
STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) [NCT03489629]Phase 242 participants (Anticipated)Interventional2018-04-03Recruiting
Antibiotic Profile of Pathogenic Bacteria Isolated From Postsurgical Site Infections in Public Hospitals in Northern Jordan [NCT05106803]24 participants (Actual)Observational2019-08-01Completed
Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media [NCT00189098]101 participants (Actual)Interventional2003-02-28Completed
Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial [NCT01108757]52 participants (Actual)Interventional2010-04-30Terminated(stopped due to Unfeasible because of low accrual)
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) [NCT00405704]Phase 3607 participants (Actual)Interventional2007-05-31Completed
Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage [NCT02024867]249 participants (Actual)Interventional2010-02-28Completed
Pharmacokinetics of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children Using PBPK [NCT02475876]Phase 151 participants (Actual)Interventional2015-11-30Completed
Long-term StaphyloCoccus Aureus decolonizAtion in Patients on Home parenteRal nutRition: a randomIzed multicEnter tRial. [NCT03173053]63 participants (Actual)Interventional2018-02-08Terminated(stopped due to Results interim-analysis)
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis [NCT05398679]Phase 4360 participants (Anticipated)Interventional2022-06-01Not yet recruiting
A Prospective Randomized Trial of 2 Weeks vs 3 Months of Antibiotics Post Percutaneous Nephrolithotomy for the Prevention of Infection-Related Kidney Stones [NCT02375295]Phase 428 participants (Anticipated)Interventional2015-03-31Recruiting
Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections [NCT03378427]35 participants (Actual)Interventional2018-08-28Completed
Collaborative Urological Prosthetics Investigation Directive Research Group [NCT05100654]800 participants (Anticipated)Interventional2022-04-22Recruiting
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study [NCT05302531]Phase 110 participants (Anticipated)Interventional2022-12-09Recruiting
A Randomised Trial of Monitoring Practice and Induction Maintenance Drug Regimens in the Management of Antiretroviral Therapy in Children With HIV Infection in Africa [NCT02028676]Phase 41,206 participants (Actual)Interventional2007-03-31Completed
The Effect of Rectal Swab Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy on Infectious Complications and Cost of Care: A Randomized Controlled Trial in the Netherlands. [NCT03228108]Phase 41,538 participants (Actual)Interventional2018-04-03Completed
Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for the Treatment of Diabetic Foot Osteomyelitis (CRO-OSTEOMYELITIS) [NCT02168816]Phase 230 participants (Actual)Interventional2014-03-19Terminated(stopped due to The study was stopped for feasibility (i.e., low recruitment))
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00061945 (6) [back to overview]Number of Participants Achieving Complete Remission
NCT00061945 (6) [back to overview]Overall Survival
NCT00061945 (6) [back to overview]Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)
NCT00061945 (6) [back to overview]Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)
NCT00061945 (6) [back to overview]Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II)
NCT00061945 (6) [back to overview]Disease-free Survival, for Only Complete Response Patients
NCT00078559 (14) [back to overview]Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Deaths Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status
NCT00078559 (14) [back to overview]Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period
NCT00078559 (14) [back to overview]Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated
NCT00078559 (14) [back to overview]Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal
NCT00078559 (14) [back to overview]Number of Acute Rejections in All Enrolled Participants
NCT00078559 (14) [back to overview]Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study
NCT00078559 (14) [back to overview]Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status
NCT00109837 (2) [back to overview]Toxicity
NCT00109837 (2) [back to overview]Continuous Complete Remission at 1 Year
NCT00189098 (6) [back to overview]Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear
NCT00189098 (6) [back to overview]Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.
NCT00189098 (6) [back to overview]Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.
NCT00189098 (6) [back to overview]Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up
NCT00189098 (6) [back to overview]Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up
NCT00189098 (6) [back to overview]Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.
NCT00405704 (8) [back to overview]Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)
NCT00405704 (8) [back to overview]Outcome Renal Scarring
NCT00405704 (8) [back to overview]New Renal Scarring on Outcome Scan
NCT00405704 (8) [back to overview]Recurrent Febrile or Symptomatic UTI With Resistant E. Coli
NCT00405704 (8) [back to overview]Severe Renal Scarring on Outcome Scan
NCT00405704 (8) [back to overview]Treatment Failure Composite
NCT00405704 (8) [back to overview]Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up
NCT00405704 (8) [back to overview]Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen
NCT00676130 (2) [back to overview]Relative Efficacy
NCT00676130 (2) [back to overview]Progression to Abscess
NCT00679302 (2) [back to overview]Skin Abscess Resolution
NCT00679302 (2) [back to overview]New Lesion Development and Spread of Skin Abscesses (on Subject)
NCT00729937 (31) [back to overview]Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
NCT00729937 (31) [back to overview]Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
NCT00729937 (31) [back to overview]Mean Days Missed From Normal Activities in the Per Protocol Population
NCT00729937 (31) [back to overview]Mean Days Missed From Normal Activities in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population
NCT00729937 (31) [back to overview]Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population
NCT00729937 (31) [back to overview]Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population
NCT00730028 (8) [back to overview]Number of Participants Reporting Adverse Events That Are Treatment Limiting.
NCT00730028 (8) [back to overview]Number of Participants Reporting Adverse Events.
NCT00730028 (8) [back to overview]Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.
NCT00730028 (8) [back to overview]Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.
NCT00730028 (8) [back to overview]Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.
NCT00730028 (8) [back to overview]Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.
NCT00730028 (8) [back to overview]Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.
NCT00730028 (8) [back to overview]Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.
NCT00822692 (1) [back to overview]Recurrence Rates of Abscesses
NCT00829686 (2) [back to overview]Clinical Improvement at 7 Days After Incision and Drainage
NCT00829686 (2) [back to overview]Recurrence Rates
NCT00867789 (1) [back to overview]Health Outcomes After Use With Trimethoprim-sulfamethaxazole
NCT00869518 (3) [back to overview]Eradication of S. Aureus Colonization
NCT00869518 (3) [back to overview]Eradication of S. Aureus Colonization
NCT00869518 (3) [back to overview]Recurrent Skin and Skin Structure Infections (SSTI)
NCT00948896 (4) [back to overview]Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
NCT00948896 (4) [back to overview]Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants
NCT00948896 (4) [back to overview]Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants
NCT00948896 (4) [back to overview]Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk
NCT00973765 (1) [back to overview]Treatment Failures at 7 Days
NCT01108757 (1) [back to overview]Number of Participants With Urinary Tract Infection
NCT01167452 (1) [back to overview]Elimination Rate Constants for Sulfamethoxazole and Trimethoprim
NCT01595438 (63) [back to overview]Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
NCT01595438 (63) [back to overview]Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
NCT01595438 (63) [back to overview]Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
NCT01595438 (63) [back to overview]Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
NCT01595438 (63) [back to overview]Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at LFU (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
NCT01595438 (63) [back to overview]Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at LFU (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
NCT01599806 (63) [back to overview]Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
NCT01599806 (63) [back to overview]Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
NCT01599806 (63) [back to overview]Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
NCT01599806 (63) [back to overview]Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
NCT01599806 (63) [back to overview]Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
NCT01599806 (63) [back to overview]Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
NCT01599806 (63) [back to overview]Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
NCT01599806 (63) [back to overview]Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
NCT01599806 (63) [back to overview]Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
NCT01650558 (6) [back to overview]CD4 Cell Count
NCT01650558 (6) [back to overview]Severe Events
NCT01650558 (6) [back to overview]Number of Participants With at Least One Detectable HIV Viral Load
NCT01650558 (6) [back to overview]Bacterial Infections and Malaria
NCT01650558 (6) [back to overview]Adverse Events Greater Than or Equal to Grade 3 That Are Related to the Study Product
NCT01650558 (6) [back to overview]WHO HIV Stage 2, 3, 4 Illness
NCT01659866 (1) [back to overview]Number of Participants With Post-biopsy Infection.
NCT02024867 (6) [back to overview]Recurrent Skin Infections
NCT02024867 (6) [back to overview]Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
NCT02024867 (6) [back to overview]Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
NCT02024867 (6) [back to overview]Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
NCT02024867 (6) [back to overview]Treatment Failures
NCT02024867 (6) [back to overview]Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
NCT02028676 (58) [back to overview]Cotrimoxazole: New Clinical and Diagnostic Positive Malaria
NCT02028676 (58) [back to overview]Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]Cotrimoxazole: New Severe Pneumonia
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]Cotrimoxazole: Weight-for-age Z-score
NCT02028676 (58) [back to overview]Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation
NCT02028676 (58) [back to overview]Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation
NCT02028676 (58) [back to overview]Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Induction ART: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: All-cause Mortality
NCT02028676 (58) [back to overview]Cotrimoxazole: New Hospitalisation or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Height-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New ART-modifying Adverse Event
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Weight-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM: Change From Baseline in CD4% to Week 144
NCT02028676 (58) [back to overview]LCM vs CDM: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline
NCT02028676 (58) [back to overview]CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline
NCT02028676 (58) [back to overview]Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]Cotrimoxazole: All-cause Mortality
NCT02028676 (58) [back to overview]Cotrimoxazole: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72
NCT02028676 (58) [back to overview]Cotrimoxazole: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]Cotrimoxazole: Height-for-age Z-score
NCT02759120 (17) [back to overview]Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score
NCT02759120 (17) [back to overview]Change in Leicester Cough Questionnaire Score
NCT02759120 (17) [back to overview]Change in SF-12 Health Survey (SF-12) Mental Score
NCT02759120 (17) [back to overview]Change in Short Form-12 Health Survey (SF-12) 6D Score
NCT02759120 (17) [back to overview]Change in Short Form-12 Health Survey (SF-12) Physical Score
NCT02759120 (17) [back to overview]Change in UCSD-Shortness of Breath Questionnaire
NCT02759120 (17) [back to overview]Number of Participants With Death From Any Cause
NCT02759120 (17) [back to overview]Number of Participants With First Non-elective, All-cause Hospitalization
NCT02759120 (17) [back to overview]Number of Participants With First Non-elective, Respiratory Hospitalization
NCT02759120 (17) [back to overview]Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality
NCT02759120 (17) [back to overview]Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)
NCT02759120 (17) [back to overview]Percent Change in Forced Vital Capacity (FVC)
NCT02759120 (17) [back to overview]Total Number of Non-elective All-cause Hospitalizations
NCT02759120 (17) [back to overview]Total Number of Non-elective Respiratory Hospitalizations
NCT02759120 (17) [back to overview]Total Number of Respiratory Infections
NCT02759120 (17) [back to overview]Change in EuroQol Index (EQ-5D) Score
NCT02759120 (17) [back to overview]Change in Fatigue Severity Scale Score
NCT03187834 (13) [back to overview]Height-for-age Z-score
NCT03187834 (13) [back to overview]Height-for-age Z-score
NCT03187834 (13) [back to overview]L1-norm Distance on Bacterial Reads (Intestinal)
NCT03187834 (13) [back to overview]L2-norm Distance on Bacterial Reads (Intestinal)
NCT03187834 (13) [back to overview]Mid-upper Arm Circumference
NCT03187834 (13) [back to overview]Mid-upper Arm Circumference
NCT03187834 (13) [back to overview]Shannon's Index of Diversity (Alpha Diversity) in Intestinal Microbiome
NCT03187834 (13) [back to overview]Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome
NCT03187834 (13) [back to overview]Weight-for-age Z-score
NCT03187834 (13) [back to overview]Weight-for-age Z-score
NCT03187834 (13) [back to overview]Weight-for-height Z-score
NCT03187834 (13) [back to overview]Weight-for-height Z-score
NCT03187834 (13) [back to overview]Number of Participants With Macrolide Resistance Genes
NCT03431168 (10) [back to overview]Proportion With Adverse Birth Outcomes
NCT03431168 (10) [back to overview]Proportion of Participants With Symptomatic Malaria
NCT03431168 (10) [back to overview]Plasmodium Falciparum Peripheral Parasitemia
NCT03431168 (10) [back to overview]Maternal Adherence to the Prophylactic Regimen
NCT03431168 (10) [back to overview]Low Birthweight (<2500 Grams)
NCT03431168 (10) [back to overview]GBS Colonization
NCT03431168 (10) [back to overview]Composite STI Measure (Including All STI Tests)
NCT03431168 (10) [back to overview]Proportion With Placental Malaria
NCT03431168 (10) [back to overview]Proportion With Maternal Anemia and Severe Maternal Anemia
NCT03431168 (10) [back to overview]Proportion With Composite STI Outcome
NCT05418777 (14) [back to overview]Time to Return to Baseline Oxygen for the Current AECOPD
NCT05418777 (14) [back to overview]Number of Urgent Care Visits (Total)
NCT05418777 (14) [back to overview]Number of Urgent Care Visits (Related to COPD)
NCT05418777 (14) [back to overview]Number of Hospital Admissions (Total)
NCT05418777 (14) [back to overview]Number of Hospital Admissions (Related to COPD)
NCT05418777 (14) [back to overview]Need for Medications to Treat COPD
NCT05418777 (14) [back to overview]Need for Mechanical Ventilation
NCT05418777 (14) [back to overview]Mortality
NCT05418777 (14) [back to overview]Interval Between Exacerbations of COPD
NCT05418777 (14) [back to overview]Interval Between Hospital Admissions
NCT05418777 (14) [back to overview]Change in the COPD Assessment Test
NCT05418777 (14) [back to overview]Length of Stay for Current AECOPD
NCT05418777 (14) [back to overview]Clearance of PJ From Treated Patients
NCT05418777 (14) [back to overview]Durability of Clearance of PJ From Treated Patients

Number of Participants Achieving Complete Remission

A complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) > 1500/μl, no circulating blasts, platelets > 100,000/μl; bone marrow cellularity > 20% with trilineage hematopoiesis, and < 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement). (NCT00061945)
Timeframe: 9 years

