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fanasil, pyrimethamine drug combination

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

fanasil, pyrimethamine drug combination: combination drug containing fanasil & pyrimethamine [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID65404
CHEMBL ID3137690
SCHEMBL ID125901
MeSH IDM0041309

Synonyms (28)

Synonym
nsc618943
nsc-618943
fansidar (tn)
D02448
pyrimethamine - sulfadoxine mixt
benzenesulfonamide, 4-amino-n-(5,6-dimethoxy-4-pyrimidinyl)-, mixt. with 5-(4-chlorophenyl)-6-ethyl-2,4-pyrimidinediamine
suldox
pyrimethamine combination with sulfadoxine
pyrimethamine-sulfadoxine
4-amino-n-(5,6-dimethoxypyrimidin-4-yl)benzenesulfonamide; 5-(4-chlorophenyl)-6-ethyl-pyrimidine-2,4-diamine
37338-39-9
pyrimethamine & sulfadoxine
fansidar
fanasil, pyrimethamine drug combination
sulfadoxine-pyrimethamine
sulphadoxine-pyrimethamine
fanasil - pyrimethamine
pyrimethamine-sulfadoxine mixt.
sulfadoxine-pyrimethamine mixt.
sulphadoxine / pyrimethamine
sulfadoxine / pyrimethamine
sulphadoxyne-pyrimethamine
pyrimethamine / sulfadoxine
sulfadoxine and pyrimethamine
CHEMBL3137690
SCHEMBL125901
DTXSID70190780
4-amino-n-(5,6-dimethoxypyrimidin-4-yl)benzenesulfonamide;5-(4-chlorophenyl)-6-ethylpyrimidine-2,4-diamine

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Safe and effective drugs, capable of being administered as a single-dose or short-course treatment, are urgently needed to control the adaptable malaria parasite."( Falciparum malaria: the urgent need for safe and effective drugs.
Rieckmann, KH, 1983
)
0.27
" Differences in rates of adverse outcomes between the three groups were not statistically significant."( Safety of mefloquine and other antimalarial agents in the first trimester of pregnancy.
Edwards, R; Fuchs, E; Kerr, L; Phillips-Howard, PA; Schildknecht, J; Steffen, R; Vanhauwere, B, 1998
)
0.3
" The pharmacokinetic data, however, showed that they are of similar profile, except in adverse features and contraindications, and values like their half-life (t1/2) where the long (t1/2) in drugs like sulphadoxine-pyrimethamine endows them with suppressive-cure feature, especially against recrudescent strains."( Comparative efficacy and safety of chloroquine and alternative antimalarial drugs: a meta-analysis from six African countries.
Makonnen, E; Mengesha, T, 1999
)
0.3
" Pharmacokinetic profile demonstrates that all these drugs have similar therapeutic effects, but differ in their adverse reactions, contraindications, and half-life."( Comparative efficacy and safety of chloroquine and alternative antimalarial drugs: a meta-analysis from six African countries.
Makonnen, E; Mengesha, T, 1999
)
0.3
" There were no adverse effects experienced by the patients."( A safety and efficacy trial of artesunate, sulphadoxine-pyrimethamine and primaquine in P falciparum malaria.
Faizal, HM; Fernando, WP; Galappaththy, G; Weerasinghe, KL; Wickremasinghe, AR; Wickremasinghe, DR, 2002
)
0.31
"The combination of artesunate, S + P and primaquine was found to be effective and safe in the treatment of uncomplicated P falciparum malaria."( A safety and efficacy trial of artesunate, sulphadoxine-pyrimethamine and primaquine in P falciparum malaria.
Faizal, HM; Fernando, WP; Galappaththy, G; Weerasinghe, KL; Wickremasinghe, AR; Wickremasinghe, DR, 2002
)
0.31
" Severe malaria in rural areas of Sudan, where facilities for the safe and effective use of parenteral quinine are lacking, is a frequent problem."( Descriptive study on the efficacy and safety of artesunate suppository in combination with other antimalarials in the treatment of severe malaria in Sudan.
Alkadru, AM; Awad, MI; Baraka, OZ; Behrens, RH; Eltayeb, IB, 2003
)
0.32
" Chemoprophylaxis or intermittent preventive treatment (IPT) with an effective antimalarial can ameliorate the adverse effects of malaria during pregnancy."( Safety, efficacy and determinants of effectiveness of antimalarial drugs during pregnancy: implications for prevention programmes in Plasmodium falciparum-endemic sub-Saharan Africa.
