fidaxomicin profile

Fidaxomicin: A narrow-spectrum macrolide antibacterial agent that is used in the treatment of diarrhea associated with CLOSTRIDIUM DIFFICILE INFECTION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

fidaxomicin : An 18-membered macrolide that is a fermentation product obtained from the Actinomycete Dactylosporangium aurantiacum. A narrow spectrum antibiotic used for treatment of Clostridium difficile-related infections. [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]

ID Source	ID
PubMed CID	10034073
CHEMBL ID	1255800
CHEBI ID	68590
SCHEMBL ID	10000818
MeSH ID	M0055551

Synonym
clostomicin b1
lipiarmycin a 3
lipiarmicin
brn 5228707
clostomycin b1
fidaxomicin
tiacumicin b
par-101
dificid
opt-80
difimicin
dificlir
873857-62-6
CHEMBL1255800
r-tiacumicin b
unii-z5n076g8yq
par 01
z5n076g8yq ,
fidaxomicin [usan:inn]
CHEBI:68590 ,
fidaxomicin [usan]
fidaxomicin [jan]
fidaxomicin [orange book]
fidaxomicin [who-dd]
lipiarrmycin
fidaxomicin [inn]
DB08874
fidaxomicin [vandf]
fidaxomicin [mi]
SCHEMBL10000818
F1216
56645-60-4
(2r,3s,4s,5s,6r)-6-{[(3e,5e,8s,9e,11s,12r,13e,15e,18s)-12-{[(2r,3s,4r,5s)-3,4-dihydroxy-6,6-dimethyl-5-[(2-methylpropanoyl)oxy]oxan-2-yl]oxy}-11-ethyl-8-hydroxy-18-[(1r)-1-hydroxyethyl]-9,13,15-trimethyl-2-oxo-1-oxacyclooctadeca-3,5,9,13,15-pentaen-3-yl]m
fidaxomicin, >=98% (hplc)
fidaxomicin (dificid)
fi8 ,
Q5446672
opt-80;par-101;clostomicin b1;tiacumicin b
DTXSID901016415 ,
gtpl10909
[(2r,3s,4s,5s,6r)-6-[[(3e,5e,8s,9e,11s,12r,13e,15e,18s)-12-[(2r,3s,4r,5s)-3,4-dihydroxy-6,6-dimethyl-5-(2-methylpropanoyloxy)oxan-2-yl]oxy-11-ethyl-8-hydroxy-18-[(1r)-1-hydroxyethyl]-9,13,15-trimethyl-2-oxo-1-oxacyclooctadeca-3,5,9,13,15-pentaen-3-yl]meth
EN300-21995976
dtxcid801474599
fidaxomicinum
fidaxomicine
(3e,5e,8s,9e,11s,12r,13e,15e,18s)-3-(((6-deoxy-4-o-(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)-2-o-methyl-beta-d-mannopyranosyl)oxy)methyl)-12-((6-deoxy-5-c-methyl-4-o-(2-methylpropanoyl)-beta-d-lyxo-hexopyranosyl)oxy)-11-ethyl-8-hydroxy-18-((1r)-1-hydrox
fidaxomicina
a07aa12
AKOS040758974

Excerpt	Reference	Relevance
" There were no differences in the incidence of death or serious adverse events between the 2 drugs."	( Safety analysis of fidaxomicin in comparison with oral vancomycin for Clostridium difficile infections. Allgren, RL; Sellers, S; Weiss, K, 2012)	0.38
" The possibly study drug-related adverse events were diarrhea (n = 1), feeling hot (n = 1), and hypersomnia (n = 2), which were mild in severity."	( Comparison of the safety, tolerability, and pharmacokinetics of fidaxomicin in healthy Japanese and caucasian subjects. Benner, L; Kaibara, A; Michon, I; Miki, T; Mujais, S; Oshima, H; Wojtkowski, T; Yamazaki, T, 2015)	0.42
" Fidaxomicin was safe and well-tolerated in all subjects."	( Comparison of the safety, tolerability, and pharmacokinetics of fidaxomicin in healthy Japanese and caucasian subjects. Benner, L; Kaibara, A; Michon, I; Miki, T; Mujais, S; Oshima, H; Wojtkowski, T; Yamazaki, T, 2015)	0.42
" Adverse event incidences and profiles were similar for both treatments."	( Efficacy and safety of fidaxomicin for the treatment of Clostridioides (Clostridium) difficile infection in a randomized, double-blind, comparative Phase III study in Japan. Gamo, K; Hashimoto, A; Kato, K; Kusachi, S; Mikamo, H; Miki, T; Oizumi, Y; Takesue, Y; Tateda, K; Toyoshima, J; Yanagihara, K, 2018)	0.48
" Sixty percent (15/25) of patients experienced treatment-emergent adverse events (TEAEs), none of which led to treatment discontinuation or death."	( Pharmacokinetics and safety of fidaxomicin in patients with inflammatory bowel disease and Clostridium difficile infection: an open-label Phase IIIb/IV study (PROFILE). Adomakoh, N; Gargalianos-Kakolyris, P; Georgopali, A; Högenauer, C; Ivashkin, V; Karas, A; Mahida, Y; Marteau, P; Michon, I; Reinisch, W; Rydzewska, G; Stallmach, A; Tretter, R, 2018)	0.48
" Safety assessments included treatment-emergent adverse events."	( Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE). Bosis, S; Bradford, D; Croos-Dabrera, R; Fortuny, C; Incera, E; Kalocsai, K; Korczowski, B; Lazar, S; Melis, J; Petit, A; van Maanen, R; Wolf, J, 2020)	0.56
" The proportion of participants with treatment-emergent adverse events was similar with fidaxomicin (73."	( Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE). Bosis, S; Bradford, D; Croos-Dabrera, R; Fortuny, C; Incera, E; Kalocsai, K; Korczowski, B; Lazar, S; Melis, J; Petit, A; van Maanen, R; Wolf, J, 2020)	0.56

Excerpt	Reference	Relevance
" Plasma and fecal samples were collected for pharmacokinetic assessments."	( Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial. Hoffenberg, EJ; Kaplan, SL; Kim, KS; Kociolek, LK; Michaels, MG; Nachman, S; O'Gorman, MA; Otley, A; Pfefferkorn, MD; Sears, P; Sentongo, T; Sullivan, JE, 2018)	0.48
"Fidaxomicin was well tolerated in children with CDAD and has a pharmacokinetic profile in children similar to that in adults."	( Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial. Hoffenberg, EJ; Kaplan, SL; Kim, KS; Kociolek, LK; Michaels, MG; Nachman, S; O'Gorman, MA; Otley, A; Pfefferkorn, MD; Sears, P; Sentongo, T; Sullivan, JE, 2018)	0.48
"Median Tmax of fidaxomicin and OP-1118 for the PK analysis set (PKAS; 24 patients) was 1-2 h across Days 1, 5 and 10."	( Pharmacokinetics and safety of fidaxomicin in patients with inflammatory bowel disease and Clostridium difficile infection: an open-label Phase IIIb/IV study (PROFILE). Adomakoh, N; Gargalianos-Kakolyris, P; Georgopali, A; Högenauer, C; Ivashkin, V; Karas, A; Mahida, Y; Marteau, P; Michon, I; Reinisch, W; Rydzewska, G; Stallmach, A; Tretter, R, 2018)	0.48
" However, the pharmacokinetic profile of fidaxomicin in an EPFX regimen is unknown."	( Pharmacokinetic analysis of an extended-pulsed fidaxomicin regimen for the treatment of Clostridioides (Clostridium) difficile infection in patients aged 60 years and older in the EXTEND randomized controlled trial. Cornely, OA; Georgopali, A; Guery, B; Karas, A; Kazeem, G; Michon, I; Wilcox, MH, 2020)	0.56
"Plasma samples from 14 patients were included in the pharmacokinetic analysis; 12 of these patients provided stool samples."	( Pharmacokinetic analysis of an extended-pulsed fidaxomicin regimen for the treatment of Clostridioides (Clostridium) difficile infection in patients aged 60 years and older in the EXTEND randomized controlled trial. Cornely, OA; Georgopali, A; Guery, B; Karas, A; Kazeem, G; Michon, I; Wilcox, MH, 2020)	0.56