Interventionparticipants (Number)
Phase I - Alemtuzumab and Combination Chemotherapy92
Phase II - Alemtuzumab and Combination Chemotherapy145

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Overall Survival

Overall Survival is defines as the time from registration to death due to any cause. It is estimated using the Kaplan-Meier method with confidence intervals presented. (NCT00061945)
Timeframe: 9 years 4 months

Interventionmonths (Median)
Phase I - Alemtuzumab and Combination Chemotherapy33.6
Phase II - Alemtuzumab and Combination Chemotherapy23.1

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Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)

The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV. (NCT00061945)
Timeframe: 8 months

Interventionparticipants (Number)
Phase II - Alemtuzumab and Combination Chemotherapy30

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Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)

The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data. (NCT00061945)
Timeframe: 6 weeks

Interventionmg (Number)
Phase I - Alemtuzumab and Combination Chemotherapy30

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Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II)

Minimal Residual Disease measures the presence of of circulating leukemia cells in the body. Patients that report a Complete Response (CR) during treatment are further tested to determine the presence of small amounts of circulating leukemia cells. Here we report the number of patients who were MRD negative. (NCT00061945)
Timeframe: 9 years 4 months

InterventionParticipants (Count of Participants)
Phase II - Alemtuzumab and Combination Chemotherapy16

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Disease-free Survival, for Only Complete Response Patients

Disease Free Survival (DFS) is defined as the time from a Complete Response (CR) until death or relapse. The date of last clinical assesment will be used as the censor date for patients with no death or relapse. The DFS will be estimated using the Kaplan-Meier method with confidence intervals presented. (NCT00061945)
Timeframe: 9 years 4 months

Interventionmonths (Median)
Phase I - Alemtuzumab and Combination Chemotherapy58.6
Phase II - Alemtuzumab and Combination Chemotherapy19.8

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Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)8

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Number of Deaths Stratified by Sirolimus Withdrawal Status

Participants who died during the study, all cause(s) (NCT00078559)
Timeframe: Transplantation to Death (up to four years post-transplant)

Interventiondeaths (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status

"Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy~1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to four years post-transplantation)

Interventionparticipants (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status

"Participants who experienced graft loss[1] during study~[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation" (NCT00078559)
Timeframe: Transplantation to Graft Loss (up to four years post-transplantation)

Interventionparticipants (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status

"Participants who experienced severe acute rejections[1] during study~Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to severe acute rejection (up to four years post-transplantation)

InterventionRejection Events (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status

Side effects of conventional immunosuppression include increased body weight and hypertension (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionside effects (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)6

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Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)7

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Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)2

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Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period

"Time (days) to acute rejection[1] for participants occurring during the year following transplantation~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to one year post-transplant)

InterventionDays (Number)
Alemtuzumab274

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Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated

"Time (days) to acute rejection[1] for participants where sirolimus was not initiated~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to four years post-transplantation)

InterventionDays (Number)
Alemtuzumab274

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Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal

"Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

InterventionRejection Events (Number)
Alemtuzumab0

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Number of Acute Rejections in All Enrolled Participants

"Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)~Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Four years post-transplant

InterventionRejection Events (Number)
Alemtuzumab1

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Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study

"Acute rejections[1] between initiation of sirolimus withdrawal and end of study~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Initiation of sirolimus to end of study (up to four years post-transplant)

InterventionRejection Events (Number)
Alemtuzumab0

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Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status

Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 - 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionmg/dL (Mean)
Alemtuzumab (Withdrawn From Sirolimus)-4.2
Alemtuzumab (Not Withdrawn From Sirolimus)-5.4

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Toxicity

Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event (NCT00109837)
Timeframe: Patients were assessed for adverse events after the induction cycle

InterventionParticipants with a given type of AE (Number)
ALT, SGPT (serum glutamic pyruvic transaminase)AST, SGOT (serum glut oxaloacetic transaminase)Albumin, serum-low (hypoalbuminemia)Alkaline phosphataseAnorexiaAscites (non-malignant)Bilirubin (hyperbilirubinemia)Calcium, serum-low (hypocalcemia)CholecystitisCholesterol, serum-high (hypercholesterolemia)Coagulation-Other (Specify)Colitis, infectious (e.g., Clostridium difficile)ConstipationDIC (disseminated intravascular coagulation)Death not assoc with CTCAE term-Multi-organ failEdema: limbFatigue (asthenia, lethargy, malaise)Febrile neutropeniaFever (in the abs of neutropenia)FibrinogenGlucose, serum-high (hyperglycemia)Glucose, serum-low (hypoglycemia)HemoglobinHypertensionHypotensionHypoxiaIleus, GI (functional obstruction of bowel)Infec(doc clin or mibio) w/ Gr 3/4 neut-AnalInfec(doc clin or mibio) w/ Gr 3/4 neut-BladderInfec(doc clin or mibio) w/ Gr 3/4 neut-BloodInfec(doc clin or mibio) w/ Gr 3/4 neut-BronchusIInfec(doc clin or mibio) w/ Gr 3/4 neut-CatheterInfec(doc clin or mibio) w/ Gr 3/4 neut-Eye NOSInfec(doc clin or mibio) w/ Gr 3/4 neut-LungInfec(doc clin or mibio) w/ Gr 3/4 neut-NoseInfec(doc clin or mibio) w/ Gr 3/4 neut-PharynxInfec(doc clin or mibio) w/ Gr 3/4 neut-Ur tractInfec with nor ANC or Gr 1/2 neut-Lung (pneumonia)Infection-Other (Specify)Leukocytes (total WBC)LipaseLiver dysfunction/failure (clinical)LymphopeniaMagnesium, serum-high (hypermagnesemia)Mucositis/stomatitis (clinical exam) - Oral cavityMucositis/stomatitis (funct/symp) - Oral cavityMucositis/stomatitis (func/symp) - PharynxMuscle weak,gen spec area-Whole bodyNauseaNeuropathy: motorNeutrophils/granulocytes (ANC/AGC)Pain - Abdomen NOSPain - BonePain - NeckPancreatic endocrine: glucose intolerancePancreatitisPhosphate, serum-low (hypophosphatemia)PlateletsPotassium, serum-high (hyperkalemia)Potassium, serum-low (hypokalemia)Rash/desquamationRenal failureSodium, serum-low (hyponatremia)Thrombosis/thrombus/embolismThrombotic microangiopathyTriglyceride, serum-high (hypertriglyceridemia)Tumor lysis syndromeTyphlitis (cecal inflammation)Uric acid, serum-high (hyperuricemia)Vomiting
Induction171332216712111211318111161332321111111111122143121912112314711111144171261215111

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Continuous Complete Remission at 1 Year

A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study. (NCT00109837)
Timeframe: After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year

Interventionparticipants (Number)
Treatment21

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Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear

The primary endpoint was otomicroscopic signs of otorrhea in either ear in the presence of a tympanostomy tube or tympanic membrane perforation at 6 and 12 weeks and 1 year follow-up. At these follow-up moments the participants were checked for the presence of otorrhea using an otomicroscope. (NCT00189098)
Timeframe: 6, 12 weeks and 1 year follow-up.

,
Interventionparticipants (Number)
At 6 weeksAt 12 weeksAt 12 months
Placebo27239
Sulfamethoxazole-trimethoprim131511

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Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.

Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. (NCT00189098)
Timeframe: between 6 and 12 weeks follow-up

Interventionparticipants (Number)
Sulfamethoxazole-trimethoprim4
Placebo7

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Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.

Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. (NCT00189098)
Timeframe: between 12 weeks and 1 year follow-up

Interventionparticipants (Number)
Sulfamethoxazole-trimethoprim23
Placebo18

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Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up

Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits. (NCT00189098)
Timeframe: Between 6 to12 week follow up

Interventionparticipants (Number)
Sulfamethoxazole-trimethoprim21
Placebo26

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Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up

Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits. (NCT00189098)
Timeframe: between 12 weeks to 1 year follow-up

Interventionparticipants (Number)
Sulfamethoxazole-trimethoprim29
Placebo31

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Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.

After 12 weeks follow-up irrespective of the presence or absence of otorrhea the study medication was discontinued. After the first 12 weeks local otorhinolaryngologists and paediatricians were free to manage symptoms of otorrhea according to their regular practice. Parents kept a diary between 12 weeks and 1 year follow-up where Ear Nose and Throat Surgery was noted. This outcome describes the number of patients who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up. (NCT00189098)
Timeframe: between 12 weeks and 1 year follow-up

Interventionparticipants (Number)
Sulfamethoxazole-trimethoprim13
Placebo11

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Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)

(NCT00405704)
Timeframe: 2 years

Interventionparticipants (Number)
Trimethoprim-Sulfamethoxazole56
Placebo41

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Outcome Renal Scarring

Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria. (NCT00405704)
Timeframe: 2 years

Interventionparticipants (Number)
Trimethoprim-Sulfamethoxazole27
Placebo24

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New Renal Scarring on Outcome Scan

New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria. (NCT00405704)
Timeframe: 2 years

Interventionparticipants (Number)
Trimethoprim-Sulfamethoxazole18
Placebo19

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Recurrent Febrile or Symptomatic UTI With Resistant E. Coli

(NCT00405704)
Timeframe: 2 years

Interventionparticipants (Number)
Trimethoprim-Sulfamethoxazole19
Placebo11

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Severe Renal Scarring on Outcome Scan

Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria. (NCT00405704)
Timeframe: 2 years

Interventionparticipants (Number)
Trimethoprim-Sulfamethoxazole9
Placebo6

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Treatment Failure Composite

Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria. (NCT00405704)
Timeframe: 2 years

Interventionparticipants (Number)
Trimethoprim-Sulfamethoxazole14
Placebo27

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Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up

(NCT00405704)
Timeframe: 2 years

Interventionparticipants (Number)
Trimethoprim-Sulfamethoxazole39
Placebo72

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Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen

(NCT00405704)
Timeframe: 2 years

Interventionparticipants (Number)
Trimethoprim-Sulfamethoxazole26
Placebo17

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Relative Efficacy

"Proportion of subjects in each arm with successful treatment.~Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days." (NCT00676130)
Timeframe: 12 +/- 2 days; 30 +/- 2 days

Interventionparticipants (Number)
Trimethoprim-sulfamethoxazole62
Placebo60

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Progression to Abscess

Proportion of subjects in each arm with progression from cellulitis to abscess. (NCT00676130)
Timeframe: 12 +/- 2 days, 30 days +/- 2 days

Interventionparticipants (Number)
Trimethoprim-sulfamethoxazole5
Placebo5

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Skin Abscess Resolution

(NCT00679302)
Timeframe: 10-14 days

Interventionparticipants (Number)
Placebo Group4
Antibiotic Group3

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New Lesion Development and Spread of Skin Abscesses (on Subject)

The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up. (NCT00679302)
Timeframe: 10-14 days and 3 month

Interventionparticipants (Number)
Placebo Group15
Antibiotic Group13

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Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class

All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class. (NCT00729937)
Timeframe: Day 1 through Day 49-63

,,,,,
Interventionparticipants (Number)
Cardiac disordersEye disordersGastrointestinal disordersGeneral disorders and administration site conditioInfections and infestationsInjury, poisoning and procedural complicationsInvestigationsMetabolism and nutrition disordersMusculoskeletal and connective tissue disordersNervous system disordersPsychiatric disordersRenal and urinary disordersReproductive system and breast disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersVascular disorders
Abscess, Placebo03164651173380213102
Abscess, TMP/SMX0119811400113441000140
Cellulitis, Cephalexin007321000020000070
Cellulitis, Cephalexin and TMP/SMX0087210030160110150
Infected Wound, Clindamycin109311004015001060
Infected Wound, TMP/SMX008231012016010050

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Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population

Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. (NCT00729937)
Timeframe: Days 14-21

,,,,,
Interventionparticipants (Number)
Clinical CureClinical Failure
Abscess, Placebo45776
Abscess, TMP/SMX48737
Cellulitis, Cephalexin16528
Cellulitis, Cephalexin and TMP/SMX18236
Infected Wound, Clindamycin18716
Infected Wound, TMP/SMX18216

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Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population

Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. (NCT00729937)
Timeframe: Days 14-21

,,,,,
Interventionparticipants (Number)
Clinical CureClinical Failure
Abscess, Placebo454163
Abscess, TMP/SMX507123
Cellulitis, Cephalexin17177
Cellulitis, Cephalexin and TMP/SMX18959
Infected Wound, Clindamycin19851
Infected Wound, TMP/SMX19753

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Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population

Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria. (NCT00729937)
Timeframe: Day 14-21

,,,,,
Interventionparticipants (Number)
Presumed eradicationPersistenceNew infectionSuper-infectionUnclassifiedIndeterminate
Abscess, Placebo4573918280
Abscess, TMP/SMX4871504180
Cellulitis, Cephalexin1650001117
Cellulitis, Cephalexin and TMP/SMX1820001323
Infected Wound, Clindamycin18761090
Infected Wound, TMP/SMX18252090

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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population

The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 8-10

,,,,,
Interventionparticipants (Number)
No reduction>0%-5% reduction>5%-10% reduction>10%-15% reduction>15%-20% reduction>20%-25% reduction>25%-30% reduction>30%-35% reduction>35%-40% reduction>40%-45% reduction>45%-50% reduction>50%-55% reduction>55%-60% reduction>60%-65% reduction>65%-70% reduction>70%-75% reduction>75%-80% reduction>80%-85% reduction>85%-90% reduction>90%-95% reduction>95%-100% reduction
Abscess, Placebo50100020202402436479531
Abscess, TMP/SMX30010011130150322597532
Cellulitis, Cephalexin50010011010222322267188
Cellulitis, Cephalexin and TMP/SMX50100101100015253042198
Infected Wound, Clindamycin30010000001112121442208
Infected Wound, TMP/SMX30010110031213232125197