Nahlen, B; Newman, RD; Parise, ME; Slutsker, L; Steketee, RW, 2003
)
0.32
" Adverse events and clinical and parasitological outcomes were recorded."( A randomised trial to assess the safety and efficacy of artemether-lumefantrine (Coartem) for the treatment of uncomplicated Plasmodium falciparum malaria in Rwanda.
D'Alessandro, U; Fanello, CI; Karema, C; Ngamije, D; van Doren, W; Van Overmeir, C, 2007
)
0.34
" Additionally, reports of adverse effects were solicited and monitored during follow-up visits."( Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial.
Browne, E; Bruce, J; Chandramohan, D; Greenwood, B; Randal, A; Tagbor, H, 2006
)
0.33
" No serious liver toxic effects or white-blood-cell dyscrasias were noted."( Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial.
Browne, E; Bruce, J; Chandramohan, D; Greenwood, B; Randal, A; Tagbor, H, 2006
)
0.33
" This review evaluates the toxicity data of sulfadoxine/pyrimethamine, including severe cutaneous adverse reactions, teratogenicity and alterations in bilirubin metabolism."( Safety and toxicity of sulfadoxine/pyrimethamine: implications for malaria prevention in pregnancy using intermittent preventive treatment.
Newman, RD; Parise, ME; Peters, PJ; Thigpen, MC, 2007
)
0.34
" Secondary end-points were incidence of adverse events, mean haemoglobin concentration and prevalence of parasites carrying markers of resistance to SP."( A trial of the efficacy, safety and impact on drug resistance of four drug regimens for seasonal intermittent preventive treatment for malaria in Senegalese children.
Bâ, el H; Boulanger, D; Cissé, B; Gaye, O; Greenwood, B; Hallett, R; Lines, J; Milligan, P; Simondon, F; Simondon, K; Sokhna, C; Sutherland, C; Targett, G; Trape, JF, 2008
)
0.35
" When used for prophylaxis, Amodiaquine (AQ) was associated with agranulocytosis but is considered safe for treatment and is increasingly being used in Africa."( Sulfadoxine-pyrimethamine-based combinations for malaria: a randomised blinded trial to compare efficacy, safety and selection of resistance in Malawi.
Bell, DJ; Molyneux, ME; Mukaka, M; Nyirongo, SK; Plowe, CV; Ward, SA; Winstanley, PA; Zijlstra, EE, 2008
)
0.35
" No significant adverse event attributable to any of the study drugs was found."( Efficacy, safety, and selection of molecular markers of drug resistance by two ACTs in Mali.
Dama, S; Dembele, D; Dicko, A; Djimdé, AA; Doumbo, OK; Fofana, B; Ouologuem, D; Sagara, I; Sidibe, B; Toure, S, 2008
)
0.35
" Participants were actively monitored for adverse events for the first 14 days after each treatment, and then passively followed until their next study medication treatment, or withdrawal from study."( Safety and tolerability of combination antimalarial therapies for uncomplicated falciparum malaria in Ugandan children.
Clark, TD; Dorsey, G; Jagannathan, P; Kamya, MR; Maiteki-Sebuguzi, C; Njama-Meya, D; Nzarubara, B; Rosenthal, PJ; Staedke, SG; Talisuna, AO; Yau, VM, 2008
)
0.35
" The main outcome measures for safety were incidences of post-treatment clinical and laboratory adverse events."( Artemisinin-naphthoquine combination (ARCO) therapy for uncomplicated falciparum malaria in adults of Papua New Guinea: a preliminary report on safety and efficacy.
Geita, J; Hiawalyer, G; Hombhanje, FW; Jones, R; Kevau, I; Kuanch, C; Linge, D; Masta, A; Sapuri, M; Saweri, A; Toraso, S, 2009
)
0.35
" Both regimens were well tolerated with no serious adverse events."( Artemisinin-naphthoquine combination (ARCO) therapy for uncomplicated falciparum malaria in adults of Papua New Guinea: a preliminary report on safety and efficacy.
Geita, J; Hiawalyer, G; Hombhanje, FW; Jones, R; Kevau, I; Kuanch, C; Linge, D; Masta, A; Sapuri, M; Saweri, A; Toraso, S, 2009
)
0.35
" Data from the trials for incidence of clinical malaria, risk of anaemia (packed-cell volume <25% or haemoglobin <80 g/L), and incidence of hospital admissions and adverse events in infants up to 12 months of age were reanalysed by use of standard outcome definitions and time periods."( Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials.