Excerpt	Reference	Relevance
"Data from two retrospective cohorts of 'real-life' use of fidaxomicin and bezlotoxumab in combination with a standard anti-C."	( Fidaxomicin monotherapy versus standard therapy combined with bezlotoxumab for treating patients with Clostridioides difficile infection at high risk of recurrence: a matched cohort study. Armiñanzas Castillo, C; Cano Yuste, A; Cobo Reinoso, J; De La Torre Cisneros, J; Díaz Pollán, B; Escudero-Sanchez, R; Fernández Fradejas, J; García Basas, L; García Fernández, S; Giner, L; Gutierrez Rojas, A; Gutiérrez, B; López Medrano, F; Martín Segarra, O; Merino De Lucas, E; Muriel García, A; Olmedo Sampedrio, M; Ramos Martínez, A; Rodríguez Hernández, MJ; Rodríguez-Pardo, D; Ruíz Ruigomez, M; Sáez Bejar, C; Salavert Lletí, M; Tasias Pitarch, M; Valencia Alijo, A, 2022)	0.72

Excerpt	Reference	Relevance
" Tiacumicin B is also a potent inhibitor of Mycobacterium tuberculosis, but due to its limited oral bioavailability is unsuitable for systemic therapy."	( Total synthesis of the tiacumicin B (lipiarmycin A3/fidaxomicin) aglycone. Altmann, KH; Glaus, F, 2015)	0.42

Excerpt	Relevance	Reference
" The apparent high clinical response, good tolerance, low recurrence rate, and more-complete and rapid symptom control with the highest dosage support the selection of the 200-mg twice-daily dose for further clinical development of OPT-80 for treatment of CDI."	( Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection. Donskey, C; Goldstein, EJ; Louie, T; Miller, M; Mullane, K, 2009)	0.35
"The pharmacology, clinical efficacy, safety, dosage and administration, and place in therapy of fidaxomicin for the treatment of Clostridium difficile infection (CDI) are reviewed."	( Fidaxomicin: a novel macrocyclic antibiotic for the treatment of Clostridium difficile infection. Crawford, T; Danziger, L; Huesgen, E, 2012)	0.38
" The recommended dosage for treatment of CDI is fidaxomicin 200 mg orally twice daily for 10 days."	( Fidaxomicin: a novel macrocyclic antibiotic for the treatment of Clostridium difficile infection. Crawford, T; Danziger, L; Huesgen, E, 2012)	0.38
" difficile BI1, treatment with SMT19969, vancomycin and fidaxomicin resulted in 100% survival during the 5 day dosing period, with 90%-100% of animals receiving SMT19969 and fidaxomicin surviving during the post-dosing follow-up period."	( SMT19969 for Clostridium difficile infection (CDI): in vivo efficacy compared with fidaxomicin and vancomycin in the hamster model of CDI. Payne, L; Sattar, A; Thommes, P; Vickers, RJ; Warn, P, 2015)	0.42
"After multiple 200 mg dosing of fidaxomicin, both mean maximum plasma concentrations (C max) in Japanese (8."	( Comparison of the safety, tolerability, and pharmacokinetics of fidaxomicin in healthy Japanese and caucasian subjects. Benner, L; Kaibara, A; Michon, I; Miki, T; Mujais, S; Oshima, H; Wojtkowski, T; Yamazaki, T, 2015)	0.42
" Dosing began within 2 days of starting conditioning or fluoroquinolone prophylaxis and continued until 7 days after neutrophil engraftment or completion of fluoroquinolone prophylaxis/clinically-indicated antimicrobials for up to 40 days."	( A Randomized, Placebo-controlled Trial of Fidaxomicin for Prophylaxis of Clostridium difficile-associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation. Adachi, JA; Alexander, BD; Broyde, N; Dubberke, ER; Dugan, MJ; Gorbach, SL; Gregg, K; Holland, H; Morris, MI; Mullane, KM; Nooka, A; Pergam, SA; Sears, PS; Stiff, P; Winston, DJ, 2019)	0.51
"We obtained US antibiotic prescription data (IQVIA) from 2006-August 2019 and used guideline-recommended dosing regimens to estimate monthly numbers of 10-day treatment courses of vancomycin, fidaxomicin and metronidazole."	( Impact of Revised Infectious Diseases Society of America and Society for Healthcare Epidemiology of America Clinical Practice Guidelines on the Treatment of Clostridium difficile Infections in the United States. Buehrle, D; Clancy, CJ; Nguyen, MH; Vu, M; Wagener, MM, 2021)	0.62
" The aim of the present study is to investigate the in vivo efficacy of auranofin (rheumatoid arthritis FDA-approved drug) in a CDI mouse model and establish an adequate dosage for treatment."	( Auranofin, at clinically achievable dose, protects mice and prevents recurrence from Clostridioides difficile infection. Abutaleb, NS; Seleem, MN, 2020)	0.56
" Extended-pulsed dosing of fidaxomicin was associated with lower recurrence rates in one clinical trial but has never been directly compared with conventional fidaxomicin dosing."	( Conventional versus extended-pulsed fidaxomicin dosing in patients at high risk of recurrence of Clostridioides difficile infection: a propensity score analysis. Braojos Sánchez, F; Cobo, J; Del Campo Albendea, L; Diaz Gago, Á; Escudero-Sánchez, R; Halperin, A; Moreno Guillén, S; Muriel, A; Ponce Alonso, M; Rubio Martín, E; Vizcarra, P, 2023)	0.91
"To compare the recurrence rate of fidaxomicin conventional dosing (FCD) and fidaxomicin in extended-pulsed dosing (FEPD) in conditions of clinical practice at a single institution."	( Conventional versus extended-pulsed fidaxomicin dosing in patients at high risk of recurrence of Clostridioides difficile infection: a propensity score analysis. Braojos Sánchez, F; Cobo, J; Del Campo Albendea, L; Diaz Gago, Á; Escudero-Sánchez, R; Halperin, A; Moreno Guillén, S; Muriel, A; Ponce Alonso, M; Rubio Martín, E; Vizcarra, P, 2023)	0.91
"Although the recurrence rate with FEPD was numerically lower than that observed with FCD, we have not been able to show that the recurrence rate of CDI is different depending on the dosage regimen of fidaxomicin."	( Conventional versus extended-pulsed fidaxomicin dosing in patients at high risk of recurrence of Clostridioides difficile infection: a propensity score analysis. Braojos Sánchez, F; Cobo, J; Del Campo Albendea, L; Diaz Gago, Á; Escudero-Sánchez, R; Halperin, A; Moreno Guillén, S; Muriel, A; Ponce Alonso, M; Rubio Martín, E; Vizcarra, P, 2023)	0.91

Bioassays (158)