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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population

The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 8-10

,,,,,
Interventionparticipants (Number)
No reduction>0%-5% reduction>5%-10% reduction>10%-15% reduction>15%-20% reduction>20%-25% reduction>25%-30% reduction>30%-35% reduction>35%-40% reduction>40%-45% reduction>45%-50% reduction>50%-55% reduction>55%-60% reduction>60%-65% reduction>65%-70% reduction>70%-75% reduction>75%-80% reduction>80%-85% reduction>85%-90% reduction>90%-95% reduction>95%-100% reduction
Abscess, Placebo40100020202401436479478
Abscess, TMP/SMX30010011130150322577478
Cellulitis, Cephalexin50000011010221222144162
Cellulitis, Cephalexin and TMP/SMX50100101100015252041183
Infected Wound, Clindamycin30000000001112101341182
Infected Wound, TMP/SMX30010010021213232113167

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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population

The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 3-4

,,,,,
Interventionparticipants (Number)
No reduction>0%-5% reduction>5%-10% reduction>10%-15% reduction>15%-20% reduction>20%-25% reduction>25%-30% reduction>30%-35% reduction>35%-40% reduction>40%-45% reduction>45%-50% reduction>50%-55% reduction>55%-60% reduction>60%-65% reduction>65%-70% reduction>70%-75% reduction>75%-80% reduction>80%-85% reduction>85%-90% reduction>90%-95% reduction>95%-100% reduction
Abscess, Placebo67323271213122013141215211817202015298
Abscess, TMP/SMX43243756815171571124102022201616328
Cellulitis, Cephalexin412102537661098496869880
Cellulitis, Cephalexin and TMP/SMX34165545469549167119116674
Infected Wound, Clindamycin181145346476827691731111108
Infected Wound, TMP/SMX121314655386741271011957111

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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population

The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 3-4

,,,,,
Interventionparticipants (Number)
No reduction>0%-5% reduction>5%-10% reduction>10%-15% reduction>15%-20% reduction>20%-25% reduction>25%-30% reduction>30%-35% reduction>35%-40% reduction>40%-45% reduction>45%-50% reduction>50%-55% reduction>55%-60% reduction>60%-65% reduction>65%-70% reduction>70%-75% reduction>75%-80% reduction>80%-85% reduction>85%-90% reduction>90%-95% reduction>95%-100% reduction
Abscess, Placebo59313261113121612131014191413191813262
Abscess, TMP/SMX3724363671315126102191721181316284
Cellulitis, Cephalexin33210243726968375768667
Cellulitis, Cephalexin and TMP/SMX3015534526854915798105571
Infected Wound, Clindamycin1710352353666265716381089
Infected Wound, TMP/SMX111314554375641268684587

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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population

The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 14-21

,,,,,
Interventionparticipants (Number)
No reduction>0%-5% reduction>5%-10% reduction>10%-15% reduction>15%-20% reduction>20%-25% reduction>25%-30% reduction>30%-35% reduction>35%-40% reduction>40%-45% reduction>45%-50% reduction>50%-55% reduction>55%-60% reduction>60%-65% reduction>65%-70% reduction>70%-75% reduction>75%-80% reduction>80%-85% reduction>85%-90% reduction>90%-95% reduction>95%-100% reduction
Abscess, Placebo20000000000000002044561
Abscess, TMP/SMX00000100000000001211559
Cellulitis, Cephalexin00100000100000011000217
Cellulitis, Cephalexin and TMP/SMX20000000010000121100220
Infected Wound, Clindamycin10000010000000100001219
Infected Wound, TMP/SMX10010010000100110001216

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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population

The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 14-21

,,,,,
Interventionparticipants (Number)
No reduction>0%-5% reduction>5%-10% reduction>10%-15% reduction>15%-20% reduction>20%-25% reduction>25%-30% reduction>30%-35% reduction>35%-40% reduction>40%-45% reduction>45%-50% reduction>50%-55% reduction>55%-60% reduction>60%-65% reduction>65%-70% reduction>70%-75% reduction>75%-80% reduction>80%-85% reduction>85%-90% reduction>90%-95% reduction>95%-100% reduction
Abscess, Placebo20000000000000002044520
Abscess, TMP/SMX00000100000000000211516
Cellulitis, Cephalexin00100000000000011000189
Cellulitis, Cephalexin and TMP/SMX20000000010000121100207
Infected Wound, Clindamycin10000000000000000001199
Infected Wound, TMP/SMX10010010000100110000191

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Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population

Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. (NCT00729937)
Timeframe: Day 1 through Day 14-21

Interventionparticipants (Number)
Abscess, Placebo0
Abscess, TMP/SMX1
Infected Wound, TMP/SMX0
Infected Wound, Clindamycin0
Cellulitis, Cephalexin and TMP/SMX0
Cellulitis, Cephalexin0

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Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population

At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63

Interventionparticipants (Number)
Abscess, Placebo35
Abscess, TMP/SMX25
Infected Wound, TMP/SMX6
Infected Wound, Clindamycin11
Cellulitis, Cephalexin and TMP/SMX11
Cellulitis, Cephalexin5

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Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population

At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63

Interventionparticipants (Number)
Abscess, Placebo33
Abscess, TMP/SMX20
Infected Wound, TMP/SMX6
Infected Wound, Clindamycin9
Cellulitis, Cephalexin and TMP/SMX10
Cellulitis, Cephalexin5

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Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population

At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21

Interventionparticipants (Number)
Abscess, Placebo22
Abscess, TMP/SMX12
Infected Wound, TMP/SMX1
Infected Wound, Clindamycin6
Cellulitis, Cephalexin and TMP/SMX7
Cellulitis, Cephalexin4

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Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population

At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21

Interventionparticipants (Number)
Abscess, Placebo22
Abscess, TMP/SMX9
Infected Wound, TMP/SMX1
Infected Wound, Clindamycin5
Cellulitis, Cephalexin and TMP/SMX6
Cellulitis, Cephalexin4

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Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population

Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary. (NCT00729937)
Timeframe: Day 14-21

,,,,,
Interventionparticipants (Number)
Composite Clinical CureComposite Clinical Failure
Abscess, Placebo396137
Abscess, TMP/SMX45371
Cellulitis, Cephalexin14944
Cellulitis, Cephalexin and TMP/SMX16058
Infected Wound, Clindamycin11489
Infected Wound, TMP/SMX11385

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Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population

As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. (NCT00729937)
Timeframe: Day 1 through 14

,,,,,
Interventionparticipants (Number)
Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13Day 14
Abscess, Placebo58384547273427342414191915146
Abscess, TMP/SMX8134643442293240261510145127
Cellulitis, Cephalexin2861013422866426345
Cellulitis, Cephalexin and TMP/SMX187151610109109531251
Infected Wound, Clindamycin3710241091312119443750
Infected Wound, TMP/SMX321518169131384624259

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Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population

As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. (NCT00729937)
Timeframe: Day 1 through 14

,,,,,
Interventionparticipants (Number)
Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13Day 14
Abscess, Placebo44374139242924312212161812130
Abscess, TMP/SMX5632493240272735211310123107
Cellulitis, Cephalexin17577419654316238
Cellulitis, Cephalexin and TMP/SMX147131599999431245
Infected Wound, Clindamycin29918991112107441640
Infected Wound, TMP/SMX231117147101073524246

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Mean Days Missed From Normal Activities in the Per Protocol Population

As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. (NCT00729937)
Timeframe: Day 1 through 14

Interventiondays (Mean)
Abscess, Placebo2.6
Abscess, TMP/SMX2.0
Infected Wound, TMP/SMX2.7
Infected Wound, Clindamycin2.1
Cellulitis, Cephalexin and TMP/SMX2.2
Cellulitis, Cephalexin2.5

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Mean Days Missed From Normal Activities in the Intent to Treat Population

As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. (NCT00729937)
Timeframe: Day 1 through 14

Interventiondays (Mean)
Abscess, Placebo2.5
Abscess, TMP/SMX2.1
Infected Wound, TMP/SMX2.6
Infected Wound, Clindamycin2.1
Cellulitis, Cephalexin and TMP/SMX2.2
Cellulitis, Cephalexin2.7

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Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population

All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63

Interventionparticipants (Number)
Abscess, Placebo76
Abscess, TMP/SMX52
Infected Wound, TMP/SMX20
Infected Wound, Clindamycin12
Cellulitis, Cephalexin and TMP/SMX33
Cellulitis, Cephalexin31

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Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population

All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63

Interventionparticipants (Number)
Abscess, Placebo69
Abscess, TMP/SMX42
Infected Wound, TMP/SMX17
Infected Wound, Clindamycin8
Cellulitis, Cephalexin and TMP/SMX33
Cellulitis, Cephalexin20

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Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population

All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21

Interventionparticipants (Number)
Abscess, Placebo52
Abscess, TMP/SMX25
Infected Wound, TMP/SMX16
Infected Wound, Clindamycin9
Cellulitis, Cephalexin and TMP/SMX26
Cellulitis, Cephalexin28

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Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population

All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21

Interventionparticipants (Number)
Abscess, Placebo46
Abscess, TMP/SMX18
Infected Wound, TMP/SMX13
Infected Wound, Clindamycin6
Cellulitis, Cephalexin and TMP/SMX26
Cellulitis, Cephalexin17

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Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population

Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63

Interventionparticipants (Number)
Abscess, Placebo26
Abscess, TMP/SMX30
Infected Wound, TMP/SMX16
Infected Wound, Clindamycin6
Cellulitis, Cephalexin and TMP/SMX35
Cellulitis, Cephalexin31

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Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population

Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63

Interventionparticipants (Number)
Abscess, Placebo23
Abscess, TMP/SMX26
Infected Wound, TMP/SMX14
Infected Wound, Clindamycin4
Cellulitis, Cephalexin and TMP/SMX33
Cellulitis, Cephalexin24

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Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population

Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21

Interventionparticipants (Number)
Abscess, Placebo17
Abscess, TMP/SMX13
Infected Wound, TMP/SMX15
Infected Wound, Clindamycin4
Cellulitis, Cephalexin and TMP/SMX32
Cellulitis, Cephalexin29

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Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population

Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21

Interventionparticipants (Number)
Abscess, Placebo16
Abscess, TMP/SMX11
Infected Wound, TMP/SMX13
Infected Wound, Clindamycin3
Cellulitis, Cephalexin and TMP/SMX30
Cellulitis, Cephalexin22

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Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population

Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. (NCT00729937)
Timeframe: Day 1 through Day 49-63

Interventionparticipants (Number)
Abscess, Placebo3
Abscess, TMP/SMX2
Infected Wound, TMP/SMX0
Infected Wound, Clindamycin0
Cellulitis, Cephalexin and TMP/SMX1
Cellulitis, Cephalexin0

[back to top]

Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population

Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. (NCT00729937)
Timeframe: Day 1 through Day 49-63

Interventionparticipants (Number)
Abscess, Placebo2
Abscess, TMP/SMX2
Infected Wound, TMP/SMX0
Infected Wound, Clindamycin0
Cellulitis, Cephalexin and TMP/SMX1
Cellulitis, Cephalexin0

[back to top]

Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population

Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. (NCT00729937)
Timeframe: Day 1 through Day 14-21

Interventionparticipants (Number)
Abscess, Placebo1
Abscess, TMP/SMX1
Infected Wound, TMP/SMX0
Infected Wound, Clindamycin0
Cellulitis, Cephalexin and TMP/SMX0
Cellulitis, Cephalexin0

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Number of Participants Reporting Adverse Events That Are Treatment Limiting.

Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting. (NCT00730028)
Timeframe: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)

Interventionparticipants (Number)
Cellulitis or Larger Abscess - Clindamycin1
Cellulitis or Larger Abscess - TMP-SMX0
Limited Abscess - Clindamycin6
Limited Abscess - TMP-SMX3
Limited Abscess - Placebo4

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Number of Participants Reporting Adverse Events.

Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. (NCT00730028)
Timeframe: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)

Interventionparticipants (Number)
Cellulitis or Larger Abscess - Clindamycin116
Cellulitis or Larger Abscess - TMP-SMX132
Limited Abscess - Clindamycin119
Limited Abscess - TMP-SMX94
Limited Abscess - Placebo119

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Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.

Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure. (NCT00730028)
Timeframe: EOT visit within 48 hours of completion of therapy

Interventionpercentage of participants (Number)
Cellulitis or Larger Abscess - Clindamycin81.1
Cellulitis or Larger Abscess - TMP-SMX75.4
Limited Abscess - Clindamycin78.9
Limited Abscess - TMP-SMX79.8
Limited Abscess - Placebo72.4

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Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.

Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure. (NCT00730028)
Timeframe: EOT visit within 48 hours of completion of therapy

Interventionpercentage of participants (Number)
Cellulitis or Larger Abscess - Clindamycin89.2
Cellulitis or Larger Abscess - TMP-SMX88.3
Limited Abscess - Clindamycin90.9
Limited Abscess - TMP-SMX94.2
Limited Abscess - Placebo84.9

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Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.

Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure. (NCT00730028)
Timeframe: OMFU visit

Interventionpercentage of participants (Number)
Cellulitis or Larger Abscess - Clindamycin83.9
Cellulitis or Larger Abscess - TMP-SMX78.2
Limited Abscess - Clindamycin89.3
Limited Abscess - TMP-SMX85.0
Limited Abscess - Placebo73.9

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Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.

Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure. (NCT00730028)
Timeframe: OMFU visit

Interventionpercentage of participants (Number)
Cellulitis or Larger Abscess - Clindamycin73.1
Cellulitis or Larger Abscess - TMP-SMX67.7
Limited Abscess - Clindamycin78.6
Limited Abscess - TMP-SMX73.0
Limited Abscess - Placebo62.6

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Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.