Adjei, S; Alonso, P; Anemana, S; Aponte, JJ; Breckenridge, A; Carneiro, I; Chandramohan, D; Critchley, J; Danquah, I; Dodoo, A; Egan, A; Greenwood, B; Grobusch, MP; Issifou, S; Kobbe, R; Kremsner, PG; Lell, B; Macete, E; May, J; Menendez, C; Mockenhaupt, F; Mshinda, H; Newman, RD; Owusu-Agyei, S; Premji, Z; Sanz, S; Schellenberg, D; Sevene, E; Slutsker, L; Soulaymani-Becheikh, R; Tanner, M; Winstanley, P, 2009
)
0.35
" None of three serious dermatological adverse events in the IPTi group were judged related to study treatment compared with one of 13 in the placebo group."( Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials.
Adjei, S; Alonso, P; Anemana, S; Aponte, JJ; Breckenridge, A; Carneiro, I; Chandramohan, D; Critchley, J; Danquah, I; Dodoo, A; Egan, A; Greenwood, B; Grobusch, MP; Issifou, S; Kobbe, R; Kremsner, PG; Lell, B; Macete, E; May, J; Menendez, C; Mockenhaupt, F; Mshinda, H; Newman, RD; Owusu-Agyei, S; Premji, Z; Sanz, S; Schellenberg, D; Sevene, E; Slutsker, L; Soulaymani-Becheikh, R; Tanner, M; Winstanley, P, 2009
)
0.35
"IPTi with sulfadoxine-pyrimethamine was safe and efficacious across a range of malaria transmission settings, suggesting that this intervention is a useful contribution to malaria control."( Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials.
Adjei, S; Alonso, P; Anemana, S; Aponte, JJ; Breckenridge, A; Carneiro, I; Chandramohan, D; Critchley, J; Danquah, I; Dodoo, A; Egan, A; Greenwood, B; Grobusch, MP; Issifou, S; Kobbe, R; Kremsner, PG; Lell, B; Macete, E; May, J; Menendez, C; Mockenhaupt, F; Mshinda, H; Newman, RD; Owusu-Agyei, S; Premji, Z; Sanz, S; Schellenberg, D; Sevene, E; Slutsker, L; Soulaymani-Becheikh, R; Tanner, M; Winstanley, P, 2009
)
0.35
"The conventional markers of toxicity in serum, oxidative stress parameters in tissue homogenates, histology of liver and alterations in global transcriptomic expression were evaluated to study the toxic effects of AQ and SP in isolation and in combination."( A study of toxicity and differential gene expression in murine liver following exposure to anti-malarial drugs: amodiaquine and sulphadoxine-pyrimethamine.
Mishra, SK; Rath, SK; Singh, P, 2011
)
0.37
" In the second and third trimesters, AL was not associated with increased adverse pregnancy outcomes as compared with quinine or sulphadoxine-pyrimethamine, showed improved tolerability relative to quinine, and its efficacy was non-inferior to quinine."( A systematic review of the safety and efficacy of artemether-lumefantrine against uncomplicated Plasmodium falciparum malaria during pregnancy.
D'Alessandro, U; Hamed, K; Juma, E; Kayentao, K; Manyando, C; Okafor, HU, 2012
)
0.38
" There were no differences between the study arms in the incidence of serious adverse events during the intervention and the incidence of malaria during the 1-y period after the intervention was stopped."( Protective efficacy and safety of three antimalarial regimens for the prevention of malaria in young Ugandan children: a randomized controlled trial.
Achan, J; Aweeka, FT; Bigira, V; Clark, TD; Dorsey, G; Havlir, DV; Huang, L; Kamya, MR; Kapisi, J; Kinara, S; Muhindo, MK; Mwangwa, F; Osterbauer, B; Rosenthal, PJ, 2014
)
0.4
" The aim of this study was to evaluate the clinical and biological adverse effects of the combination of sulfadoxine-pyrimethamine."( Treatment of Congenital Toxoplasmosis: Safety of the Sulfadoxine-Pyrimethamine Combination in Children Based on a Method of Causality Assessment.
Charpiat, B; Corvaisier, S; Dupont, D; Leboucher, G; Peyron, F; Teil, J; Vial, T; Wallon, M, 2016
)
0.43
"Sixty-five children treated for 1 year with a combination of sulfadoxine-pyrimethamine (1 dose every 10 days) for congenital toxoplasmosis were followed up to evaluate abnormal hematological values and potential adverse events using a standardized method of causality assessment."( Treatment of Congenital Toxoplasmosis: Safety of the Sulfadoxine-Pyrimethamine Combination in Children Based on a Method of Causality Assessment.