Assay ID	Title	Year	Journal	Article
AID543459	Drug level in clostridium difficile infected patient plasma at 200 mg/kg, po every 12 hrs for 10 days by RP-HPLC/MS	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1540921	Antibacterial activity against Clostridium difficile 4118 ATCC BAA 1870 assessed as bacterial growth inhibition incubated for 48 hrs under anaerobic condition by CLSI protocol-based assay
AID1063476	Antibacterial activity against Bacteroides fragilis ATCC 25285 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID543648	Antimicrobial activity against Clostridium difficile	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID543457	Antimicrobial activity against Clostridium difficile infected in patient assessed as percentage of patient require no further treatment at 400 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID543226	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 200 mg/kg, po BID measured on day 4 by the two-tailed Wilcoxon matched-pair, signed-rank t	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID523376	Antibacterial activity against Clostridium difficile ATCC 9689 in presence of 57 mg/L of magnesium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID533863	Antibacterial activity against toxin-positive Clostridium difficile clinical isolate by agar dilution method	2008	Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11	In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile.
AID518035	Selectivity ratio of MBC to MIC for coagulase-negative Staphylococcus	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID523372	Antibacterial activity against Clostridium difficile ATCC 700057 in presence of 30 mg/L of magnesium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID1063475	Antibacterial activity against Bacteroides thetaiotaomicron ATCC 29148 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID1705543	Antibacterial activity against Clostridium difficile ATCC 9689 assessed as reduction in bacterial toxin B production at sub-inhibitory concentration incubated for 48 hrs under anaerobic condition by ELISA	2020	European journal of medicinal chemistry, Dec-15, Volume: 208	Benzyl and benzoyl benzoic acid inhibitors of bacterial RNA polymerase-sigma factor interaction.
AID518009	Antibacterial activity against methicillin-resistant coagulase-negative Staphylococcus by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID543441	Antimicrobial activity against Clostridium difficile infected in patient assessed as recurrence of diarrhea within 6 weeks after treatment at 200 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID518008	Antibacterial activity against methicillin-susceptible coagulase-negative Staphylococcus by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID1063477	Antibacterial activity against Clostridium perfringens ATCC 13124 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID543464	Drug level in clostridium difficile infected patient feces at 100 mg/kg, po every 12 hrs for 10 days by RP-HPLC/MS	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID518034	Selectivity ratio of MBC to MIC for Staphylococcus aureus	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID523367	Antibacterial activity against Clostridium difficile ATCC 700057 in presence of 75 mg/L of calcium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID341089	Antimicrobial activity against Clostridium difficile clinical isolates by agar dilution method	2007	Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8	In vitro activities of 15 antimicrobial agents against 110 toxigenic clostridium difficile clinical isolates collected from 1983 to 2004.
AID543218	Antimicrobial activity against Bacteroides group obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 200 mg/kg, po BID measured on day 10 by the two-tailed Wilcoxon matched-pair, signed-rank test	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1540930	Effect on growth of Bifidobacterium bifidum 212A ATCC 11863 measured after 48 hrs in anerobic conditions by CLSI method
AID1063466	Antibacterial activity against stationary phase of Clostridium difficile CD196 assessed as cell killing at 1 to 20 X MIC after 3 to 6 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID543443	Antimicrobial activity against Clostridium difficile infected in patient assessed as resolving of diarrhea after 10 days at 400 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1063479	Antibacterial activity against Clostridium difficile clinical isolate assessed as growth inhibition	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID543213	Antimicrobial activity against Clostridium difficile	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1063471	Antibacterial activity against Staphylococcus aureus 8325-4 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID543454	Antimicrobial activity against Clostridium difficile infected in patient assessed as complete relief of clostridium difficile associated diarrhea symptom in patient at 400 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1760139	Antibacterial activity against gut Veillonella sp HM-49 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID1676976	Antimicrobial activity against Clostridioides difficile NR-32895 P19 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID1867111	Antibacterial activity against Bacteroides fragilis ATCC 25285 assessed as inhibition of bacterial growth by CLSI based agar dilution susceptibility analysis
AID543460	Drug level in clostridium difficile infected patient plasma at 400 mg/kg, po every 12 hrs for 10 days by RP-HPLC/MS	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID543453	Antimicrobial activity against Clostridium difficile infected in patient assessed as percentage of patient require no further treatment at 200 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1676975	Antimicrobial activity against Clostridioides difficile NR-32891 P13 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID523382	Ratio of MIC for Clostridium difficile ATCC 700057 at pH 6 to MIC for Clostridium difficile ATCC 700057 at pH 8.1 by broth microdilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID543225	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 100 mg/kg, po BID measured on day 4 by the two-tailed Wilcoxon matched-pair, signed-rank t	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1540944	Drug level in CDI patient plasma at 200 mg, po administered every 12 hrs for 10 days and measured 3 to 5 hrs post last dose by LC-MS/MS analysis
AID523366	Antibacterial activity against Clostridium difficile ATCC 700057 in presence of 45 mg/L of calcium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID518029	Selectivity ratio of MIC50 for methicillin-susceptible Staphylococcus aureus to MIC50 for methicillin-resistant Staphylococcus aureus	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID543466	Drug level in clostridium difficile infected patient feces at 400 mg/kg, po every 12 hrs for 10 days by RP-HPLC/MS	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1676995	Antibacterial activity against Lactobacillus crispatus HM-103 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID543217	Antimicrobial activity against Bacteroides group obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 100 mg/kg, po BID measured on day 10 by the two-tailed Wilcoxon matched-pair, signed-rank test	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID543220	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 50 mg/kg, po BID measured on day 10 by the two-tailed Wilcoxon matched-pair, signed-rank t	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID543451	Antimicrobial activity against Clostridium difficile infected in patient assessed as incomplete relief of clostridium difficile associated diarrhea symptom in patient at 200 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1676998	Antibacterial activity against Bacteroides fragilis HM-709 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID1705542	Antibacterial activity against Clostridium difficile ATCC 9689 assessed as reduction in bacterial toxin A production at sub-inhibitory concentration incubated for 48 hrs under anaerobic condition by ELISA	2020	European journal of medicinal chemistry, Dec-15, Volume: 208	Benzyl and benzoyl benzoic acid inhibitors of bacterial RNA polymerase-sigma factor interaction.
AID523370	Antibacterial activity against Clostridium difficile ATCC 9689 in presence of 75 mg/L of calcium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID518039	Antibacterial activity against Enterococcus by agar dilution technique	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID543458	Drug level in clostridium difficile infected patient plasma at 100 mg/kg, po every 12 hrs for 10 days by RP-HPLC/MS	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1354468	Antimicrobial activity against Bacillus thuringiensis SCSIO BT01 by broth microdilution method	2018	Journal of natural products, 05-25, Volume: 81, Issue:5	Tiacumicin Congeners with Improved Antibacterial Activity from a Halogenase-Inactivated Mutant.
AID543227	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 200 mg/kg, po BID measured on day 8 by the two-tailed Wilcoxon matched-pair, signed-rank t	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1760134	Antibacterial activity against gut Bifidobacterium longum HM-846 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID543409	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as reduction in bacterial cytotoxin B in patients at 100 mg/kg, po BID measured at 21 to 28 days by the two-tailed Wilcoxon matched-pa	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID518006	Antibacterial activity against methicillin-susceptible Staphylococcus aureus by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID543450	Antimicrobial activity against Clostridium difficile infected in patient assessed as complete relief of clostridium difficile associated diarrhea symptom in patient at 200 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1676996	Antibacterial activity against Lactobacillus crispatus HM-371 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID523365	Antibacterial activity against Clostridium difficile ATCC 700057 in presence of 33 mg/L of calcium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID543216	Antimicrobial activity against Bacteroides group obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 50 mg/kg, po BID measured on day 10 by the two-tailed Wilcoxon matched-pair, signed-rank test	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID523371	Antibacterial activity against Clostridium difficile ATCC 700057 in presence of 21 mg/L of magnesium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID1760130	Antibacterial activity against Clostridium difficile ATCC 43255 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID518012	Antibacterial activity against vancomycin-susceptible Enterococcus faecium by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID518007	Antibacterial activity against methicillin-resistant Staphylococcus aureus by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID1540923	Bactericidal activity against Clostridium difficile 4118 ATCC BAA 1870 assessed as reduction in bacterial colony forming units at 8 fold MIC preincubated followed by re-plating on BHIS agar plate and measured after 24 hrs under anaerobic condition by time
AID1354466	Antimicrobial activity against methicillin-resistant Staphylococcus aureus isolate shhs-A1 by broth microdilution method	2018	Journal of natural products, 05-25, Volume: 81, Issue:5	Tiacumicin Congeners with Improved Antibacterial Activity from a Halogenase-Inactivated Mutant.
AID1676997	Antibacterial activity against Bacteroides fragilis HM-711 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID518038	Antibacterial activity against Staphylococcus by agar dilution technique	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID543229	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 100 mg/kg, po BID measured at 21 to 28 days by the two-tailed Wilcoxon matched-pair, signe	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1705546	Antibacterial activity against Clostridium difficile ribotype 027 assessed as reduction in bacterial toxin A production at sub-inhibitory concentration incubated for 48 hrs under anaerobic condition by ELISA	2020	European journal of medicinal chemistry, Dec-15, Volume: 208	Benzyl and benzoyl benzoic acid inhibitors of bacterial RNA polymerase-sigma factor interaction.
AID533873	Antibacterial activity against Clostridium difficile by M11-A5 CLSI agar dilution	2008	Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11	In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile.
AID518013	Antibacterial activity against vancomycin-resistant Enterococcus faecium by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID1354467	Antimicrobial activity against Micrococcus luteus SCSIO ML01 by broth microdilution method	2018	Journal of natural products, 05-25, Volume: 81, Issue:5	Tiacumicin Congeners with Improved Antibacterial Activity from a Halogenase-Inactivated Mutant.