"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit." (NCT00730028)
Timeframe: Test of cure (TOC) (7-10 days after completion of therapy)

Interventionpercentage of participants (Number)
Cellulitis or Larger Abscess - Clindamycin89.5
Cellulitis or Larger Abscess - TMP-SMX88.2
Limited Abscess - Clindamycin92.9
Limited Abscess - TMP-SMX92.7
Limited Abscess - Placebo80.5

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Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.

"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit." (NCT00730028)
Timeframe: Test of cure (TOC) (7-10 days after completion of therapy)

Interventionpercentage of participants (Number)
Cellulitis or Larger Abscess - Clindamycin80.3
Cellulitis or Larger Abscess - TMP-SMX77.7
Limited Abscess - Clindamycin83.1
Limited Abscess - TMP-SMX81.7
Limited Abscess - Placebo68.9

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Recurrence Rates of Abscesses

Number of patient with a new abscess in same or different location as previous lesion (NCT00822692)
Timeframe: 30 days after incision and drainage

Interventionparticipants (Number)
Bactrim DS (800/160) Two Tablets PO BID x 7 Days4
Matched Placebo 2 Pills PO BID x 7 Days14

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Clinical Improvement at 7 Days After Incision and Drainage

improving wound without evidence of fever, worsening cellulitis or induration (NCT00829686)
Timeframe: 7 days

Interventionparticipants (Number)
No Intervention10
Septra DS14

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Recurrence Rates

recurrence of abscess in previous or new location within 30 days (NCT00829686)
Timeframe: 30 days

Interventionparticipants (Number)
No Intervention1
Septra DS0

[back to top]

Health Outcomes After Use With Trimethoprim-sulfamethaxazole

(NCT00867789)
Timeframe: two years

InterventionPercentage of outcomes assessed (Number)
Trimethoprim-sulfamethaxazole0
Sugar Pill0

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Eradication of S. Aureus Colonization

Eradication was measured by performing cultures for S aureus at the nose, throat, and groin (NCT00869518)
Timeframe: 30 days following completion of treatment

Interventionparticipants (Number)
Rifabutin0
Placebo0

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Eradication of S. Aureus Colonization

Eradication was measured by performing cultures for S aureus at the nose, throat, and groin (NCT00869518)
Timeframe: 7 days following completion of treatment

Interventionparticipants (Number)
Rifabutin3
Placebo1

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Recurrent Skin and Skin Structure Infections (SSTI)

recurrent SSTI was by self-report and exam, followed until positive colonization (NCT00869518)
Timeframe: up to 30 days following completion of treatment

Interventionparticipants (Number)
Rifabutin0
Placebo0

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Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants

The primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria. (NCT00948896)
Timeframe: Randomization to 24 months of age

,,,
InterventionEpisodes per person year at risk (Number)
Randomization - 24 mo. of AgeRandomization -16 mo. of Age17-24 mo. of Age
HIV-exposed & Daily TS2.861.703.79
HIV-exposed & Monthly DP1.830.902.67
HIV-exposed & Monthly SP4.503.725.22
HIV-exposed & no Chemoprevention6.285.427.04

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Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants

The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6-24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria. (NCT00948896)
Timeframe: 6 to 24 months of age

,,,
InterventionEpisode per person year at risk (Number)
6-24 mo. of Age6-11 mo. of Age12-24 mo. of Age
HIV-unexposed & Daily TS5.213.276.32
HIV-unexposed & Monthly DP3.021.493.88
HIV-unexposed & Monthly SP6.735.517.41
HIV-unexposed & no Chemoprevention6.956.417.24

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Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk

(NCT00948896)
Timeframe: 24 months to 36 months of age

,,,,,,,
InterventionIncidence per person year at risk (Number)
All incident episodes of malariaComplicated malariaAll-cause hospital admissions
HIV-exposed & Daily TS8.130.1160.186
HIV-exposed & Monthly DP6.780.0440.089
HIV-exposed & Monthly SP6.750.1470.318
HIV-exposed & no Chemoprevention9.080.1610.459
HIV-unexposed & Daily TS10.900.0460.091
HIV-unexposed & Monthly DP10.7700.023
HIV-unexposed & Monthly SP11.980.1320.452
HIV-unexposed & no Chemoprevention10.850.0460.046

[back to top]

Treatment Failures at 7 Days

worsening abscess or new recurrence of abscess (NCT00973765)
Timeframe: 7 days

Interventionparticipants (Number)
Active Comparator15
Placebo27

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Number of Participants With Urinary Tract Infection

Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL (NCT01108757)
Timeframe: 7 days following catheter removal

InterventionParticipants (Count of Participants)
Drug6
Placebo6

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Elimination Rate Constants for Sulfamethoxazole and Trimethoprim

(NCT01167452)
Timeframe: 24 hours

Interventionhr-1 (Median)
Sulfamethoxazole0.060
Trimethoprim0.03

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Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI2808132
Doripenem26910939

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Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
Clinical cureClinical failure
CAZ-AVI3464
Doripenem3874

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Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI32745
Doripenem36821

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Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI31843
Doripenem35821

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Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI378510
Doripenem40755

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Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failure
CAZ-AVI23519
Doripenem25433

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Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI232154
Doripenem246242

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Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI226154
Doripenem236242

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Investigator Determined Clinical Response at LFU (mMITT Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI3352335
Doripenem3503928

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Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failure
CAZ-AVI2898
Doripenem30921

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Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI28345
Doripenem298130

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Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

,
InterventionParticipants (Number)
Number of patients with fever (>38°C) at baselineNumber afebrile at the time of the last obsNumber censored at the time of the last obs
CAZ-AVI1231221
Doripenem1181135

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Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

,
InterventionParticipants (Number)
Number of patients with fever (>38°C) at baselineNumber afebrile at the time of the last obsNumber censored at the time of the last obs
CAZ-AVI1241240
Doripenem1111083

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Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

,
InterventionParticipants (Number)
Number of patients with fever (>38°C) at baselineNumber afebrile at the time of the last obsNumber censored at the time of the last obs
CAZ-AVI1241240
Doripenem1081053

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Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)

Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

,
InterventionParticipants (Number)
Number of patients with fever (>38°C) at baselineNumber afebrile at the time of the last obsNumber censored at the time of the last obs
CAZ-AVI1571552
Doripenem1501437

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Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=4,4)E. coli (MIC: 0.015) - Favorable (n=5, 6)E. coli (MIC: 0.03) - Favorable (n=18, 21)E. coli (MIC: 0.06) - Favorable (n=95, 111)E. coli (MIC: 0.12) - Favorable (n=68, 54)E. coli (MIC: 0.25) - Favorable (n=19, 18)E. coli (MIC: 0.5) - Favorable (n=2, 5)E. coli (MIC: 1) - Favorable (n=2, 0)E. coli (MIC: 2) - Favorable (n=1, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: 32) - Favorable (n=0, 0)E. coli (MIC: >32) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4)Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)Entero. cloacae (MIC: 1)- Favorable (n= 1,4)Entero. cloacae (MIC: 2)- Favorable (n= 1,0)Entero. cloacae (MIC: 4)- Favorable (n= 2,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: 32)- Favorable (n= 0,0)Entero. cloacae (MIC: >32)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)P.aeruginosa (MIC: 1) - Favorable (n=1,4)P.aeruginosa (MIC: 2) - Favorable (n=4,5)P.aeruginosa (MIC: 4) - Favorable (n=5,6)P.aeruginosa (MIC: 8) - Favorable (n=2,2)P.aeruginosa (MIC: 16) - Favorable (n=0,1)P.aeruginosa (MIC: 32) - Favorable (n=0,0)P.aeruginosa (MIC: >32) - Favorable (n=1,0)
CAZ-AVI25178356132110000001147146200000019400000000000010100111000000000001411001
Doripenem4517944082000000000276283000001000400000000000001201400000000000002541100

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Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=32, 28)Klebsiella pneumoniae - Favorable (n=4, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI29311
Doripenem27202

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Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=19, 18)Klebsiella pneumoniae - Favorable (n=2, 1)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI19210
Doripenem17101

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Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=19, 18)Klebsiella pneumoniae - Favorable (n=2, 1)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI19210
Doripenem17101

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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=292, 306)Klebsiella pneumoniae - Favorable (n=44, 56)Proteus mirabilis - Favorable (n=17, 13)Enterobacter cloacae - Favorable (n= 11,13)Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI198321669
Doripenem189306913

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Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=4,4)E. coli (MIC: 0.015) - Favorable (n=5, 6)E. coli (MIC: 0.03) - Favorable (n=18, 21)E. coli (MIC: 0.06) - Favorable (n=95, 111)E. coli (MIC: 0.12) - Favorable (n=68, 54)E. coli (MIC: 0.25) - Favorable (n=19, 18)E. coli (MIC: 0.5) - Favorable (n=2, 5)E. coli (MIC: 1) - Favorable (n=2, 0)E. coli (MIC: 2) - Favorable (n=1, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: 32) - Favorable (n=0, 0)E. coli (MIC: >32) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4)Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)Entero. cloacae (MIC: 1)- Favorable (n= 1,4)Entero. cloacae (MIC: 2)- Favorable (n= 1,0)Entero. cloacae (MIC: 4)- Favorable (n= 2,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: 32)- Favorable (n= 0,0)Entero. cloacae (MIC: >32)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)P.aeruginosa (MIC: 1) - Favorable (n=1,4)P.aeruginosa (MIC: 2) - Favorable (n=4,4)P.aeruginosa (MIC: 4) - Favorable (n=3,4)P.aeruginosa (MIC: 8) - Favorable (n=1,1)P.aeruginosa (MIC: 16) - Favorable (n=0,0)P.aeruginosa (MIC: 32) - Favorable (n=0,0)P.aeruginosa (MIC: >32) - Favorable (n=0,0)
CAZ-AVI25178356132110000001147145200000019400000000000010100111000000000001411000
Doripenem4517944082000000000276283000000000400000000000001201400000000000002430000

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Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 30 to 90 minutes after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI47575.1

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Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 30 to 90 minutes after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI6587.2

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Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 300 to 360 minutes after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI1883.2

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Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=1,1)E. coli (MIC: 0.015) - Favorable (n=122, 119)E. coli (MIC: 0.03) - Favorable (n=79, 89)E. coli (MIC: 0.06) - Favorable (n=10, 8)E. coli (MIC: 0.12) - Favorable (n=1,2)E. coli (MIC: 0.25) - Favorable (n=1,0)E. coli (MIC: 0.5) - Favorable (n=0,0)E. coli (MIC: 1) - Favorable (n=0, 0)E. coli (MIC: 2) - Favorable (n=0, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: >16) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0)Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)Entero. cloacae (MIC: 1)- Favorable (n= 0,1)Entero. cloacae (MIC: 2)- Favorable (n= 0,0)Entero. cloacae (MIC: 4)- Favorable (n= 0,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: >16)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)P.aeruginosa (MIC: 1) - Favorable (n=1,3)P.aeruginosa (MIC: 2) - Favorable (n=1,0)P.aeruginosa (MIC: 4) - Favorable (n=0,0)P.aeruginosa (MIC: 8) - Favorable (n=0,0)P.aeruginosa (MIC: 16) - Favorable (n=0,0)P.aeruginosa (MIC: >16) - Favorable (n=0,0)
CAZ-AVI110664711000000001127211100000001246100000001110020000000002022010000
Doripenem19570310000000001186210000000000121000000001114001000000003211200000

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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=179, 194)Klebsiella pneumoniae - Favorable (n=30, 35)Proteus mirabilis - Favorable (n=11,5)Enterobacter cloacae - Favorable (n= 7, 11)Pseudomonas aeruginosa - Favorable (n=8, 13)
CAZ-AVI129231156
Doripenem12718188

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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=179, 198)Klebsiella pneumoniae - Favorable (n=31, 36)Proteus mirabilis - Favorable (n=11,5)Enterobacter cloacae - Favorable (n= 7, 11)Pseudomonas aeruginosa - Favorable (n=12, 16)
CAZ-AVI129241157
Doripenem13119189

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Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=32, 28)Klebsiella pneumoniae - Favorable (n=4, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI31211
Doripenem28202

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Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=26, 24)Klebsiella pneumoniae - Favorable (n=2, 1)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI26111
Doripenem24102

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Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=26, 24)Klebsiella pneumoniae - Favorable (n=2, 1)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI26111
Doripenem24102

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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=292, 306)Klebsiella pneumoniae - Favorable (n=44, 56)Proteus mirabilis - Favorable (n=17, 13)Enterobacter cloacae - Favorable (n= 11,13)Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI2804116917
Doripenem29351111318

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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=249, 270)Klebsiella pneumoniae - Favorable (n=33, 48)Proteus mirabilis - Favorable (n=13,11)Enterobacter cloacae - Favorable (n= 9, 12)Pseudomonas aeruginosa - Favorable (n=10, 15)
CAZ-AVI249331399
Doripenem27047111214

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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=250, 274)Klebsiella pneumoniae - Favorable (n=34, 49)Proteus mirabilis - Favorable (n=13, 11)Enterobacter cloacae - Favorable (n= 9, 12)Pseudomonas aeruginosa - Favorable (n=18, 18)
CAZ-AVI2503413917
Doripenem27448111217

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Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01595438)
Timeframe: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.