Charpiat, B; Corvaisier, S; Dupont, D; Leboucher, G; Peyron, F; Teil, J; Vial, T; Wallon, M, 2016
)
0.43
"8%) presented at least 1 adverse clinical event that was nonspecific, such as diarrhea on the day of drug administration, vomiting and agitation."( Treatment of Congenital Toxoplasmosis: Safety of the Sulfadoxine-Pyrimethamine Combination in Children Based on a Method of Causality Assessment.
Charpiat, B; Corvaisier, S; Dupont, D; Leboucher, G; Peyron, F; Teil, J; Vial, T; Wallon, M, 2016
)
0.43
" Occurrences of congenital anomalies, deaths, and serious adverse events were comparable in neonates for both groups."( Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial.
Ayoub, A; Duparc, S; Kamiza, S; Kimani, J; Orrico, R; Phiri, K; Robbins, J; Rojo, R; Vandenbroucke, P, 2016
)
0.43
"A surveillance system was established to record all deaths and all malaria cases diagnosed at health facilities and a pharmacovigilance system was established to detect adverse drug reactions."( Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial.
Ba, EH; Cairns, M; Cissé, B; Fall, FB; Faye, B; Gaye, O; Gomis, JF; Greenwood, BM; Kouevijdin, E; Milligan, PJ; Molez, JF; NDiaye, JL; Ndour, CT; Niane, FK; Rogier, C; Sokhna, C; Trape, JF, 2016
)
0.43
" No serious adverse events attributable to the intervention were detected, despite a high level of surveillance."( Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial.
Ba, EH; Cairns, M; Cissé, B; Fall, FB; Faye, B; Gaye, O; Gomis, JF; Greenwood, BM; Kouevijdin, E; Milligan, PJ; Molez, JF; NDiaye, JL; Ndour, CT; Niane, FK; Rogier, C; Sokhna, C; Trape, JF, 2016
)
0.43
" Monthly IPT-DP was associated with fewer serious adverse events than placebo, daily co-trimoxazole, or monthly SP."( Safety, tolerability, and efficacy of repeated doses of dihydroartemisinin-piperaquine for prevention and treatment of malaria: a systematic review and meta-analysis.
Dorsey, G; Gutman, J; Kovacs, S; Stergachis, A; Ter Kuile, FO, 2017
)
0.46
"In endemic areas, malaria and its adverse effects in schoolchildren may be prevented by intermittent preventive treatment (IPTsc)."( Efficacy and safety of intermittent preventive treatment in schoolchildren with sulfadoxine/pyrimethamine (SP) and SP plus piperaquine in Democratic Republic of the Congo: a randomised controlled trial.
da Luz, RI; Doua, JY; Lutumba, P; Matangila, JR; Mitashi, P; Van Geertruyden, JP, 2017
)
0.46
" Here we present the side effect profile of MQ for the treatment of uncomplicated malaria on the Thai-Myanmar/Cambodia borders."( Adverse effects of mefloquine for the treatment of uncomplicated malaria in Thailand: A pooled analysis of 19, 850 individual patients.
Lee, SJ; Luxemburger, C; Nosten, F; Price, RN; Ter Kuile, FO, 2017
)
0.46
" For quinine, clindamycin, and mefloquine and the combinations of sulfadoxine+pyrimethamine and artemether+lumefantrine, there are reports (including studies without internal comparison groups) that combined describe 304 to >1100 exposures of women in the first trimester for each drug with no conclusive evidence of adverse effects on pregnancy at therapeutic doses."( Animal Embryotoxicity Studies of Key Non-Artemisinin Antimalarials and Use in Women in the First Trimester.
Clark, RL, 2017
)
0.46
" After exclusion of blue urine, adverse events were similar across all groups (59 [74%] of 80 participants had 162 adverse events overall, 145 [90%] of which were mild)."( Efficacy and safety of primaquine and methylene blue for prevention of Plasmodium falciparum transmission in Mali: a phase 2, single-blind, randomised controlled trial.