AID518010	Antibacterial activity against vancomycin-susceptible Enterococcus faecalis by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID518033	Selectivity ratio of MIC90 for vancomycin-resistant Enterococcus faecium to MIC90 for vancomycin-resistant Enterococcus faecalis	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID543442	Antimicrobial activity against Clostridium difficile infected in patient assessed as resolution of diarrhea on day 10 at 400 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID533872	Antibacterial activity against Clostridium difficile by M11-A6 CLSI agar dilution	2008	Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11	In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile.
AID1540927	Effect on growth of Lactobacillus gasseri EX336960VC03 HM 400 measured after 48 hrs in anaerobic conditions by CLSI method
AID533867	Antibacterial activity against Clostridium difficile by broth microdilution method using Wilkins-Chalgren broth	2008	Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11	In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile.
AID1760136	Antibacterial activity against gut Fusobacterium nucleatum HM-992 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID543215	Antimicrobial activity against facultative gram-negative Bacteroides sp.	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID533868	Antibacterial activity against Clostridium difficile by agar dilution method using Wilkins-Chalgren agar	2008	Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11	In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile.
AID543440	Antimicrobial activity against Clostridium difficile infected in patient assessed as clinical failure at 200 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1760133	Antibacterial activity against gut Bacteroides fragilis HM-709 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID518011	Antibacterial activity against vancomycin-resistant Enterococcus faecalis by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID1705547	Antibacterial activity against Clostridium difficile ribotype 027 assessed as reduction in bacterial toxin B production at sub-inhibitory concentration incubated for 48 hrs under anaerobic condition by ELISA	2020	European journal of medicinal chemistry, Dec-15, Volume: 208	Benzyl and benzoyl benzoic acid inhibitors of bacterial RNA polymerase-sigma factor interaction.
AID523378	Ratio of MIC for Clostridium difficile ATCC 9689 at pH 6.2 to MIC for Clostridium difficile ATCC 9689 at pH 7.9 by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID543214	Antimicrobial activity against aerobic Bacteroides sp.	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID533871	Antibacterial activity against Clostridium difficile by M11-A7 CLSI agar dilution	2008	Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11	In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile.
AID1063478	Antibacterial activity against Clostridium difficile CD196 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID1063469	Antibacterial activity against Escherichia coli ATCC 700927 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID1063470	Antibacterial activity against Streptococcus mutans ATCC 700610 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID1760135	Antibacterial activity against gut Corynebacterium HM-784 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID1676994	Antibacterial activity against Lactobacillus gasseri HM-400 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID543452	Antimicrobial activity against Clostridium difficile infected in patient assessed as percentage of patient require further treatment at 200 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1063468	Antibacterial activity against Enterococcus faecalis ATCC 47077 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID543447	Antimicrobial activity against Clostridium difficile infected in patient assessed as incomplete relief of clostridium difficile associated diarrhea symptom in patient at 100 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1867110	Antibacterial activity against Clostridioides difficile assessed as inhibition of bacterial growth by CLSI based agar dilution susceptibility analysis
AID543455	Antimicrobial activity against Clostridium difficile infected in patient assessed as incomplete relief of clostridium difficile associated diarrhea symptom in patient at 400 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID543446	Antimicrobial activity against Clostridium difficile infected in patient assessed as complete relief of clostridium difficile associated diarrhea symptom in patient at 100 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1063474	Antibacterial activity against Bifidobacterium longum ATCC BAA-999 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID523369	Antibacterial activity against Clostridium difficile ATCC 9689 in presence of 45 mg/L of calcium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID533869	Cmax in syrian golden hamster serum at 200 mg administered BID after 1.5 hrs	2008	Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11	In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile.
AID543437	Antimicrobial activity against Clostridium difficile infected in patient assessed as recurrence of diarrhea within 6 weeks after treatment at 100 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID523379	Ratio of MIC for Clostridium difficile ATCC 700057 at pH 7 to MIC for Clostridium difficile ATCC 700057 at pH 7.9 by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID1676977	Antimicrobial activity against Clostridioides difficile NR-32904 P30 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID1760138	Antibacterial activity against gut Lactobacillus gasseri HM-664 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID1705544	Antibacterial activity against Clostridium difficile ribotype 002 assessed as reduction in bacterial toxin A production at sub-inhibitory concentration incubated for 48 hrs under anaerobic condition by ELISA	2020	European journal of medicinal chemistry, Dec-15, Volume: 208	Benzyl and benzoyl benzoic acid inhibitors of bacterial RNA polymerase-sigma factor interaction.
AID543408	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as reduction in bacterial cytotoxin B in patients at 200 mg/kg, po BID measured at 21 to 28 days by the two-tailed Wilcoxon matched-pa	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID543438	Antimicrobial activity against Clostridium difficile infected in patient assessed as resolution of diarrhea on day 10 at 200 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID523373	Antibacterial activity against Clostridium difficile ATCC 700057 in presence of 57 mg/L of magnesium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID1705545	Antibacterial activity against Clostridium difficile ribotype 002 assessed as reduction in bacterial toxin B production at sub-inhibitory concentration incubated for 48 hrs under anaerobic condition by ELISA	2020	European journal of medicinal chemistry, Dec-15, Volume: 208	Benzyl and benzoyl benzoic acid inhibitors of bacterial RNA polymerase-sigma factor interaction.
AID1676972	Antimicrobial activity against Clostridioides difficile NR-13432 isolate 6 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID523375	Antibacterial activity against Clostridium difficile ATCC 9689 in presence of 30 mg/L of magnesium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID1354469	Antimicrobial activity against Enterococcus faecalis ATCC 29212 by broth microdilution method	2018	Journal of natural products, 05-25, Volume: 81, Issue:5	Tiacumicin Congeners with Improved Antibacterial Activity from a Halogenase-Inactivated Mutant.
AID543444	Antimicrobial activity against Clostridium difficile infected in patient assessed as clinical failure at 400 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID523374	Antibacterial activity against Clostridium difficile ATCC 9689 in presence of 21 mg/L of magnesium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID543445	Antimicrobial activity against Clostridium difficile infected in patient assessed as recurrence of diarrhea within 6 weeks after treatment at 400 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID543230	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 200 mg/kg, po BID measured at 21 to 28 days by the two-tailed Wilcoxon matched-pair, signe	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1540931	Effect on growth of Escherichia coli ATCC 25922 assessed as bacterial growth inhibition measured after 16 to 18 hrs by CLSI method
AID543434	Antimicrobial activity against Clostridium difficile infected in patient assessed as resolution of diarrhea on day 10 at 100 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID518036	Selectivity ratio of MBC to MIC for Enterococcus faecalis	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID543456	Antimicrobial activity against Clostridium difficile infected in patient assessed as percentage of patient require further treatment at 400 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID523381	Ratio of MIC for Clostridium difficile ATCC 700057 at pH 6 to MIC for Clostridium difficile ATCC 700057 at pH 7.5 by broth microdilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID543222	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 200 mg/kg, po BID measured on day 10 by the two-tailed Wilcoxon matched-pair, signed-rank	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1760137	Antibacterial activity against gut Limosilactobacillus-reuteri HM-102 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID523364	Antibacterial activity against Clostridium difficile ATCC 700057 by CLSI agar dilution method using 10'5 to 10'8 CFU/ml inoculum	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID1540932	Effect on growth of Enterobacter cloacae ATCC BAA 1143 assessed as bacterial growth inhibition measured after 16 to 18 hrs grown in tryptic soy medium by CLSI method
AID1676999	Antibacterial activity against Bacteroides dorei HM-719 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID543435	Antimicrobial activity against Clostridium difficile infected in patient assessed as resolving of diarrhea after 10 days at 100 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID543436	Antimicrobial activity against Clostridium difficile infected in patient assessed as clinical failure at 100 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID518031	Selectivity ratio of MIC50 for vancomycin-susceptible Enterococcus faecium to MIC50 for vancomycin-susceptible Enterococcus faecalis	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID523377	Ratio of MIC for Clostridium difficile ATCC 700057 at pH 6.2 to MIC for Clostridium difficile ATCC 700057 at pH 7.9 by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID518032	Selectivity ratio of MIC50 for vancomycin-resistant Enterococcus faecium to MIC50 for vancomycin-resistant Enterococcus faecalis	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID543221	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 100 mg/kg, po BID measured on day 10 by the two-tailed Wilcoxon matched-pair, signed-rank	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1354465	Antimicrobial activity against Staphylococcus aureus ATCC 29213 by broth microdilution method	2018	Journal of natural products, 05-25, Volume: 81, Issue:5	Tiacumicin Congeners with Improved Antibacterial Activity from a Halogenase-Inactivated Mutant.
AID523368	Antibacterial activity against Clostridium difficile ATCC 9689 in presence of 33 mg/L of calcium ion by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID1676971	Antimicrobial activity against Clostridioides difficile ATCC BAA 1801 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID543465	Drug level in clostridium difficile infected patient feces at 200 mg/kg, po every 12 hrs for 10 days by RP-HPLC/MS	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID543228	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 50 mg/kg, po BID measured at 21 to 28 days by the two-tailed Wilcoxon matched-pair, signed	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1676973	Antimicrobial activity against Clostridioides difficile NR-13435 isolate 9 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID1760140	Antibacterial activity against gut Eubacterium sp. HM-178 assessed as reduction in bacterial growth measured after 48 hrs by CLSI based broth microdilution method	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Structure-Activity Relationship for the Picolinamide Antibacterials that Selectively Target
AID543410	Antimicrobial activity against Clostridium difficile obtained from patient with Clostridium difficile infection assessed as bacterial count per gram of wet stool at 50 mg/kg, po BID measured on day 4 by the two-tailed Wilcoxon matched-pair, signed-rank te	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	OPT-80 eliminates Clostridium difficile and is sparing of bacteroides species during treatment of C. difficile infection.
AID1063473	Antibacterial activity against Lactobacillus casei ATCC 334 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID1540929	Effect on growth of Lactobacillus crispatus JV-V01 HM 103 measured after 48 hrs in anaerobic conditions by CLSI method
AID1540928	Effect on growth of Lactobacillus casei ATCC 334 measured after 48 hrs in anaerobic conditions by CLSI method