,
InterventionParticipants (Number)
Symptomatic resolutionSymptom persistenceIndeterminate
CAZ-AVI27610314
Doripenem27612417

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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
All patients - Clinical cure (n=75, 84)Escherichia coli patients - Clin cure (n=36, 37)Klebsiella pneumoniae patients-Clin cure(n=18,30)Pseudomonas aeruginosa patients- Clin cure(n=7,6)Enterobacter cloacae patients-Clin cure(n=7,6)Proteus mirabilis patients - Clin cure (n=2, 5)
CAZ-AVI673317552
Doripenem753128655

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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
All patients - Clinical cure (n=48, 57)Escherichia coli patients-Clin cure (n=23,27)Klebsiella pneumoniae patients-Clin cure(n=14, 22)Pseudomonas aeruginosa patients-Clin cure(n=1, 2)Enterobacter cloacae patients-Clin cure(n=5,5)Proteus mirabilis patients - Clin cure (n=0, 2)
CAZ-AVI472214150
Doripenem552522252

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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
All patients - Clinical cure (n=51, 63)Escherichia coli patients - Clin cure (n=23, 27)Klebsiella pneumoniae patients-Clin cure(n=15, 23)Pseudomonas aeruginosa patients-Clin cure(n=3,6)Enterobacter cloacae patients-Clin cure(n=5,5)Proteus mirabilis patients - Clin cure (n=0, 2)
CAZ-AVI502215350
Doripenem612523652

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Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: within 15 minutes before/after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI9307.3

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Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=32, 28)Klebsiella pneumoniae - Favorable (n=4, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI31311
Doripenem28202

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Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 300 to 360 minutes after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI16959.6

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Investigator Determined Clinical Response at TOC (mMITT Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI3551127
Doripenem3772416

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Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI27745
Doripenem285130

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Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: within 15 minutes before/after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI65481.2

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Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=1,1)E. coli (MIC: 0.015) - Favorable (n=122, 119)E. coli (MIC: 0.03) - Favorable (n=79, 89)E. coli (MIC: 0.06) - Favorable (n=10, 8)E. coli (MIC: 0.12) - Favorable (n=1, 2)E. coli (MIC: 0.25) - Favorable (n=1, 0)E. coli (MIC: 0.5) - Favorable (n=0, 0)E. coli (MIC: 1) - Favorable (n=0, 0)E. coli (MIC: 2) - Favorable (n=0, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: >16) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0)Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)Entero. cloacae (MIC: 1)- Favorable (n= 0,1)Entero. cloacae (MIC: 2)- Favorable (n= 0,0)Entero. cloacae (MIC: 4)- Favorable (n= 0,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: >16)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)P.aeruginosa (MIC: 1) - Favorable (n=1,3)P.aeruginosa (MIC: 2) - Favorable (n=1,0)P.aeruginosa (MIC: 4) - Favorable (n=0,2)P.aeruginosa (MIC: 8) - Favorable (n=1,1)P.aeruginosa (MIC: 16) - Favorable (n=2,1)P.aeruginosa (MIC: >16) - Favorable (n=1,1)
CAZ-AVI110664711000000001127211100001001246100000001110020000000002022010001
Doripenem19570310000000001186210000100000121000000001114001000000003211201111

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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=214, 226)Klebsiella pneumoniae - Favorable (n=32, 42)Proteus mirabilis - Favorable (n=14, 7)Enterobacter cloacae - Favorable (n= 7, 11)Pseudomonas aeruginosa - Favorable (n=13, 18)
CAZ-AVI180261458
Doripenem176294813

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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=214, 221)Klebsiella pneumoniae - Favorable (n=31, 41)Proteus mirabilis - Favorable (n=14, 7)Enterobacter cloacae - Favorable (n= 7, 11)Pseudomonas aeruginosa - Favorable (n=9, 13)
CAZ-AVI180251457
Doripenem17128489

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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=292, 306)Klebsiella pneumoniae - Favorable (n=44, 56)Proteus mirabilis - Favorable (n=17, 13)Enterobacter cloacae - Favorable (n= 11,13)Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI2293316612
Doripenem220359915

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Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=22, 20)Klebsiella pneumoniae - Favorable (n=2, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI22210
Doripenem20201

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Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=22, 20)Klebsiella pneumoniae - Favorable (n=2, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI22210
Doripenem20201

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Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=5, 6)E. coli (MIC: 0.015) - Favorable (n=8, 7)E. coli (MIC: 0.03) - Favorable (n=28, 35)E. coli (MIC: 0.06) - Favorable (n=123, 139)E. coli (MIC: 0.12) - Favorable (n=90, 81)E. coli (MIC: 0.25) - Favorable (n=28, 25)E. coli (MIC: 0.5) - Favorable (n=5, 6)E. coli (MIC: 1) - Favorable (n=3, 0)E. coli (MIC: 2) - Favorable (n=1, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: 32) - Favorable (n=0, 0)E. coli (MIC: >32) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16)Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5)Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1)Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5)Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6)Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2)Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4)Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)Entero. cloacae (MIC: 1)- Favorable (n= 2,5)Entero. cloacae (MIC: 2)- Favorable (n= 1,0)Entero. cloacae (MIC: 4)- Favorable (n= 2,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: 32)- Favorable (n= 0,0)Entero. cloacae (MIC: >32)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)P.aeruginosa (MIC: 0.5) - Favorable (n=0,2)P.aeruginosa (MIC: 1) - Favorable (n=1,4)P.aeruginosa (MIC: 2) - Favorable (n=5,5)P.aeruginosa (MIC: 4) - Favorable (n=7,6)P.aeruginosa (MIC: 8) - Favorable (n=2,2)P.aeruginosa (MIC: 16) - Favorable (n=1,1)P.aeruginosa (MIC: 32) - Favorable (n=0,0)P.aeruginosa (MIC: >32) - Favorable (n=2,0)
CAZ-AVI3824103671841100000011791662000000110500000000000010200111000000000001531002
Doripenem5623111541320000000002873113000001003500100000000001211400000000000022541100

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Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI3351
Doripenem3692

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Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)

Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI3241
Doripenem3592

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Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=1, 3)E. coli (MIC: 0.015) - Favorable (n=160, 160)E. coli (MIC: 0.03) - Favorable (n=112, 123)E. coli (MIC: 0.06) - Favorable (n=14, 10)E. coli (MIC: 0.12) - Favorable (n=3, 3)E. coli (MIC: 0.25) - Favorable (n=1, 0)E. coli (MIC: 0.5) - Favorable (n=0,0)E. coli (MIC: 1) - Favorable (n=0, 0)E. coli (MIC: 2) - Favorable (n=0, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: >16) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3)Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27)Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1)Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1)Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5)Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4)Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5)Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1)Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0)Entero. cloacae (MIC: 1)- Favorable (n= 0,1)Entero. cloacae (MIC: 2)- Favorable (n= 0,0)Entero. cloacae (MIC: 4)- Favorable (n= 0,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: >16)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)P.aeruginosa (MIC: 0.12) - Favorable (n=2,2)P.aeruginosa (MIC: 0.25) - Favorable (n=2,5)P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)P.aeruginosa (MIC: 1) - Favorable (n=1,4)P.aeruginosa (MIC: 2) - Favorable (n=1,0)P.aeruginosa (MIC: 4) - Favorable (n=2,2)P.aeruginosa (MIC: 8) - Favorable (n=2,1)P.aeruginosa (MIC: 16) - Favorable (n=2,1)P.aeruginosa (MIC: >16) - Favorable (n=2,1)
CAZ-AVI11278910110000000011610211100001001256200000002110020000000002122011102
Doripenem311986420000000002217220000100000142200000001214001000000003221301111

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Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI18467
Doripenem17399

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Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI18263
Doripenem16696

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Per-patient Microbiological Response at LFU (mMITT Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI2688342
Doripenem25412538

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Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)

Number of patients with a favorable per patient microbiological response at TOC (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI24349
Doripenem23675

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Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)

Number of patients with a favorable per patient microbiological response at TOC (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI24145
Doripenem22573

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Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI3045831
Doripenem2968338

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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI3714
Doripenem4122

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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI3513
Doripenem3720

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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI47199
Doripenem51276

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Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)

Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI374118
Doripenem395319

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Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI3351
Doripenem3692

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Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)

Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI3241
Doripenem3592

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Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)

Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI374118
Doripenem395319

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Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI18467
Doripenem17399

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Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI18263
Doripenem16696

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Per-patient Microbiological Response at LFU (mMITT Analysis Set)

Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI2688342
Doripenem25412538

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Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)

Number of patients with a favorable per patient microbiological response at TOC (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI24349
Doripenem23675

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Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)

Number of patients with a favorable per patient microbiological response at TOC (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI24145
Doripenem22573

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Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI3045831
Doripenem2968338

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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI3714
Doripenem4122

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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorable
CAZ-AVI3513
Doripenem3720

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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI47199
Doripenem51276

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Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

,
InterventionParticipants (Number)
Number of patients with fever (>38°C) at baselineNumber afebrile at the time of the last obsNumber censored at the time of the last obs
CAZ-AVI1231221
Doripenem1181135

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Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

,
InterventionParticipants (Number)
Number of patients with fever (>38°C) at baselineNumber afebrile at the time of the last obsNumber censored at the time of the last obs
CAZ-AVI1241240
Doripenem1111083

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Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)

Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

,
InterventionParticipants (Number)
Number of patients with fever (>38°C) at baselineNumber afebrile at the time of the last obsNumber censored at the time of the last obs
CAZ-AVI1241240
Doripenem1081053

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Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)

Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.

,
InterventionParticipants (Number)
Number of patients with fever (>38°C) at baselineNumber afebrile at the time of the last obsNumber censored at the time of the last obs
CAZ-AVI1571552
Doripenem1501437

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Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI226154
Doripenem236242

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Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 30 to 90 minutes after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI6587.2

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Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 300 to 360 minutes after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI1883.2

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Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: within 15 minutes before/after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI9307.3

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Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 30 to 90 minutes after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI47575.1

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Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 300 to 360 minutes after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI16959.6

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Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)

Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: within 15 minutes before/after dose

InterventionNG/ML (Geometric Mean)
CAZ-AVI65481.2

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Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
FavorableUnfavorableIndeterminate
CAZ-AVI2808132
Doripenem26910939

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Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
Clinical cureClinical failure
CAZ-AVI3464
Doripenem3874

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Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI32745
Doripenem36821

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Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI31843
Doripenem35821

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Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)

Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI378510
Doripenem40755

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Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failure
CAZ-AVI23519
Doripenem25433

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Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI232154
Doripenem246242

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Investigator Determined Clinical Response at LFU (mMITT Analysis Set)

Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI3352335
Doripenem3503928

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Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failure
CAZ-AVI2898
Doripenem30921

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Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI28345
Doripenem298130

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Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI27745
Doripenem285130

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Investigator Determined Clinical Response at TOC (mMITT Analysis Set)

Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminate
CAZ-AVI3551127
Doripenem3772416

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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
All patients - Clinical cure (n=51, 63)Escherichia coli patients - Clin cure (n=23, 27)Klebsiella pneumoniae patients-Clin cure(n=15, 23)Pseudomonas aeruginosa patients-Clin cure(n=3,6)Enterobacter cloacae patients-Clin cure(n=5,5)Proteus mirabilis patients - Clin cure (n=0, 2)
CAZ-AVI502215350
Doripenem612523652

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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
All patients - Clinical cure (n=48, 57)Escherichia coli patients-Clin cure (n=23,27)Klebsiella pneumoniae patients-Clin cure(n=14, 22)Pseudomonas aeruginosa patients-Clin cure(n=1, 2)Enterobacter cloacae patients-Clin cure(n=5,5)Proteus mirabilis patients - Clin cure (n=0, 2)
CAZ-AVI472214150
Doripenem552522252

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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)

Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipants (Number)
All patients - Clinical cure (n=75, 84)Escherichia coli patients - Clin cure (n=36, 37)Klebsiella pneumoniae patients-Clin cure(n=18,30)Pseudomonas aeruginosa patients- Clin cure(n=7,6)Enterobacter cloacae patients-Clin cure(n=7,6)Proteus mirabilis patients - Clin cure (n=2, 5)
CAZ-AVI673317552
Doripenem753128655

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Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test

Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01599806)
Timeframe: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.

,
InterventionParticipants (Number)
Symptomatic resolutionSymptom persistenceIndeterminate
CAZ-AVI27610314
Doripenem27612417

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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=250, 274)Klebsiella pneumoniae - Favorable (n=34, 49)Proteus mirabilis - Favorable (n=13, 11)Enterobacter cloacae - Favorable (n= 9, 12)Pseudomonas aeruginosa - Favorable (n=18, 18)
CAZ-AVI2503413917
Doripenem27448111217

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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=249, 270)Klebsiella pneumoniae - Favorable (n=33, 48)Proteus mirabilis - Favorable (n=13,11)Enterobacter cloacae - Favorable (n= 9, 12)Pseudomonas aeruginosa - Favorable (n=10, 15)
CAZ-AVI249331399
Doripenem27047111214

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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=292, 306)Klebsiella pneumoniae - Favorable (n=44, 56)Proteus mirabilis - Favorable (n=17, 13)Enterobacter cloacae - Favorable (n= 11,13)Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI2804116917
Doripenem29351111318

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Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=26, 24)Klebsiella pneumoniae - Favorable (n=2, 1)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI26111
Doripenem24102

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Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=26, 24)Klebsiella pneumoniae - Favorable (n=2, 1)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI26111
Doripenem24102

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Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=32, 28)Klebsiella pneumoniae - Favorable (n=4, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI31211
Doripenem28202

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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=179, 198)Klebsiella pneumoniae - Favorable (n=31, 36)Proteus mirabilis - Favorable (n=11,5)Enterobacter cloacae - Favorable (n= 7, 11)Pseudomonas aeruginosa - Favorable (n=12, 16)
CAZ-AVI129241157
Doripenem13119189

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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=179, 194)Klebsiella pneumoniae - Favorable (n=30, 35)Proteus mirabilis - Favorable (n=11,5)Enterobacter cloacae - Favorable (n= 7, 11)Pseudomonas aeruginosa - Favorable (n=8, 13)
CAZ-AVI129231156
Doripenem12718188

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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=292, 306)Klebsiella pneumoniae - Favorable (n=44, 56)Proteus mirabilis - Favorable (n=17, 13)Enterobacter cloacae - Favorable (n= 11,13)Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI198321669
Doripenem189306913

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Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=19, 18)Klebsiella pneumoniae - Favorable (n=2, 1)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI19210
Doripenem17101