Bousema, T; Bradley, J; Brown, JM; Chen, I; Diarra, K; Diawara, H; Dicko, A; Drakeley, C; Gosling, R; Hwang, J; Issiaka, D; Keita, S; Kone, DT; Lanke, K; Mahamar, A; McCulloch, C; Müller, O; Roh, ME; Sanogo, K; Soumare, HM; Srinivasan, V; Stone, WJR; Traore, SF, 2018
)
0.48
"Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by the World Health Organization for the prevention of malaria in pregnancy (MIP)-associated adverse outcomes in high burden areas."( Safety and efficacy of intermittent presumptive treatment with sulfadoxine-pyrimethamine using rapid diagnostic test screening and treatment with dihydroartemisinin-piperaquine at the first antenatal care visit (IPTp-SP+): study protocol for a randomized
Champo, D; Chongwe, G; Ippolito, MM; Kabuya, JB; Manyando, C; Mulenga, M; Mwakazanga, D; Sikalima, J; Tende, C; Young, AMP, 2021
)
0.62
" Secondary endpoints include incident MIP at other time points, placental malaria, congenital malaria, hemoglobin trends, birth outcomes, and incidence of adverse events in infants up to the first birthday."( Safety and efficacy of intermittent presumptive treatment with sulfadoxine-pyrimethamine using rapid diagnostic test screening and treatment with dihydroartemisinin-piperaquine at the first antenatal care visit (IPTp-SP+): study protocol for a randomized
Champo, D; Chongwe, G; Ippolito, MM; Kabuya, JB; Manyando, C; Mulenga, M; Mwakazanga, D; Sikalima, J; Tende, C; Young, AMP, 2021
)
0.62
"In drug trials, adverse events (AEs) burden can induce treatment non-adherence or discontinuation."( Effect of adverse events on non-adherence and study non-completion in malaria chemoprevention during pregnancy trial: A nested case control study.
Chirwa, T; Divala, T; Kazembe, L; Laufer, MK; Mathanga, D; Mukaka, M; Patson, N; Peterson, I, 2022
)
0.72
" No severe adverse events associated with the MDA were identified in the pilot; there were severe adverse events in a separate, subsequent campaign."( Acceptability, Feasibility, Drug Safety, and Effectiveness of a Pilot Mass Drug Administration with a Single Round of Sulfadoxine-Pyrimethamine Plus Primaquine and Indoor Residual Spraying in Communities with Malaria Transmission in Haiti, 2018.
Ashton, R; Battle, KE; Cameron, E; Chang, MA; Cohen, J; Dalexis, PE; Desir, L; Dismer, AM; Drakeley, C; Druetz, T; Eisele, TP; Fouché, B; Hamre, KES; Herman, C; Holmes, K; Impoinvil, D; Lafortune, W; Lemoine, JF; Mérilien, JB; Noland, GS; Pothin, E; Rogier, E; Stresman, G; Telfort, MA; van den Hoogen, L; Williamson, J; Young, AJ, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
"To develop a population pharmacokinetic model for pyrimethamine (PYR) and sulfadoxine (SDX) in children with congenital toxoplasmosis."( Population pharmacokinetics of pyrimethamine and sulfadoxine in children with congenital toxoplasmosis.
Chemla, C; Dupouy, D; Jaussaud, R; Leroux, B; Millart, H; Pinon, JM; Quereux, C; Rémy, G; Simon, N; Trenque, T; Urien, S; Villena, I, 2004
)
0.32
" Population pharmacokinetic analysis was performed using a nonlinear mixed effects model."( Population pharmacokinetics of pyrimethamine and sulfadoxine in children with congenital toxoplasmosis.
Chemla, C; Dupouy, D; Jaussaud, R; Leroux, B; Millart, H; Pinon, JM; Quereux, C; Rémy, G; Simon, N; Trenque, T; Urien, S; Villena, I, 2004
)
0.32
"To explore possible pharmacokinetic interactions between CQ and S/P during co-administration, and to determine their bioavailability in the locally made Homapak compared to the Good Manufacturing Practice (GMP) made formulations."( Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda.
Anokbonggo, WW; Gustafsson, LL; Hellgren, U; Lundblad, MS; Mahindi, M; Ntale, M; Obua, C; Ogwal-Okeng, JW, 2006
)
0.33
" Plasma samples were followed for 21 days, analysed by HPLC-UV methods, with pharmacokinetic modeling using the WinNonlin software."( Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda.
Anokbonggo, WW; Gustafsson, LL; Hellgren, U; Lundblad, MS; Mahindi, M; Ntale, M; Obua, C; Ogwal-Okeng, JW, 2006
)
0.33
" No significant differences were observed in the other pharmacokinetic parameters of S, P and CQ when given together or separately."( Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda.
Anokbonggo, WW; Gustafsson, LL; Hellgren, U; Lundblad, MS; Mahindi, M; Ntale, M; Obua, C; Ogwal-Okeng, JW, 2006
)
0.33
"There were no pharmacokinetic interactions between CQ, S and P when the compounds were given together, however, more investigations would be needed to explore this further."( Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda.