AID523380	Ratio of MIC for Clostridium difficile ATCC 9689 at pH 7 to MIC for Clostridium difficile ATCC 9689 at pH 7.9 by CLSI agar dilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID543439	Antimicrobial activity against Clostridium difficile infected in patient assessed as resolving of diarrhea after 10 days at 200 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID543448	Antimicrobial activity against Clostridium difficile infected in patient assessed as percentage of patient require further treatment at 100 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID1676974	Antimicrobial activity against Clostridioides difficile NR-32883 P2 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID1676978	Antimicrobial activity against Clostridioides difficile ATCC 43255 assessed as reduction in microbial growth after 48 hrs by broth microdilution method
AID543449	Antimicrobial activity against Clostridium difficile infected in patient assessed as percentage of patient require no further treatment at 100 mg/kg, po every 12 hrs for 10 days	2009	Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1	Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection.
AID523384	Ratio of MIC for Clostridium difficile ATCC 9689 at pH 6 to MIC for Clostridium difficile ATCC 9689 at pH 8.1 by broth microdilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID1063472	Antibacterial activity against Lactobacillus reuteri ATCC 23272 assessed as growth inhibition after 20 to 24 hrs	2014	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 24, Issue:2	Diarylacylhydrazones: Clostridium-selective antibacterials with activity against stationary-phase cells.
AID1540922	Antibacterial activity against Clostridium difficile VPI 10463 ATCC 43255 assessed as bacterial growth inhibition incubated for 48 hrs under anaerobic condition by CLSI protocol based assay
AID523363	Antibacterial activity against Clostridium difficile ATCC 9689 by CLSI agar dilution method using 10'5 to 10'8 CFU/ml inoculum	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID533870	Apparent elimination half-life in syrian golden hamster at 400 mg/kg	2008	Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11	In vitro activity of OPT-80 tested against clinical isolates of toxin-producing Clostridium difficile.
AID523383	Ratio of MIC for Clostridium difficile ATCC 9689 at pH 6 to MIC for Clostridium difficile ATCC 9689 at pH 7.5 by broth microdilution method	2010	Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6	Effects of inoculum, pH, and cations on the in vitro activity of fidaxomicin (OPT-80, PAR-101) against Clostridium difficile.
AID518037	Selectivity ratio of MBC to MIC for Enterococcus faecium	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
AID518030	Antibacterial activity against linezolid-nonsusceptible Staphylococcus aureus by broth microdilution method	2010	Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5	In vitro activity of fidaxomicin (OPT-80) tested against contemporary clinical isolates of Staphylococcus spp. and Enterococcus spp.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	7 (2.06)	18.7374
1990's	2 (0.59)	18.2507
2000's	10 (2.95)	29.6817
2010's	237 (69.91)	24.3611
2020's	83 (24.48)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	35 (10.09%)	5.53%
Reviews	85 (24.50%)	6.00%
Case Studies	17 (4.90%)	4.05%
Observational	5 (1.44%)	0.25%
Other	205 (59.08%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (26)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea [NCT00314951]	Phase 3	629 participants (Actual)	Interventional	2006-05-02	Completed
Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection [NCT02464306]	Phase 4	0 participants (Actual)	Interventional	2018-06-30	Withdrawn(stopped due to Lost funding)
OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD) [NCT02179658]	Phase 3	210 participants (Actual)	Interventional	2014-06-23	Completed
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE Study) [NCT02214771]		296 participants (Actual)	Observational	2014-09-03	Completed
Prospective, Open-label Trial to Evaluate Efficacy of 30-day Duration of Fidaxomicin in Patients With Recurrent C. Difficile Infection [NCT02395848]	Phase 3	31 participants (Actual)	Interventional	2015-07-31	Terminated(stopped due to Insufficient resource to complete the study)
Role of Fidaxomicin in a Patient Population With Problematic Clostridium Difficile Infection [NCT02355938]	Phase 4	12 participants (Actual)	Interventional	2014-02-28	Terminated(stopped due to Lost funding due to low enrollment.)
A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI) [NCT02784002]	Phase 2	27 participants (Actual)	Interventional	2014-12-31	Completed
A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population [NCT02254967]	Phase 4	364 participants (Actual)	Interventional	2014-11-06	Completed
A Phase 1, Open Label, Randomized, Two-way Crossover Study to Evaluate the Effect of Multiple Doses of Fidaxomicin on the Single Dose Pharmacokinetics of Rosuvastatin in Healthy Male Subjects [NCT02083627]	Phase 1	25 participants (Actual)	Interventional	2013-02-28	Completed
Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection [NCT02743234]	Phase 3	64 participants (Actual)	Interventional	2016-04-30	Completed
A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin. [NCT05201079]	Phase 3	66 participants (Anticipated)	Interventional	2021-10-29	Recruiting
Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI) [NCT04070352]		50 participants (Anticipated)	Observational	2019-08-01	Enrolling by invitation
CSP #596 - Optimal Treatment for Recurrent Clostridium Difficile Infection [NCT02667418]	Phase 4	549 participants (Anticipated)	Interventional	2015-12-21	Recruiting
The Effect of a Twice Daily, 200 mg Dose of Oral Fidaxomicin Compared to Placebo on Risk of Acquiring C. Difficile and Developing C. Difficile Infection (CDI) in High Risk Patients [NCT01552668]	Phase 4	0 participants (Actual)	Interventional	2012-09-30	Withdrawn(stopped due to Study not performed)
A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections [NCT02692651]	Phase 4	144 participants (Actual)	Interventional	2017-05-01	Completed
A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy [NCT01775397]	Phase 4	12 participants (Actual)	Interventional	2012-11-29	Terminated(stopped due to Study terminated due to difficulty in enrollment)
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects [NCT01813448]	Phase 1	36 participants (Actual)	Interventional	2013-02-28	Completed
Exploratory Study of Impact of Oral Metronidazole, Vancomycin and Fidaxomicin on the Extent and Quantity of Host Carriage and Environmental Contamination With C. Difficile [NCT02057198]	Phase 4	33 participants (Actual)	Interventional	2014-06-10	Completed
Fecal Microbiota Transplantation Versus Vancomycin or Fidaxomicin in Clostridioides Difficile Infection First Episode or First Recurrence: A Randomized Controlled, Open-label, Multicenter Phase III Clinical Trial [NCT05266807]	Phase 3	220 participants (Anticipated)	Interventional	2022-08-16	Recruiting
Two-arm, Interventional, Prospective, Open-label, Multi-center Trial to Evaluate the Safety & Effectiveness of FMT for Treatment of Adult Patients With Primary or Recurrent CDI, Using a Novel, Standardized Microbiota Transplantation System [NCT03053505]		150 participants (Anticipated)	Interventional	2017-01-31	Recruiting
Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI) [NCT02437591]	Phase 4	25 participants (Actual)	Interventional	2015-08-13	Completed
A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) [NCT01591863]	Phase 2	38 participants (Actual)	Interventional	2012-06-15	Completed
Serial Fecal Microbiota Transplant (FMT) Plus Fidaxomicin in the Treatment of Severe or Fulminant Clostridium Difficile Infection, With Detailed Characterization in Microbiota, Metabolomics and Host Immune Response [NCT03760484]	Phase 2	4 participants (Actual)	Interventional	2019-01-21	Terminated(stopped due to Difficulty enrolling participants/COVID pandemic/lack of continued in-kind support from product manufacturer.)
A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects W [NCT02218372]	Phase 3	148 participants (Actual)	Interventional	2015-01-09	Completed
An Open-label, Randomized Study to Assess Inhibition of Spore Production in Patients With Clostridium Difficile Infections: Fidaxomicin Versus Vancomycin [NCT01818141]	Phase 4	34 participants (Actual)	Interventional	2012-10-17	Completed
DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Tra [NCT01691248]	Phase 3	611 participants (Actual)	Interventional	2012-10-10	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00314951 (3) [back to overview]	Cure Rate at End of Therapy
NCT00314951 (3) [back to overview]	Global Cure
NCT00314951 (3) [back to overview]	Recurrence
NCT01591863 (7) [back to overview]	Number of Participants With Adverse Events.
NCT01591863 (7) [back to overview]	Evaluate the Clinical Outcome by Assessment of Clinical Response.
NCT01591863 (7) [back to overview]	Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.
NCT01591863 (7) [back to overview]	Investigate Concentrations of Fidaxomicin in Fecal Samples.
NCT01591863 (7) [back to overview]	Investigate Concentrations of Fidaxomicin in Plasma Samples.
NCT01591863 (7) [back to overview]	Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.
NCT01591863 (7) [back to overview]	Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.
NCT01691248 (3) [back to overview]	Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.
NCT01691248 (3) [back to overview]	Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.
NCT01691248 (3) [back to overview]	Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.
NCT01818141 (2) [back to overview]	C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
NCT01818141 (2) [back to overview]	C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
NCT02057198 (6) [back to overview]	Percentage of Stool Specimens From Patients That Are Positive for C. Difficile
NCT02057198 (6) [back to overview]	Molecular Relatedness of Isolates
NCT02057198 (6) [back to overview]	Total Environmental Contamination According to Antibiotic Treatment Group
NCT02057198 (6) [back to overview]	C. Difficile Shedding in Stool Over Time
NCT02057198 (6) [back to overview]	Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.
NCT02057198 (6) [back to overview]	Count of Stool Specimens From Patients That Are Positive for C. Difficile
NCT02218372 (23) [back to overview]	Time to Resolution of Diarrhea (TTROD)
NCT02218372 (23) [back to overview]	Acceptance of Formulation (Palatability Assessment) in All Participants at First Administration of Study Drug and at Day 7
NCT02218372 (23) [back to overview]	Metabolite-to-Parent Ratio (MPRconc)
NCT02218372 (23) [back to overview]	Percentage of Participants With SCR at EOT +16 Days
NCT02218372 (23) [back to overview]	Plasma Concentrations of Fidaxomicin
NCT02218372 (23) [back to overview]	Plasma Concentrations of Metabolite OP-1118
NCT02218372 (23) [back to overview]	Number of Participants With Adverse Events (AEs)
NCT02218372 (23) [back to overview]	Percentage of Participants With GC at EOT +23 Days
NCT02218372 (23) [back to overview]	Fecal Concentrations of Fidaxomicin
NCT02218372 (23) [back to overview]	Fecal Concentrations of Metabolite OP-1118
NCT02218372 (23) [back to overview]	MPRconc Within 24 Hours of a Dose
NCT02218372 (23) [back to overview]	Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days
NCT02218372 (23) [back to overview]	Percentage of Participants With GC at EOS (EOT +30 Days)
NCT02218372 (23) [back to overview]	Percentage of Participants With GC at EOT +16 Days
NCT02218372 (23) [back to overview]	Percentage of Participants With Global Cure (GC) at EOT +9 Days
NCT02218372 (23) [back to overview]	Percentage of Participants With Recurrence of CDAD at EOS (EOT +30 Days)
NCT02218372 (23) [back to overview]	Percentage of Participants With Recurrence of CDAD at EOT +16 Days
NCT02218372 (23) [back to overview]	Percentage of Participants With Recurrence of CDAD at EOT +23 Days
NCT02218372 (23) [back to overview]	Percentage of Participants With Recurrence of CDAD at EOT +9 Days
NCT02218372 (23) [back to overview]	Percentage of Participants With SCR at End of Study (EOS) (EOT +30 Days)
NCT02218372 (23) [back to overview]	Percentage of Participants With SCR at EOT +23 Days
NCT02218372 (23) [back to overview]	Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days
NCT02218372 (23) [back to overview]	Time to Recurrence of CDAD for Participants With CCR at EOT +2 Days
NCT02395848 (3) [back to overview]	Clinical Response at 30-day Completion of Fidaxomicin
NCT02395848 (3) [back to overview]	Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin
NCT02395848 (3) [back to overview]	Treatment Failure
NCT02692651 (3) [back to overview]	30-day Mortality
NCT02692651 (3) [back to overview]	Recurrence of CDI
NCT02692651 (3) [back to overview]	Clinical Cure: Resolution of Diarrhea
NCT03760484 (7) [back to overview]	C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))
NCT03760484 (7) [back to overview]	Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))
NCT03760484 (7) [back to overview]	Infection
NCT03760484 (7) [back to overview]	Hospitalization
NCT03760484 (7) [back to overview]	Death
NCT03760484 (7) [back to overview]	Colectomy
NCT03760484 (7) [back to overview]	Perforation