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Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=19, 18)Klebsiella pneumoniae - Favorable (n=2, 1)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI19210
Doripenem17101

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Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=32, 28)Klebsiella pneumoniae - Favorable (n=4, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI29311
Doripenem27202

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Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=4,4)E. coli (MIC: 0.015) - Favorable (n=5, 6)E. coli (MIC: 0.03) - Favorable (n=18, 21)E. coli (MIC: 0.06) - Favorable (n=95, 111)E. coli (MIC: 0.12) - Favorable (n=68, 54)E. coli (MIC: 0.25) - Favorable (n=19, 18)E. coli (MIC: 0.5) - Favorable (n=2, 5)E. coli (MIC: 1) - Favorable (n=2, 0)E. coli (MIC: 2) - Favorable (n=1, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: 32) - Favorable (n=0, 0)E. coli (MIC: >32) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4)Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)Entero. cloacae (MIC: 1)- Favorable (n= 1,4)Entero. cloacae (MIC: 2)- Favorable (n= 1,0)Entero. cloacae (MIC: 4)- Favorable (n= 2,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: 32)- Favorable (n= 0,0)Entero. cloacae (MIC: >32)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)P.aeruginosa (MIC: 1) - Favorable (n=1,4)P.aeruginosa (MIC: 2) - Favorable (n=4,5)P.aeruginosa (MIC: 4) - Favorable (n=5,6)P.aeruginosa (MIC: 8) - Favorable (n=2,2)P.aeruginosa (MIC: 16) - Favorable (n=0,1)P.aeruginosa (MIC: 32) - Favorable (n=0,0)P.aeruginosa (MIC: >32) - Favorable (n=1,0)
CAZ-AVI25178356132110000001147146200000019400000000000010100111000000000001411001
Doripenem4517944082000000000276283000001000400000000000001201400000000000002541100

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Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=4,4)E. coli (MIC: 0.015) - Favorable (n=5, 6)E. coli (MIC: 0.03) - Favorable (n=18, 21)E. coli (MIC: 0.06) - Favorable (n=95, 111)E. coli (MIC: 0.12) - Favorable (n=68, 54)E. coli (MIC: 0.25) - Favorable (n=19, 18)E. coli (MIC: 0.5) - Favorable (n=2, 5)E. coli (MIC: 1) - Favorable (n=2, 0)E. coli (MIC: 2) - Favorable (n=1, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: 32) - Favorable (n=0, 0)E. coli (MIC: >32) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11)Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4)Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2)Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5)Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3)Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)Entero. cloacae (MIC: 1)- Favorable (n= 1,4)Entero. cloacae (MIC: 2)- Favorable (n= 1,0)Entero. cloacae (MIC: 4)- Favorable (n= 2,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: 32)- Favorable (n= 0,0)Entero. cloacae (MIC: >32)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)P.aeruginosa (MIC: 0.5) - Favorable (n=0,0)P.aeruginosa (MIC: 1) - Favorable (n=1,4)P.aeruginosa (MIC: 2) - Favorable (n=4,4)P.aeruginosa (MIC: 4) - Favorable (n=3,4)P.aeruginosa (MIC: 8) - Favorable (n=1,1)P.aeruginosa (MIC: 16) - Favorable (n=0,0)P.aeruginosa (MIC: 32) - Favorable (n=0,0)P.aeruginosa (MIC: >32) - Favorable (n=0,0)
CAZ-AVI25178356132110000001147145200000019400000000000010100111000000000001411000
Doripenem4517944082000000000276283000000000400000000000001201400000000000002430000

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Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)

Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=5, 6)E. coli (MIC: 0.015) - Favorable (n=8, 7)E. coli (MIC: 0.03) - Favorable (n=28, 35)E. coli (MIC: 0.06) - Favorable (n=123, 139)E. coli (MIC: 0.12) - Favorable (n=90, 81)E. coli (MIC: 0.25) - Favorable (n=28, 25)E. coli (MIC: 0.5) - Favorable (n=5, 6)E. coli (MIC: 1) - Favorable (n=3, 0)E. coli (MIC: 2) - Favorable (n=1, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: 32) - Favorable (n=0, 0)E. coli (MIC: >32) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16)Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5)Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1)Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5)Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6)Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0)Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: 32)- Favorable (n=0, 0)Proteus mirabilis (MIC: >32)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0)Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2)Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4)Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1)Entero. cloacae (MIC: 1)- Favorable (n= 2,5)Entero. cloacae (MIC: 2)- Favorable (n= 1,0)Entero. cloacae (MIC: 4)- Favorable (n= 2,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: 32)- Favorable (n= 0,0)Entero. cloacae (MIC: >32)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=0,0)P.aeruginosa (MIC: 0.12) - Favorable (n=0,0)P.aeruginosa (MIC: 0.25) - Favorable (n=0,0)P.aeruginosa (MIC: 0.5) - Favorable (n=0,2)P.aeruginosa (MIC: 1) - Favorable (n=1,4)P.aeruginosa (MIC: 2) - Favorable (n=5,5)P.aeruginosa (MIC: 4) - Favorable (n=7,6)P.aeruginosa (MIC: 8) - Favorable (n=2,2)P.aeruginosa (MIC: 16) - Favorable (n=1,1)P.aeruginosa (MIC: 32) - Favorable (n=0,0)P.aeruginosa (MIC: >32) - Favorable (n=2,0)
CAZ-AVI3824103671841100000011791662000000110500000000000010200111000000000001531002
Doripenem5623111541320000000002873113000001003500100000000001211400000000000022541100

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Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=1,1)E. coli (MIC: 0.015) - Favorable (n=122, 119)E. coli (MIC: 0.03) - Favorable (n=79, 89)E. coli (MIC: 0.06) - Favorable (n=10, 8)E. coli (MIC: 0.12) - Favorable (n=1, 2)E. coli (MIC: 0.25) - Favorable (n=1, 0)E. coli (MIC: 0.5) - Favorable (n=0, 0)E. coli (MIC: 1) - Favorable (n=0, 0)E. coli (MIC: 2) - Favorable (n=0, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: >16) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0)Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)Entero. cloacae (MIC: 1)- Favorable (n= 0,1)Entero. cloacae (MIC: 2)- Favorable (n= 0,0)Entero. cloacae (MIC: 4)- Favorable (n= 0,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: >16)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)P.aeruginosa (MIC: 1) - Favorable (n=1,3)P.aeruginosa (MIC: 2) - Favorable (n=1,0)P.aeruginosa (MIC: 4) - Favorable (n=0,2)P.aeruginosa (MIC: 8) - Favorable (n=1,1)P.aeruginosa (MIC: 16) - Favorable (n=2,1)P.aeruginosa (MIC: >16) - Favorable (n=1,1)
CAZ-AVI110664711000000001127211100001001246100000001110020000000002022010001
Doripenem19570310000000001186210000100000121000000001114001000000003211201111

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Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=1,1)E. coli (MIC: 0.015) - Favorable (n=122, 119)E. coli (MIC: 0.03) - Favorable (n=79, 89)E. coli (MIC: 0.06) - Favorable (n=10, 8)E. coli (MIC: 0.12) - Favorable (n=1,2)E. coli (MIC: 0.25) - Favorable (n=1,0)E. coli (MIC: 0.5) - Favorable (n=0,0)E. coli (MIC: 1) - Favorable (n=0, 0)E. coli (MIC: 2) - Favorable (n=0, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: >16) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2)Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23)Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0)Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2)Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3)Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4)Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0)Entero. cloacae (MIC: 1)- Favorable (n= 0,1)Entero. cloacae (MIC: 2)- Favorable (n= 0,0)Entero. cloacae (MIC: 4)- Favorable (n= 0,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: >16)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)P.aeruginosa (MIC: 0.12) - Favorable (n=1,2)P.aeruginosa (MIC: 0.25) - Favorable (n=2,4)P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)P.aeruginosa (MIC: 1) - Favorable (n=1,3)P.aeruginosa (MIC: 2) - Favorable (n=1,0)P.aeruginosa (MIC: 4) - Favorable (n=0,0)P.aeruginosa (MIC: 8) - Favorable (n=0,0)P.aeruginosa (MIC: 16) - Favorable (n=0,0)P.aeruginosa (MIC: >16) - Favorable (n=0,0)
CAZ-AVI110664711000000001127211100000001246100000001110020000000002022010000
Doripenem19570310000000001186210000000000121000000001114001000000003211200000

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Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)

Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
E. coli (MIC: <=0.008) - Favorable (n=1, 3)E. coli (MIC: 0.015) - Favorable (n=160, 160)E. coli (MIC: 0.03) - Favorable (n=112, 123)E. coli (MIC: 0.06) - Favorable (n=14, 10)E. coli (MIC: 0.12) - Favorable (n=3, 3)E. coli (MIC: 0.25) - Favorable (n=1, 0)E. coli (MIC: 0.5) - Favorable (n=0,0)E. coli (MIC: 1) - Favorable (n=0, 0)E. coli (MIC: 2) - Favorable (n=0, 0)E. coli (MIC: 4) - Favorable (n=0, 0)E. coli (MIC: 8) - Favorable (n=0, 0)E. coli (MIC: 16) - Favorable (n=0, 0)E. coli (MIC: >16) - Favorable (n=0, 0)Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0)Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3)Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27)Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16)Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4)Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3)Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1)Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0)Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0)Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0)Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1)Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1)Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0)Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0)Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0)Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2)Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5)Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4)Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2)Proteus mirabilis (MIC: 1)- Favorable (n=0, 0)Proteus mirabilis (MIC: 2)- Favorable (n=0, 0)Proteus mirabilis (MIC: 4)- Favorable (n=0, 0)Proteus mirabilis (MIC: 8)- Favorable (n=0, 0)Proteus mirabilis (MIC: 16)- Favorable (n=0, 0)Proteus mirabilis (MIC: >16)- Favorable (n=0, 0)Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0)Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1)Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5)Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1)Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4)Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1)Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0)Entero. cloacae (MIC: 1)- Favorable (n= 0,1)Entero. cloacae (MIC: 2)- Favorable (n= 0,0)Entero. cloacae (MIC: 4)- Favorable (n= 0,0)Entero. cloacae (MIC: 8)- Favorable (n= 0,0)Entero. cloacae (MIC: 16)- Favorable (n= 0,0)Entero. cloacae (MIC: >16)- Favorable (n= 0,0)P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0)P.aeruginosa (MIC: 0.015) - Favorable (n=0,0)P.aeruginosa (MIC: 0.03) - Favorable (n=0,0)P.aeruginosa (MIC: 0.06) - Favorable (n=2,3)P.aeruginosa (MIC: 0.12) - Favorable (n=2,2)P.aeruginosa (MIC: 0.25) - Favorable (n=2,5)P.aeruginosa (MIC: 0.5) - Favorable (n=2,1)P.aeruginosa (MIC: 1) - Favorable (n=1,4)P.aeruginosa (MIC: 2) - Favorable (n=1,0)P.aeruginosa (MIC: 4) - Favorable (n=2,2)P.aeruginosa (MIC: 8) - Favorable (n=2,1)P.aeruginosa (MIC: 16) - Favorable (n=2,1)P.aeruginosa (MIC: >16) - Favorable (n=2,1)
CAZ-AVI11278910110000000011610211100001001256200000002110020000000002122011102
Doripenem311986420000000002217220000100000142200000001214001000000003221301111

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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=214, 226)Klebsiella pneumoniae - Favorable (n=32, 42)Proteus mirabilis - Favorable (n=14, 7)Enterobacter cloacae - Favorable (n= 7, 11)Pseudomonas aeruginosa - Favorable (n=13, 18)
CAZ-AVI180261458
Doripenem176294813

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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=214, 221)Klebsiella pneumoniae - Favorable (n=31, 41)Proteus mirabilis - Favorable (n=14, 7)Enterobacter cloacae - Favorable (n= 7, 11)Pseudomonas aeruginosa - Favorable (n=9, 13)
CAZ-AVI180251457
Doripenem17128489

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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=292, 306)Klebsiella pneumoniae - Favorable (n=44, 56)Proteus mirabilis - Favorable (n=17, 13)Enterobacter cloacae - Favorable (n= 11,13)Pseudomonas aeruginosa - Favorable (n=18, 20)
CAZ-AVI2293316612
Doripenem220359915

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Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=22, 20)Klebsiella pneumoniae - Favorable (n=2, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI22210
Doripenem20201

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Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=22, 20)Klebsiella pneumoniae - Favorable (n=2, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=0, 1)
CAZ-AVI22210
Doripenem20201

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Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)

Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization

,
InterventionParticipant (Number)
Escherichia coli - Favorable (n=32, 28)Klebsiella pneumoniae - Favorable (n=4, 2)Proteus mirabilis - Favorable (n=1, 0)Pseudomonas aeruginosa - Favorable (n=1, 2)
CAZ-AVI31311
Doripenem28202

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CD4 Cell Count

Number of Participants with at Least One CD4 Count <200 (NCT01650558)
Timeframe: Every 6 months for 22-66 months

InterventionParticipants (Count of Participants)
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis24
Chloroquine (CQ) Prophylaxis23
Discontinuation of Standard of Care (Control Arm)27

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Severe Events

Incidence of severe events (composite of death and WHO stage 3 and 4 illness) (NCT01650558)
Timeframe: 22-66 months

InterventionEvents per 100 participant-years (Number)
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis3.3
Chloroquine (CQ) Prophylaxis4.2
Discontinuation of Standard of Care (Control Arm)4.2

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Number of Participants With at Least One Detectable HIV Viral Load

Number of participants who ever have a detectable viral load (>400 copies/ml). (NCT01650558)
Timeframe: Throughout study participation, measured every six months (2-5.5 years).