Anokbonggo, WW; Gustafsson, LL; Hellgren, U; Lundblad, MS; Mahindi, M; Ntale, M; Obua, C; Ogwal-Okeng, JW, 2006
)
0.33
"Our objective was to characterize the pharmacokinetic properties of sulfadoxine-pyrimethamine in African adults and children with acute falciparum malaria."( Sulfadoxine-pyrimethamine pharmacokinetics in malaria: pediatric dosing implications.
Barnes, KI; Evans, A; Little, F; Smith, PJ; Watkins, WM; White, NJ, 2006
)
0.33
"In a prospective multicenter pharmacokinetic study in 307 patients with acute falciparum malaria, capillary blood concentrations of sulfadoxine and pyrimethamine were determined at 9 visits over a period of 42 days by mass spectrometry."( Sulfadoxine-pyrimethamine pharmacokinetics in malaria: pediatric dosing implications.
Barnes, KI; Evans, A; Little, F; Smith, PJ; Watkins, WM; White, NJ, 2006
)
0.33
" Among prepartum women, the median half-life for sulfadoxine was significantly shorter than that observed in postpartum women (148 vs 256 h; P<."( Pharmacokinetics of sulfadoxine-pyrimethamine in HIV-infected and uninfected pregnant women in Western Kenya.
Ayisi, JG; Green, MD; Kager, PA; Nahlen, BL; Nettey, H; Parise, ME; Steketee, R; van Eijk, AM; van Ter Kuile, FO, 2007
)
0.34
"Pregnancy significantly modifies the disposition of SP, whereas HIV status has little influence on pharmacokinetic parameters in pregnant women."( Pharmacokinetics of sulfadoxine-pyrimethamine in HIV-infected and uninfected pregnant women in Western Kenya.
Ayisi, JG; Green, MD; Kager, PA; Nahlen, BL; Nettey, H; Parise, ME; Steketee, R; van Eijk, AM; van Ter Kuile, FO, 2007
)
0.34
"To determine the pharmacokinetic disposition of sulfadoxine (SDOX) and pyrimethamine (PYR) when administered as intermittent presumptive treatment during pregnancy (IPTp) for malaria, 30 Papua New Guinean women in the second or third trimester of pregnancy and 30 age-matched nonpregnant women were given a single dose of 1,500 mg of SDOX plus 75 mg of pyrimethamine PYR."( Pharmacokinetic properties of sulfadoxine-pyrimethamine in pregnant women.
Baiwog, F; Davis, TM; Gomorrai, S; Ilett, KF; Karunajeewa, HA; Law, I; Mueller, I; Page-Sharp, M; Rogerson, S; Salman, S; Siba, P, 2009
)
0.35
" SP pharmacokinetic parameters differed significantly among the study sites."( Pharmacokinetics of sulfadoxine and pyrimethamine in intermittent preventive treatment of malaria in pregnancy.
Adam, I; Barnes, KI; Cassam, Y; Doumbo, O; Guirou, E; Kayentao, K; Little, F; Mauff, K; Nyunt, MM; Smith, P; Sullivan, D; Thuma, P; Traore, B; van Dijk, J, 2010
)
0.36
" However, information on pharmacokinetic disposition of SDX-pyrimethamine in children is limited."( Pharmacokinetic disposition of sulfadoxine in children with acute uncomplicated falciparum malaria treated with sulfadoxine-pyrimethamine in South West Nigeria.
Gbotosho, GO; Happi, CT; Oduola, A; Sijuade, A; Sowunmi, A, 2012
)
0.38
" We developed population pharmacokinetic (PK) models to describe the distribution of sulfadoxine (SDX) and pyrimethamine (PYM) in children with uncomplicated malaria in Malawi."( Population pharmacokinetics of sulfadoxine and pyrimethamine in Malawian children with malaria.
Bell, DJ; Molyneux, ME; Mukaka, M; Nyirongo, SK; Ward, SA; Winstanley, PA, 2011
)
0.37
" Because of limited pharmacokinetic data and suggestions that higher milligram/kilogram pediatric doses than recommended should be considered, we assessed SDX/PYR disposition, randomized to conventional (25/1."( Pharmacokinetic properties of conventional and double-dose sulfadoxine-pyrimethamine given as intermittent preventive treatment in infancy.