Cure Rate at End of Therapy

Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication. (NCT00314951)
Timeframe: Study day 10 (+/- 2 days)

Intervention	Percentage of Participants (Number)
Vancomycin	85.7
Fidaxomicin	88.2

Intervention	% of positive stool cultures (Number)
	Day 0	Day 3	Day 7	Day 14
Fidaxomicin	100	60	0	0
Metronidazole	95.5	75	0	0
Vancomycin	85	33	0	0

Intervention	Participants (Count of Participants)
	Day 1 Awful	Day 1 Poor	Day 1 Fair	Day 1 Good	Day 1 Excellent	Day 1 Missing	Day 7 Awful	Day 7 Poor	Day 7 Fair	Day 7 Good	Day 7 Excellent	Day 7 Missing
Fidaxomicin Oral Suspension	4	6	13	19	13	12	2	5	8	21	16	15
Vancomycin Oral Liquid	5	3	6	7	4	5	3	5	5	9	3	5

Intervention	ratio (Mean)
	Predose	Postdose
Fidaxomicin Oral Suspension	3.24	2.95
Fidaxomicin Tablets	3.05	2.69
Fidaxomin All Formulations	3.18	2.86

Intervention	Participants (Count of Participants)
	TEAE	Drug-related TEAE	Serious TEAE	Drug-related Serious TEAE	Moderate TEAE	Drug-related Moderate TEAE	Mild TEAE	Drug-related Mild TEAE	TEAE Leading to Death	Drug-related TEAE Leading to Death	TEAE leading to Withdrawal of Treatment (Tx)	Drug-related TEAE Leading to Withdrawal of Tx
Fidaxomicin	72	7	24	0	39	4	56	3	3	0	1	0
Vancomycin	33	5	12	0	14	1	30	4	0	0	1	0

Intervention	μg/g (Mean)
Fidaxomin All Formulations	2685.56
Fidaxomicin Oral Suspension	2969.87
Fidaxomicin Tablets	2190.63

Intervention	μg/g (Mean)
Fidaxomin All Formulations	889.23
Fidaxomicin Oral Suspension	789.15
Fidaxomicin Tablets	1059.73

Intervention	ratio (Mean)
Fidaxomin All Formulations	0.43
Fidaxomicin Oral Suspension	0.32
Fidaxomicin Tablets	0.63