InterventionParticipants (Count of Participants)
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis24
Chloroquine (CQ) Prophylaxis36
Discontinuation of Standard of Care (Control Arm)33

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Bacterial Infections and Malaria

Incidence of bacterial infections and malaria (NCT01650558)
Timeframe: 32-66 months

InterventionEvents per 100 participant-years (Number)
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis27.8
Chloroquine (CQ) Prophylaxis37.4
Discontinuation of Standard of Care (Control Arm)36.3

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WHO HIV Stage 2, 3, 4 Illness

Incidence of any WHO HIV stage 2, 3, or 4 illness (NCT01650558)
Timeframe: 32-66 months

InterventionEvents per 100 participant-years (Number)
Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis4.0
Chloroquine (CQ) Prophylaxis5.7
Discontinuation of Standard of Care (Control Arm)5.8

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Number of Participants With Post-biopsy Infection.

To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB. This measure is number of participants with post-biopsy infection. (NCT01659866)
Timeframe: 30 days post-biopsy

Interventionparticipants (Number)
Cipro-susceptible6
Cipro-resistant3

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Recurrent Skin Infections

Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. (NCT02024867)
Timeframe: 1 month after surgical drainage

Interventionparticipants (Number)
3 Days21
10 Days9

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Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus

Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. (NCT02024867)
Timeframe: up to 2 weeks after surgical drainage

Interventionparticipants (Number)
3 Days1
10 Days1

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Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus

Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. (NCT02024867)
Timeframe: 1 month after surgical drainage

Interventionparticipants (Number)
3 Days8
10 Days2

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Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus

Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. (NCT02024867)
Timeframe: up to 2 weeks after surgical drainage

Interventionparticipants (Number)
3 Days8
10 Days1

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Treatment Failures

Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. (NCT02024867)
Timeframe: up to 2 weeks after surgical drainage

Interventionparticipants (Number)
3 Days9
10 Days4

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Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus

Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. (NCT02024867)
Timeframe: 1 month after surgical drainage

Interventionparticipants (Number)
3 Days7
10 Days7

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Cotrimoxazole: New Clinical and Diagnostic Positive Malaria

Number of participants with a new clinical and diagnostic positive malaria, to be analysed using time-to-event methods. Diagnostic positive by either microscopy (thick film) or rapid diagnostic test (RDT) (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis39
Stopped Cotrimoxazole Prophylaxis77

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Cotrimoxazole: New Severe Pneumonia

Number of participants with a new severe pneumonia, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis7
Stopped Cotrimoxazole Prophylaxis10

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Cotrimoxazole: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis8
Stopped Cotrimoxazole Prophylaxis19

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Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea

Number of participants with a new WHO stage 3 severe recurrent pneumonia or diarrhoea, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis1
Stopped Cotrimoxazole Prophylaxis4

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Cotrimoxazole: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis4
Stopped Cotrimoxazole Prophylaxis7

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Cotrimoxazole: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis-0.01
Stopped Cotrimoxazole Prophylaxis-0.05

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Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation

(NCT02028676)
Timeframe: Baseline, 72 weeks

Interventionpercentage of total lymphocytes (Mean)
Arm A: ABC+3TC+NNRTI16.4
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance17.1
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance17.3

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Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation

(NCT02028676)
Timeframe: Baseline, 144 weeks

Interventionpercentage of total lymphocytes (Mean)
Arm A: ABC+3TC+NNRTI19.8
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance19.6
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance19.2

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Induction ART: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Arm A: ABC+3TC+NNRTI30
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance28
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance28

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LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Intervention% of visits reporting missed pills (Mean)
Clinically Driven Monitoring (CDM)8.5
Laboratory Plus Clinical Monitoring (LCM)9.4
Arm A: ABC+3TC+NNRTI8.3
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance9.5
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance9.1

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LCM vs CDM, Induction ART: All-cause Mortality

Number of participants who died from any cause, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)25
Laboratory Plus Clinical Monitoring (LCM)29
Arm A: ABC+3TC+NNRTI20
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance14
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance20

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Cotrimoxazole: New Hospitalisation or Death

Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis48
Stopped Cotrimoxazole Prophylaxis72

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LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.65
Laboratory Plus Clinical Monitoring (LCM)0.61
Arm A: ABC+3TC+NNRTI0.56
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.64
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.69

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LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure

Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)28
Laboratory Plus Clinical Monitoring (LCM)35

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LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 144

Interventionabsolute cells per mm3 (Mean)
Clinically Driven Monitoring (CDM)418
Laboratory Plus Clinical Monitoring (LCM)420
Arm A: ABC+3TC+NNRTI446
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance450
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance360

[back to top]

LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 72

Interventionabsolute cells per mm3 (Mean)
Clinically Driven Monitoring (CDM)408
Laboratory Plus Clinical Monitoring (LCM)385
Arm A: ABC+3TC+NNRTI402
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance447
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance336

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LCM vs CDM, Induction ART: Height-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.36
Laboratory Plus Clinical Monitoring (LCM)0.43
Arm A: ABC+3TC+NNRTI0.40
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.40
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.38

[back to top]

LCM vs CDM, Induction ART: New ART-modifying Adverse Event

Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)31
Laboratory Plus Clinical Monitoring (LCM)32
Arm A: ABC+3TC+NNRTI8
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance30
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance25

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LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death

Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)91
Laboratory Plus Clinical Monitoring (LCM)79
Arm A: ABC+3TC+NNRTI64
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance53
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance53

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LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)77
Laboratory Plus Clinical Monitoring (LCM)73
Arm A: ABC+3TC+NNRTI73
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance61
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance54

[back to top]

LCM vs CDM, Induction ART: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.76
Laboratory Plus Clinical Monitoring (LCM)0.78
Arm A: ABC+3TC+NNRTI0.72
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.79
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.80

[back to top]

LCM vs CDM: Change From Baseline in CD4% to Week 144

(NCT02028676)
Timeframe: Baseline, week 144

Interventionpercentage of total lymphocytes (Mean)
Clinically Driven Monitoring (CDM)19.7
Laboratory Plus Clinical Monitoring (LCM)19.4

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LCM vs CDM: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Clinically Driven Monitoring (CDM)17.2
Laboratory Plus Clinical Monitoring (LCM)16.7

[back to top]

LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death

Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)47
Laboratory Plus Clinical Monitoring (LCM)39

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Mean over median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Intervention% of visits reporting missed pills (Mean)
Once-daily ABC+3TC8
Twice-daily ABC+3TC8

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks

Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 48 weeks. (NCT02028676)
Timeframe: 48 weeks after randomization to once- versus twice-daily

Interventionparticipants (Number)
Once-daily ABC+3TC32
Twice-daily ABC+3TC29

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks

Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 96 weeks. (NCT02028676)
Timeframe: 96 weeks after randomization to once- versus twice-daily

Interventionparticipants (Number)
Once-daily ABC+3TC26
Twice-daily ABC+3TC25

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality

Number of participants who died, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC1
Twice-daily ABC+3TC4

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 48

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC3
Twice-daily ABC+3TC-3

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72

All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured (NCT02028676)
Timeframe: Baseline, week 72

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC-6
Twice-daily ABC+3TC27

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96

All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured (NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 96

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC-26
Twice-daily ABC+3TC60

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48

(NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 48

Interventionpercentage of total lymphocytes (Mean)
Once-daily ABC+3TC0.9
Twice-daily ABC+3TC1.3

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Once-daily ABC+3TC1.9
Twice-daily ABC+3TC1.9

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96

(NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 96

Interventionpercentage of lymphocytes (Mean)
Once-daily ABC+3TC1.6
Twice-daily ABC+3TC2.5

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score

Age-adjusted change in height-for-age Z-score over all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC0.28
Twice-daily ABC+3TC0.32

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Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC9
Twice-daily ABC+3TC12

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC3
Twice-daily ABC+3TC7

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Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation

Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression. (NCT02028676)
Timeframe: 48 weeks

Interventionparticipants (Number)
Once-daily ABC+3TC236
Twice-daily ABC+3TC242

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Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation

Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 96 weeks

Interventionparticipants (Number)
Once-daily ABC+3TC230
Twice-daily ABC+3TC234

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC0.01
Twice-daily ABC+3TC-0.00

[back to top]

Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC-0.29
Twice-daily ABC+3TC-0.35

[back to top]

CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline

Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 144 weeks

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)192
Laboratory Plus Clinical Monitoring (LCM)193
Arm A: ABC+3TC+NNRTI127
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance135
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance124

[back to top]

CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline

Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 72 weeks

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)76
Laboratory Plus Clinical Monitoring (LCM)78
Arm A: ABC+3TC+NNRTI56
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance72
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance26

[back to top]

Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Intervention% of visits reporting missed pills (Mean)
Continued Cotrimoxazole Prophylaxis9
Stopped Cotrimoxazole Prophylaxis8

[back to top]

Cotrimoxazole: All-cause Mortality

Number of participants who died, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis3
Stopped Cotrimoxazole Prophylaxis2

[back to top]

Cotrimoxazole: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis-0.24
Stopped Cotrimoxazole Prophylaxis-0.28

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Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72

Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 72

Interventioncells per mm3 (Mean)
Continued Cotrimoxazole Prophylaxis7
Stopped Cotrimoxazole Prophylaxis-2

[back to top]

Cotrimoxazole: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Continued Cotrimoxazole Prophylaxis1.7
Stopped Cotrimoxazole Prophylaxis1.1

[back to top]

Cotrimoxazole: Height-for-age Z-score

Age-adjusted change in height-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis0.22
Stopped Cotrimoxazole Prophylaxis0.19

[back to top]

Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score

Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score (0 - 1 range). A lower score indicates a better health score. The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people. (NCT02759120)
Timeframe: Randomization to 12 months

InterventionScores on a scale (Mean)
Antimicrobial Therapy Plus Standard of Care0.027
Standard of Care0.017

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Change in Leicester Cough Questionnaire Score

Leicester Cough Questionnaire score (3 - 21 range). A higher score indicates a better health score. The Leicester Cough Questionnaire measures quality of life in people with a chronic cough. (NCT02759120)
Timeframe: Randomization to 12 months

InterventionScores on a scale (Mean)
Antimicrobial Therapy Plus Standard of Care-0.58
Standard of Care-0.58

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Change in SF-12 Health Survey (SF-12) Mental Score

"Change in short form-12 health survey (SF-12) mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score.~The short form-12 health survey (SF-12) mental component summary (MCS) assesses general mental health." (NCT02759120)
Timeframe: Randomization to 12 months

InterventionScores on a scale (Mean)
Antimicrobial Therapy Plus Standard of Care-1.29
Standard of Care-1.59

[back to top]

Change in Short Form-12 Health Survey (SF-12) 6D Score

Change in Short Form-12 health survey (SF-12) 6D score (0.29 - 1.00 range). A higher indicates a better health score. The SF-12 6D score provides and economic evaluation. (NCT02759120)
Timeframe: Randomization to 12 months

InterventionScores on a scale (Mean)
Antimicrobial Therapy Plus Standard of Care-0.013
Standard of Care-0.031

[back to top]

Change in Short Form-12 Health Survey (SF-12) Physical Score

"Change in short form-12 health survey (SF-12) physical component summary (PSC) score (0 - 100 range). A higher score indicates a better health score.~The short form-12 health survey physical score assesses limitations in physical activities because of health problems." (NCT02759120)
Timeframe: Randomization to 12 months

InterventionScores on a scale (Mean)
Antimicrobial Therapy Plus Standard of Care-1.36
Standard of Care-1.88

[back to top]

Change in UCSD-Shortness of Breath Questionnaire

Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (0 - 120 range). A lower score indicates a better health score. The UCSD-Shortness of Breath Questionnaire assesses the severity of shortness of breath during specific activities of daily living. (NCT02759120)
Timeframe: Randomization to 12 months

InterventionScores on a scale (Mean)
Antimicrobial Therapy Plus Standard of Care5.67
Standard of Care6.29

[back to top]

Number of Participants With Death From Any Cause

(NCT02759120)
Timeframe: Randomization to up to 35 months

InterventionParticipants (Count of Participants)
Antimicrobial Therapy Plus Standard of Care37
Standard of Care37

[back to top]

Number of Participants With First Non-elective, All-cause Hospitalization

(NCT02759120)
Timeframe: Randomization to up to 35 months

InterventionParticipants (Count of Participants)
Antimicrobial Therapy Plus Standard of Care54
Standard of Care47

[back to top]

Number of Participants With First Non-elective, Respiratory Hospitalization

(NCT02759120)
Timeframe: Randomization to up to 35 months

InterventionParticipants (Count of Participants)
Antimicrobial Therapy Plus Standard of Care36
Standard of Care31

[back to top]

Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality

(NCT02759120)
Timeframe: Randomization to up to 35 months

InterventionParticipants (Count of Participants)
Antimicrobial Therapy Plus Standard of Care52
Standard of Care56

[back to top]

Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)

(NCT02759120)
Timeframe: Randomization to 12 months

Interventionpercent change (Mean)
Antimicrobial Therapy Plus Standard of Care-1.72
Standard of Care-2.56

[back to top]

Percent Change in Forced Vital Capacity (FVC)

(NCT02759120)
Timeframe: Randomization to 12 months

Interventionpercent change (Mean)
Antimicrobial Therapy Plus Standard of Care-2.99
Standard of Care-4.13

[back to top]

Total Number of Non-elective All-cause Hospitalizations

(NCT02759120)
Timeframe: Randomization to up to 35 months

Interventionhospitalizations (Number)
Antimicrobial Therapy Plus Standard of Care72
Standard of Care52

[back to top]

Total Number of Non-elective Respiratory Hospitalizations

(NCT02759120)
Timeframe: Randomization to up to 35 months

Interventionhospitalizations (Number)
Antimicrobial Therapy Plus Standard of Care55
Standard of Care43

[back to top]