Davis, TM; Griffin, S; Ilett, KF; Kose, K; Moore, B; Mueller, I; Pitus, N; Salman, S; Siba, P; Winmai, J, 2011
)
0.37
" Yet, limited data is available on pharmacokinetic interactions between these drugs."( Effects of amodiaquine and artesunate on sulphadoxine-pyrimethamine pharmacokinetic parameters in children under five in Mali.
Barnes, KI; Beavogui, AH; Djimde, AA; Doumbo, OK; Evans, A; Fredericks, A; Maiga, H; Sangare, CP; Smith, P; Tekete, MM; Toure, S; Traore, ZI, 2011
)
0.37
" Exactly 100 μl of capillary blood was collected onto filter paper before drug administration at day 0 and at days 1, 3, 7, 14, 21 and 28 after drug administration for analysis of sulphadoxine and pyrimethamine pharmacokinetic parameters."( Effects of amodiaquine and artesunate on sulphadoxine-pyrimethamine pharmacokinetic parameters in children under five in Mali.
Barnes, KI; Beavogui, AH; Djimde, AA; Doumbo, OK; Evans, A; Fredericks, A; Maiga, H; Sangare, CP; Smith, P; Tekete, MM; Toure, S; Traore, ZI, 2011
)
0.37
"001) and thus elimination half-life (3."( Effects of amodiaquine and artesunate on sulphadoxine-pyrimethamine pharmacokinetic parameters in children under five in Mali.
Barnes, KI; Beavogui, AH; Djimde, AA; Doumbo, OK; Evans, A; Fredericks, A; Maiga, H; Sangare, CP; Smith, P; Tekete, MM; Toure, S; Traore, ZI, 2011
)
0.37
"The aim of the present study was to compare the pharmacokinetic profiles between a new generic and the branded reference formulation of sulfadoxine/pyrimethamine FDC tablets, and to assess the bioequivalence of the 2 products in healthy Chinese volunteers."( Pharmacokinetic properties and bioequivalence of two sulfadoxine/pyrimethamine fixed-dose combination tablets: a parallel-design study in healthy Chinese male volunteers.
Jia, JY; Liu, GY; Liu, Y; Liu, YM; Lu, C; Pu, HH; Song, YX; Yu, C; Zhang, HC; Zhang, KE; Zheng, QS; Zhu, JM, 2012
)
0.38
" Pharmacokinetic properties (C(max), AUC(0-72), AUC(0-168), and T(max)) were calculated and analyzed statistically."( Pharmacokinetic properties and bioequivalence of two sulfadoxine/pyrimethamine fixed-dose combination tablets: a parallel-design study in healthy Chinese male volunteers.
Jia, JY; Liu, GY; Liu, Y; Liu, YM; Lu, C; Pu, HH; Song, YX; Yu, C; Zhang, HC; Zhang, KE; Zheng, QS; Zhu, JM, 2012
)
0.38
"The findings from this single-dose (1500/75-mg) study suggest that the test and reference formulations of sulfadoxine/pyrimethamine FDC 500/25-mg tablet have similar pharmacokinetic profiles both in terms of rate and extent of absorption."( Pharmacokinetic properties and bioequivalence of two sulfadoxine/pyrimethamine fixed-dose combination tablets: a parallel-design study in healthy Chinese male volunteers.
Jia, JY; Liu, GY; Liu, Y; Liu, YM; Lu, C; Pu, HH; Song, YX; Yu, C; Zhang, HC; Zhang, KE; Zheng, QS; Zhu, JM, 2012
)
0.38
" Compartmental pharmacokinetic models were developed using a population-based approach."( Population pharmacokinetics, tolerability, and safety of dihydroartemisinin-piperaquine and sulfadoxine-pyrimethamine-piperaquine in pregnant and nonpregnant Papua New Guinean women.
Batty, KT; Benjamin, JM; Davis, TM; Lorry, L; Moore, BR; Mueller, I; Page-Sharp, M; Robinson, LJ; Salman, S; Siba, PM; Tawat, S; Yadi, G, 2015
)
0.42
"The ongoing development of new antimalarial drugs and the increasing use of controlled human malaria infection (CHMI) studies to investigate their activity in early-stage clinical trials require the development of methods to analyze their pharmacodynamic effect."( Evaluating the pharmacodynamic effect of antimalarial drugs in clinical trials by quantitative PCR.
Baker, M; Marquart, L; McCarthy, JS; O'Rourke, P, 2015
)
0.42
" However, pharmacokinetic studies in pregnancy show variable and often contradictory findings."( Trimester-Specific Population Pharmacokinetics and Other Correlates of Variability in Sulphadoxine-Pyrimethamine Disposition Among Ugandan Pregnant Women.