Condition	Indicated	Relationship Strength	Studies	Trials
Antibiotic-Associated Colitis [description not available]	0	17.97	97	30
Enterocolitis, Pseudomembranous An acute inflammation of the INTESTINAL MUCOSA that is characterized by the presence of pseudomembranes or plaques in the SMALL INTESTINE (pseudomembranous enteritis) and the LARGE INTESTINE (pseudomembranous colitis). It is commonly associated with antibiotic therapy and CLOSTRIDIUM DIFFICILE colonization.	0	17.97	97	30
Health Care Associated Infection [description not available]	0	8.37	17	2
Cross Infection Any infection which a patient contracts in a health-care institution.	0	8.37	17	2
Clostridioides difficile Infection [description not available]	0	21.1	235	58
Clostridium Infections Infections with bacteria of the genus CLOSTRIDIUM and closely related CLOSTRIDIOIDES species.	1	25.86	470	116
Recrudescence [description not available]	0	17.36	85	23
2019 Novel Coronavirus Disease [description not available]	0	5.34	3	1
Diarrhea An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.	1	18.45	61	22
Atypical Mycobacterial Infection, Disseminated [description not available]	0	2.41	1	0
Dermatitis Medicamentosa [description not available]	0	2.6	1	0
Exanthem [description not available]	0	2.6	1	0
Allergic Reaction [description not available]	0	3.01	2	0
Exanthema Diseases in which skin eruptions or rashes are a prominent manifestation. Classically, six such diseases were described with similar rashes; they were numbered in the order in which they were reported. Only the fourth (Duke's disease), fifth (ERYTHEMA INFECTIOSUM), and sixth (EXANTHEMA SUBITUM) numeric designations survive as occasional synonyms in current terminology.	0	2.6	1	0
Hypersensitivity Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.	0	8.01	2	0
Diabetes Mellitus, Adult-Onset [description not available]	0	2.6	1	0
Diabetes Mellitus, Type 2 A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.	0	2.6	1	0
Colitis Inflammation of the COLON section of the large intestine (INTESTINE, LARGE), usually with symptoms such as DIARRHEA (often with blood and mucus), ABDOMINAL PAIN, and FEVER.	0	2.72	2	0
Bowel Diseases, Inflammatory [description not available]	0	6.65	6	1
Inflammatory Bowel Diseases Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.	0	6.65	6	1
Local Neoplasm Recurrence [description not available]	0	3.52	1	0
Canine Diseases [description not available]	0	2.6	1	0
Cat Diseases Diseases of the domestic cat (Felis catus or F. domesticus). This term does not include diseases of the so-called big cats such as CHEETAHS; LIONS; tigers, cougars, panthers, leopards, and other Felidae for which the heading CARNIVORA is used.	0	2.6	1	0
Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.	0	3.51	7	0
Osteomyelitis INFLAMMATION of the bone as a result of infection. It may be caused by a variety of infectious agents, especially pyogenic (PUS - producing) BACTERIA.	0	2.25	1	0
Infectious Diseases [description not available]	0	2.31	1	0
Communicable Diseases An illness caused by an infectious agent or its toxins that occurs through the direct or indirect transmission of the infectious agent or its products from an infected individual or via an animal, vector or the inanimate environment to a susceptible animal or human host.	0	2.31	1	0
Rheumatoid Arthritis [description not available]	0	2.25	1	0
Arthritis, Rheumatoid A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.	0	2.25	1	0
Cirrhosis, Liver [description not available]	0	2.25	1	0
Liver Cirrhosis Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.	0	2.25	1	0
Congenital Zika Syndrome [description not available]	0	2.25	1	0
Zika Virus Infection A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, in rare cases, is associated with congenital brain and ocular abnormalities, called Congenital Zika Syndrome, including MICROCEPHALY and may also lead to GUILLAIN-BARRE SYNDROME.	0	2.25	1	0
Infections, Coronavirus [description not available]	0	2.25	1	0
Pneumonia, Viral Inflammation of the lung parenchyma that is caused by a viral infection.	0	2.25	1	0
Coronavirus Infections Virus diseases caused by the CORONAVIRUS genus. Some specifics include transmissible enteritis of turkeys (ENTERITIS, TRANSMISSIBLE, OF TURKEYS); FELINE INFECTIOUS PERITONITIS; and transmissible gastroenteritis of swine (GASTROENTERITIS, TRANSMISSIBLE, OF SWINE).	0	2.25	1	0
Acinetobacter Infections Infections with bacteria of the genus ACINETOBACTER.	0	2.25	1	0
Tuberculosis, Drug-Resistant [description not available]	0	2.51	2	0
Koch's Disease [description not available]	0	2.31	1	0
Tuberculosis Any of the infectious diseases of man and other animals caused by species of MYCOBACTERIUM TUBERCULOSIS.	0	2.31	1	0
Tuberculosis, Multidrug-Resistant Tuberculosis resistant to chemotherapy with two or more ANTITUBERCULAR AGENTS, including at least ISONIAZID and RIFAMPICIN. The problem of resistance is particularly troublesome in tuberculous OPPORTUNISTIC INFECTIONS associated with HIV INFECTIONS. It requires the use of second line drugs which are more toxic than the first line regimens. TB with isolates that have developed further resistance to at least three of the six classes of second line drugs is defined as EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS.	0	2.51	2	0
Innate Inflammatory Response [description not available]	0	2.17	1	0
Inflammation A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.	0	2.17	1	0
Bacterial Disease [description not available]	0	3.93	4	0
Bacterial Infections Infections by bacteria, general or unspecified.	0	3.93	4	0
Graft-Versus-Host Disease [description not available]	0	2.17	1	0
Acute Disease Disease having a short and relatively severe course.	0	3.47	2	0
Graft vs Host Disease The clinical entity characterized by anorexia, diarrhea, loss of hair, leukopenia, thrombocytopenia, growth retardation, and eventual death brought about by the GRAFT VS HOST REACTION.	0	2.17	1	0
Kidney Failure A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism.	0	3.73	3	0
Liver Dysfunction [description not available]	0	2.17	1	0
Liver Diseases Pathological processes of the LIVER.	0	2.17	1	0
Renal Insufficiency Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE.	0	3.73	3	0
Adverse Drug Event [description not available]	0	7.27	4	2
Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.	0	7.27	4	2
Hematologic Malignancies [description not available]	0	2.21	1	0
Cancer of Colon [description not available]	0	2.21	1	0
Colonic Neoplasms Tumors or cancer of the COLON.	0	2.21	1	0
Hematologic Neoplasms Neoplasms located in the blood and blood-forming tissue (the bone marrow and lymphatic tissue). The commonest forms are the various types of LEUKEMIA, of LYMPHOMA, and of the progressive, life-threatening forms of the MYELODYSPLASTIC SYNDROMES.	0	2.21	1	0
Disease Exacerbation [description not available]	0	3.43	2	0
Chronic Kidney Diseases [description not available]	0	3.45	2	0
Chronic Kidney Failure [description not available]	0	3.12	1	0
Kidney Failure, Chronic The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.	0	3.12	1	0
Renal Insufficiency, Chronic Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)	0	3.45	2	0
Weight Reduction [description not available]	0	2.21	1	0
Obesity A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).	0	2.21	1	0
Weight Loss Decrease in existing BODY WEIGHT.	0	2.21	1	0
Cancer of Prostate [description not available]	0	3	1	0
Cancer of the Thyroid [description not available]	0	3	1	0
Prostatic Neoplasms Tumors or cancer of the PROSTATE.	0	3	1	0
Thyroid Neoplasms Tumors or cancer of the THYROID GLAND.	0	3	1	0
Pouch Ileitis [description not available]	0	2.1	1	0
Pouchitis Acute INFLAMMATION in the INTESTINAL MUCOSA of the continent ileal reservoir (or pouch) in patients who have undergone ILEOSTOMY and restorative proctocolectomy (PROCTOCOLECTOMY, RESTORATIVE).	0	2.1	1	0
Allergy, Drug [description not available]	0	2.52	2	0
Drug Hypersensitivity Immunologically mediated adverse reactions to medicinal substances used legally or illegally.	0	2.52	2	0
Carcinoma, Epidermoid [description not available]	0	2.08	1	0
Cancer of Mouth [description not available]	0	2.08	1	0
Endotoxin Shock [description not available]	0	2.52	2	0
Mandibular Neoplasms Tumors or cancer of the MANDIBLE.	0	2.08	1	0
Carcinoma, Squamous Cell A carcinoma derived from stratified SQUAMOUS EPITHELIAL CELLS. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)	0	2.08	1	0
Mouth Neoplasms Tumors or cancer of the MOUTH.	0	2.08	1	0
Necrosis The death of cells in an organ or tissue due to disease, injury or failure of the blood supply.	0	2.08	1	0
Shock, Septic Sepsis associated with HYPOTENSION or hypoperfusion despite adequate fluid resuscitation. Perfusion abnormalities may include but are not limited to LACTIC ACIDOSIS; OLIGURIA; or acute alteration in mental status.	0	2.52	2	0
Anasarca [description not available]	0	2.1	1	0
Edema Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.	0	2.1	1	0
Bacteremia The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.	0	2.5	2	0
Benign Neoplasms [description not available]	0	4.87	4	0
Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.	0	4.87	4	0
Co-infection [description not available]	0	2.1	1	0
Infections, Klebsiella [description not available]	0	2.1	1	0
Klebsiella Infections Infections with bacteria of the genus KLEBSIELLA.	0	2.1	1	0
Critical Illness A disease or state in which death is possible or imminent.	0	2.53	2	0
Cholera Infantum [description not available]	0	3.4	2	0
Colitis, Mucous [description not available]	0	2.49	2	0
Colicky Pain [description not available]	0	2.11	1	0
Abdominal Pain Sensation of discomfort, distress, or agony in the abdominal region.	0	2.11	1	0
Irritable Bowel Syndrome A disorder with chronic or recurrent colonic symptoms without a clearcut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION.	0	2.49	2	0
Duncan Disease [description not available]	0	2.1	1	0
Lymphoproliferative Disorders Disorders characterized by proliferation of lymphoid tissue, general or unspecified.	0	2.1	1	0
Community Acquired Infection [description not available]	0	2.53	2	0
Kidney Diseases Pathological processes of the KIDNEY or its component tissues.	0	2.11	1	0
Group A Strep Infection [description not available]	0	2.78	3	0
Streptococcal Infections Infections with bacteria of the genus STREPTOCOCCUS.	0	2.78	3	0
Disbacteriosis [description not available]	0	3.04	1	0
Campylobacter Infection [description not available]	0	3.04	1	0
Vibrio cholerae Infection [description not available]	0	3.04	1	0
Dysentery, Shiga bacillus [description not available]	0	3.04	1	0
E coli Infections [description not available]	0	3.04	1	0
Infections, Salmonella [description not available]	0	3.04	1	0
Infections, Yersinia [description not available]	0	3.04	1	0
Cholera An acute diarrheal disease endemic in India and Southeast Asia whose causative agent is VIBRIO CHOLERAE. This condition can lead to severe dehydration in a matter of hours unless quickly treated.	0	3.04	1	0
Dysentery, Bacillary DYSENTERY caused by gram-negative rod-shaped enteric bacteria (ENTEROBACTERIACEAE), most often by the genus SHIGELLA. Shigella dysentery, Shigellosis, is classified into subgroups according to syndrome severity and the infectious species. Group A: SHIGELLA DYSENTERIAE (severest); Group B: SHIGELLA FLEXNERI; Group C: SHIGELLA BOYDII; and Group D: SHIGELLA SONNEI (mildest).	0	3.04	1	0
Escherichia coli Infections Infections with bacteria of the species ESCHERICHIA COLI.	0	3.04	1	0
Gastroenteritis INFLAMMATION of any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM. Causes of gastroenteritis are many including genetic, infection, HYPERSENSITIVITY, drug effects, and CANCER.	0	3.04	1	0
Bacteroides Infections Infections with bacteria of the genus BACTEROIDES.	0	2.13	1	0
Megacolon, Toxic An acute form of MEGACOLON, severe pathological dilatation of the COLON. It is associated with clinical conditions such as ULCERATIVE COLITIS; CROHN DISEASE; AMEBIC DYSENTERY; or CLOSTRIDIUM ENTEROCOLITIS.	0	2.13	1	0
Acute Liver Injury, Drug-Induced [description not available]	0	2.15	1	0
Chemical and Drug Induced Liver Injury A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment.	0	2.15	1	0
Colitis, Granulomatous [description not available]	0	2.06	1	0
Encephalopathy, Hepatic [description not available]	0	2.06	1	0
Chronic Esophagitis, Eosinophilic [description not available]	0	2.06	1	0
Crohn Disease A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.	0	2.06	1	0
Hepatic Encephalopathy A syndrome characterized by central nervous system dysfunction in association with LIVER FAILURE, including portal-systemic shunts. Clinical features include lethargy and CONFUSION (frequently progressing to COMA); ASTERIXIS; NYSTAGMUS, PATHOLOGIC; brisk oculovestibular reflexes; decorticate and decerebrate posturing; MUSCLE SPASTICITY; and bilateral extensor plantar reflexes (see REFLEX, BABINSKI). ELECTROENCEPHALOGRAPHY may demonstrate triphasic waves. (From Adams et al., Principles of Neurology, 6th ed, pp1117-20; Plum & Posner, Diagnosis of Stupor and Coma, 3rd ed, p222-5)	0	2.06	1	0
Eosinophilic Esophagitis Chronic ESOPHAGITIS characterized by esophageal mucosal EOSINOPHILIA. It is diagnosed when an increase in EOSINOPHILS are present over the entire esophagus. The reflux symptoms fail to respond to PROTON PUMP INHIBITORS treatment, unlike in GASTROESOPHAGEAL REFLUX DISEASE. The symptoms are associated with IgE-mediated hypersensitivity to food or inhalant allergens.	0	2.06	1	0
Ileus A condition caused by the lack of intestinal PERISTALSIS or INTESTINAL MOTILITY without any mechanical obstruction. This interference of the flow of INTESTINAL CONTENTS often leads to INTESTINAL OBSTRUCTION. Ileus may be classified into postoperative, inflammatory, metabolic, neurogenic, and drug-induced.	0	2.98	1	0
Pyrexia [description not available]	0	2.07	1	0
Leukocytosis A transient increase in the number of leukocytes in a body fluid.	0	2.07	1	0
Fever An abnormal elevation of body temperature, usually as a result of a pathologic process.	0	2.07	1	0
Infections, Staphylococcal [description not available]	0	2.07	1	0
Staphylococcal Infections Infections with bacteria of the genus STAPHYLOCOCCUS.	0	2.07	1	0