Total Number of Respiratory Infections

(NCT02759120)
Timeframe: Randomization to up to 35 months

Interventionrespiratory infections (Number)
Antimicrobial Therapy Plus Standard of Care34
Standard of Care49

[back to top]

Change in EuroQol Index (EQ-5D) Score

European Quality of Life-5 dimensions (EQ-5D) score (0 - 1 range). A higher score indicates a better health score. The EQ-5D measures quality of life across 5 dimensions (1. Mobility, 2. Self-care, 3. Usual activities, 4. Pain/discomfort, 5. Anxiety/depression. (NCT02759120)
Timeframe: Randomization to 12 months

InterventionScores on a scale (Mean)
Antimicrobial Therapy Plus Standard of Care-0.040
Standard of Care-0.046

[back to top]

Change in Fatigue Severity Scale Score

Fatigue Severity Scale score (1 - 7 range). A lower score indicates a better health score. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle. (NCT02759120)
Timeframe: Randomization to 12 months

InterventionScores on a scale (Mean)
Antimicrobial Therapy Plus Standard of Care0.24
Standard of Care0.13

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Height-for-age Z-score

Nutritional status as determined by height-for-age Z-score Height-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Height-for-age Z (HAZ) score were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately stunted (HAZ). A cutoff of < -3 means severely stunted (HAZ). (NCT03187834)
Timeframe: Day 35

Interventionz score (Mean)
Children who received Placebo
Placebo-0.59

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Height-for-age Z-score

Nutritional status as determined by height-for-age Z-score Height-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Height-for-age Z (HAZ) score were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately stunted (HAZ). A cutoff of < -3 means severely stunted (HAZ). (NCT03187834)
Timeframe: Day 35

,,
Interventionz score (Mean)
Children who received AntibioticChildren who received Placebo
Amoxicillin-0.80-0.73
Azithromycin-0.92-1.16
Cotrimoxazole-0.69-1.38

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L1-norm Distance on Bacterial Reads (Intestinal)

L1-norm distance on bacterial reads (intestinal) - L1 norm is equivalent to Shannon's diversity. Shannon's Alpha Diversity combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances. (NCT03187834)
Timeframe: Baseline and Day 9 (Post- Treatment)

,,,
InterventionIndex score (Mean)
BaselinePost-treatment
Amoxicillin16.613.9
Azithromycin14.611.0
Cotrimoxazole15.613.5
Placebo15.416.0

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L2-norm Distance on Bacterial Reads (Intestinal)

L2-norm distance on bacterial reads (intestinal) - L2 norm is equivalent to Simpson's diversity. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales. (NCT03187834)
Timeframe: Baseline and Day 9 (Post- Treatment)

,,,
InterventionIndex score (Mean)
BaselinePost-treatment
Amoxicillin10.28.3
Azithromycin8.86.6
Cotrimoxazole9.78.3
Placebo9.69.8

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Mid-upper Arm Circumference

"Nutritional status as determined by mid-upper arm circumference in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Mid-upper arm circumference (MUAC) in each antibiotic group compared with placebo 4 weeks after last antibiotic dose.~MUAC is a measure to assess nutritional status. It is measured on a straight left arm, mid-way between the tip of the shoulder and the tip of the elbow. It identifies acute malnutrition and is commonly used in children 6-59 months of age as well as pregnant women. MUAC less than 115 mm indicates severe wasting or severe acute malnutrition (SAM). MUAC greater than or equal to 115 mm and less than 125 mm indicates moderate wasting or moderate acute malnutrition (MAM)." (NCT03187834)
Timeframe: Day 35

Interventionmm (Mean)
Children who received Placebo
Placebo15.23

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Mid-upper Arm Circumference

"Nutritional status as determined by mid-upper arm circumference in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Mid-upper arm circumference (MUAC) in each antibiotic group compared with placebo 4 weeks after last antibiotic dose.~MUAC is a measure to assess nutritional status. It is measured on a straight left arm, mid-way between the tip of the shoulder and the tip of the elbow. It identifies acute malnutrition and is commonly used in children 6-59 months of age as well as pregnant women. MUAC less than 115 mm indicates severe wasting or severe acute malnutrition (SAM). MUAC greater than or equal to 115 mm and less than 125 mm indicates moderate wasting or moderate acute malnutrition (MAM)." (NCT03187834)
Timeframe: Day 35

,,
Interventionmm (Mean)
Children who received AntibioticChildren who received Placebo
Amoxicillin15.0114.90
Azithromycin14.5315.15
Cotrimoxazole15.4914.83

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Shannon's Index of Diversity (Alpha Diversity) in Intestinal Microbiome

Shannon's Alpha Diversity at Baseline and Post-treatment. combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances. (NCT03187834)
Timeframe: Baseline and Day 9 (Post- Treatment)

,,,
InterventionIndex score (Mean)
BaselinePost-treatment
Amoxicillin16.613.9
Azithromycin14.611.0
Cotrimoxazole15.613.5
Placebo15.416.0

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Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome

The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales. (NCT03187834)
Timeframe: Baseline and Day 9

,,,
InterventionIndex score (Mean)
BaselinePost-treatment
Amoxicillin10.28.3
Azithromycin8.86.6
Cotrimoxazole9.78.3
Placebo9.69.8

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Weight-for-age Z-score

Nutritional status as determined by weight-for-age Z-score vs. Placebo household Weight-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-age Z-score (WAZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately underweight (WAZ). A cutoff of < -3 means severely underweight (WAZ). (NCT03187834)
Timeframe: Day 35

InterventionZ score (Mean)
Children who received Placebo
Placebo-0.53

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Weight-for-age Z-score

Nutritional status as determined by weight-for-age Z-score vs. Placebo household Weight-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-age Z-score (WAZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately underweight (WAZ). A cutoff of < -3 means severely underweight (WAZ). (NCT03187834)
Timeframe: Day 35

,,
InterventionZ score (Mean)
Children who received AntibioticChildren who received Placebo
Amoxicillin-0.60-0.78
Azithromycin-1.01-0.78
Cotrimoxazole-0.58-1.12

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Weight-for-height Z-score

Nutritional status as determined by weight-for-height Z-score vs. Placebo household Weight-for-height Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-height Z (WHZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately wasted (WHZ). A cutoff of < -3 means wasted (WHZ). (NCT03187834)
Timeframe: Day 35

Interventionz score (Mean)
Children who received Placebo
Placebo-0.28

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Weight-for-height Z-score

Nutritional status as determined by weight-for-height Z-score vs. Placebo household Weight-for-height Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-height Z (WHZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately wasted (WHZ). A cutoff of < -3 means wasted (WHZ). (NCT03187834)
Timeframe: Day 35

,,
Interventionz score (Mean)
Children who received AntibioticChildren who received Placebo
Amoxicillin-0.24-0.52
Azithromycin-0.71-0.17
Cotrimoxazole-0.27-0.49

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Number of Participants With Macrolide Resistance Genes

Prevalence of macrolide resistance genes measured using DNA-seq from rectal swabs. (NCT03187834)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Azithromycin Households12
Placebo Households9

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Proportion With Adverse Birth Outcomes

Composite measure: low infant birthweight (<2500 grams), miscarriage (<28 weeks), preterm delivery (<37 weeks), small for gestational age (SGA), congenital anomaly detected on surface examination, early neonatal mortality (within 7 days of birth) (NCT03431168)
Timeframe: Birth outcomes will be measured at birth for all outcomes except early neonatal mortality defined as within 7 days of birth. Early neonatal mortality will be assessed at a six week follow up phone call.

InterventionParticipants (Count of Participants)
Azithromycin/TMPS13
Placebo/TMPS20

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Proportion of Participants With Symptomatic Malaria

Fever and positive malaria test (rapid diagnostic test) at routine visits or sick call visits or maternal report of malaria diagnosis. (NCT03431168)
Timeframe: From the date of randomization until the time of delivery, assessed up to 42 weeks.

InterventionParticipants (Count of Participants)
Azithromycin/TMPS13
Placebo/TMPS13

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Plasmodium Falciparum Peripheral Parasitemia

P. falciparum detected by microscopy or polymerase chain reaction (PCR) (NCT03431168)
Timeframe: At end of pregnancy (>35 weeks) or at delivery

InterventionParticipants (Count of Participants)
Azithromycin/TMPS8
Placebo/TMPS7

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Maternal Adherence to the Prophylactic Regimen

Directly observed therapy (DOT) in clinic for the 1st dose of study medication. Self-report and pill count will be used to assess adherence and maternal tolerability for study medications taken at home from the time of enrollment until delivery. At each follow up visit and at delivery, participants will complete a medication adherence survey. They will self-report adherence to the 3 day study regimen (AZ or placebo). (NCT03431168)
Timeframe: Adherence of study medication taken at home will be documented from the date of randomization until the time of delivery, assessed up to 42 weeks.

InterventionParticipants (Count of Participants)
Azithromycin/TMPS148
Placebo/TMPS148

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Low Birthweight (<2500 Grams)

Neonatal weight measured with digital scale (NCT03431168)
Timeframe: at birth

InterventionParticipants (Count of Participants)
Azithromycin/TMPS4
Placebo/TMPS7

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GBS Colonization

anogenital GBS colonization detected by NAAT (PCR) (NCT03431168)
Timeframe: at or near term or at delivery

InterventionParticipants (Count of Participants)
Azithromycin/TMPS8
Placebo/TMPS7

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Composite STI Measure (Including All STI Tests)

Proportion of women with GC/CT (by NAAT), syphilis (by serology), Mycoplasma genitalium (NAAT). (NCT03431168)
Timeframe: After 35 weeks GA or at delivery

InterventionParticipants (Count of Participants)
Azithromycin/TMPS5
Placebo/TMPS5

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Proportion With Placental Malaria

Placentas will be collected on a subset of women and impression smear will be used to assess for malaria infection (NCT03431168)
Timeframe: At delivery

InterventionParticipants (Count of Participants)
Azithromycin/TMPS7
Placebo/TMPS5

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Proportion With Maternal Anemia and Severe Maternal Anemia

anemia defined as hemoglobin <11 g/dL, severe anemia defined as hemoglobin <7 g/dL. (NCT03431168)
Timeframe: At the end of pregnancy (>35 weeks) or at delivery

InterventionParticipants (Count of Participants)
Azithromycin/TMPS2
Placebo/TMPS2

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Proportion With Composite STI Outcome

Including chlamydia (NAAT (nucleic acid amplification test) positive) , gonorrhea (NAAT positive), syphilis (non-treponemal and treponemal test positive) infections. (NCT03431168)
Timeframe: will be measured in both groups (>35 weeks) or at delivery

InterventionParticipants (Count of Participants)
Azithromycin/TMPS2
Placebo/TMPS2

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Time to Return to Baseline Oxygen for the Current AECOPD

Time to return to baseline oxygenation for the index exacerbation measured in days (NCT05418777)
Timeframe: up to 3 months

Interventiondays (Mean)
TMP-SMX0

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Number of Urgent Care Visits (Total)

Total number of urgent care visits following the index exacerbation (NCT05418777)
Timeframe: up to 3 months

Interventionnumber of visits (Mean)
TMP-SMX0

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Number of Urgent Care Visits (Related to COPD)

Number of urgent care visits related to COPD following the index exacerbation (NCT05418777)
Timeframe: up to 3 months

Interventionnumber of visits (Mean)
TMP-SMX0

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Number of Hospital Admissions (Total)

Total number of hospital admissions following the index exacerbation (NCT05418777)
Timeframe: up to 3 months

Interventionnumber of visits (Mean)
TMP-SMX1

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Number of Hospital Admissions (Related to COPD)

Number of hospital admissions related to COPD following the index exacerbation (NCT05418777)
Timeframe: up to 3 months

Interventionnumber of visits (Mean)
TMP-SMX1

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Need for Medications to Treat COPD

Number of medications used to treat COPD (NCT05418777)
Timeframe: up to 3 months

Interventionnumber of medications (Mean)
TMP-SMX5

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Need for Mechanical Ventilation

Number of participants who required mechanical ventilation (NCT05418777)
Timeframe: up to 3 months

InterventionParticipants (Count of Participants)
TMP-SMX0

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Mortality

Number of participants who died (NCT05418777)
Timeframe: up to 3 months

InterventionParticipants (Count of Participants)
TMP-SMX0

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Interval Between Exacerbations of COPD

Time between exacerbation of COPD measured in days (NCT05418777)
Timeframe: up to 3 months

Interventiondays (Mean)
Baseline to 1st exacerbation1st exacerbation to 2nd exacerbation
TMP-SMX337

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Interval Between Hospital Admissions

Time before next admission to the hospital measured in days (NCT05418777)
Timeframe: up to 3 months

Interventiondays (Mean)
TMP-SMX40

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Change in the COPD Assessment Test

Change in total score on the COPD Assessment Test (CAT); the test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcomes and a higher score means a worse outcome. Negative numbers indicate improvement of condition. Positive numbers indicate worsening of condition. (NCT05418777)
Timeframe: Baseline to 3 months

Interventionnumber on a scale (Mean)
Baseline to Day 10Baseline to Day 30Baseline to Day 90
TMP-SMX-10-6-2

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Length of Stay for Current AECOPD

Length of stay in the hospital for index exacerbation measured in days (NCT05418777)
Timeframe: up to 3 months

Interventionnumbers of days (Mean)
TMP-SMX5

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Clearance of PJ From Treated Patients

Number of patients that show clearance of PJ (NCT05418777)
Timeframe: up to 3 months

InterventionParticipants (Count of Participants)
TMP-SMX1

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Durability of Clearance of PJ From Treated Patients

Number of patients who cleared PJ and did not show re-colonization with pathogen (NCT05418777)
Timeframe: up to 3 months

InterventionParticipants (Count of Participants)
TMP-SMX1

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