fidaxomicin

Description

Cross-References

Synonyms (49)

Research Excerpts

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Bioassays (158)

Research

Studies (339)

Study Types

Clinical Trials (26)

Trial Overview

Trial Outcomes

Cure Rate at End of Therapy

Global Cure

Recurrence

Number of Participants With Adverse Events.

Evaluate the Clinical Outcome by Assessment of Clinical Response.

Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.

Investigate Concentrations of Fidaxomicin in Fecal Samples.

Investigate Concentrations of Fidaxomicin in Plasma Samples.

Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.

Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.

Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.

Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.

Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.

C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool

C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool

Percentage of Stool Specimens From Patients That Are Positive for C. Difficile

Molecular Relatedness of Isolates

Total Environmental Contamination According to Antibiotic Treatment Group

C. Difficile Shedding in Stool Over Time

Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.

Count of Stool Specimens From Patients That Are Positive for C. Difficile

Time to Resolution of Diarrhea (TTROD)

Acceptance of Formulation (Palatability Assessment) in All Participants at First Administration of Study Drug and at Day 7

Metabolite-to-Parent Ratio (MPRconc)

Percentage of Participants With SCR at EOT +16 Days

Plasma Concentrations of Fidaxomicin

Plasma Concentrations of Metabolite OP-1118

Number of Participants With Adverse Events (AEs)

Percentage of Participants With GC at EOT +23 Days

Fecal Concentrations of Fidaxomicin

Fecal Concentrations of Metabolite OP-1118

MPRconc Within 24 Hours of a Dose

Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days

Percentage of Participants With GC at EOS (EOT +30 Days)

Percentage of Participants With GC at EOT +16 Days

Percentage of Participants With Global Cure (GC) at EOT +9 Days

Percentage of Participants With Recurrence of CDAD at EOS (EOT +30 Days)

Percentage of Participants With Recurrence of CDAD at EOT +16 Days

Percentage of Participants With Recurrence of CDAD at EOT +23 Days

Percentage of Participants With Recurrence of CDAD at EOT +9 Days

Percentage of Participants With SCR at End of Study (EOS) (EOT +30 Days)

Percentage of Participants With SCR at EOT +23 Days

Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days

Time to Recurrence of CDAD for Participants With CCR at EOT +2 Days

Clinical Response at 30-day Completion of Fidaxomicin

Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin

Treatment Failure

30-day Mortality

Recurrence of CDI

Clinical Cure: Resolution of Diarrhea

C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))

Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))

Infection

Hospitalization

Death

Colectomy

Perforation

Related Drugs (93)

Related Conditions (129)