Bisaso, KR; Byamugisha, J; Mukonzo, JK; Ntale, M; Obua, C; Odia, G; Odongo, CO; Ojara, FW, 2015
)
0.42
" Population pharmacokinetic analysis was done using NONMEM software."( Trimester-Specific Population Pharmacokinetics and Other Correlates of Variability in Sulphadoxine-Pyrimethamine Disposition Among Ugandan Pregnant Women.
Bisaso, KR; Byamugisha, J; Mukonzo, JK; Ntale, M; Obua, C; Odia, G; Odongo, CO; Ojara, FW, 2015
)
0.42
" Between trimesters, statistically significant differences in central volumes of distribution (V(2)) were observed for both drugs, while differences in the distribution half-life and the terminal elimination half-life were observed for pyrimethamine and sulphadoxine, respectively."( Trimester-Specific Population Pharmacokinetics and Other Correlates of Variability in Sulphadoxine-Pyrimethamine Disposition Among Ugandan Pregnant Women.
Bisaso, KR; Byamugisha, J; Mukonzo, JK; Ntale, M; Obua, C; Odia, G; Odongo, CO; Ojara, FW, 2015
)
0.42
" Data from 98 women during pregnancy and 77 after delivery in four African countries were analyzed using nonlinear mixed-effects modeling to characterize the effects of pregnancy, postpartum duration, and other covariates such as body weight and hematocrit on sulfadoxine/pyrimethamine pharmacokinetic properties."( Pharmacokinetics of Sulfadoxine and Pyrimethamine for Intermittent Preventive Treatment of Malaria During Pregnancy and After Delivery.
Adam, I; Barnes, KI; de Kock, M; Denti, P; Nyunt, MM; Tarning, J; Workman, L, 2017
)
0.46
"Despite extensive use and accumulated evidence of safety, there have been few pharmacokinetic studies from which appropriate chloroquine (CQ) dosing regimens could be developed specifically for pregnant women."( Optimal antimalarial dose regimens for chloroquine in pregnancy based on population pharmacokinetic modelling.
Baiwog, F; Davis, TME; Ilett, KF; Karunajeewa, HA; Kose, K; Mueller, I; Page-Sharp, M; Rogerson, SJ; Salman, S; Siba, PM, 2017
)
0.46
" This study determined the pharmacokinetic characteristics of the mefloquine stereoisomers and the metabolite carboxymefloquine (CMQ) when given as IPTp in pregnant women."( Population Pharmacokinetics of Mefloquine Intermittent Preventive Treatment for Malaria in Pregnancy in Gabon.
Akerey-Diop, D; Basra, A; Geditz, M; Gonzalez, R; Hofmann, U; Kerb, R; Kremsner, PG; Lehr, T; Mackanga, JR; Matsiegui, PB; Menendez, C; Mombo-Ngoma, G; Ramharter, M; Schwab, M; Wojtyniak, JG; Würbel, H; Zoleko Manego, R, 2019
)
0.51

Compound-Compound Interactions

ExcerptReferenceRelevance
" From September to December 1998, 598 children with uncomplicated malaria were treated; 135 received chloroquine (CQ) alone, 276 received pyrimethamine/sulfadoxine (Fansidar, PSD) alone, 113 received PSD with a single dose of artesunate (PSD + 1ART) and 74 received PSD combined with three doses of artesunate (PSD + 3ART)."( Parasitaemia and gametocytaemia after treatment with chloroquine, pyrimethamine/sulfadoxine, and pyrimethamine/sulfadoxine combined with artesunate in young Gambians with uncomplicated malaria.
Coleman, R; Doherty, T; Jawara, M; Targett, G; von Seidlein, L; Walraven, G, 2001
)
0.31
"To assess the effectiveness of chloroquine or amodiaquine given with sulfadoxine-pyrimethamine to treat uncomplicated falciparum malaria."( Chloroquine or amodiaquine combined with sulfadoxine-pyrimethamine for treating uncomplicated malaria.
McIntosh, HM, 2001
)
0.31
"Randomised and quasi-randomised trials of chloroquine or amodiaquine given with sulfadoxine-pyrimethamine compared with either drug alone in adults or children with confirmed uncomplicated falciparum malaria."( Chloroquine or amodiaquine combined with sulfadoxine-pyrimethamine for treating uncomplicated malaria.
McIntosh, HM, 2001
)
0.31
"In areas where chloroquine or amodiaquine are still effective, despite some degree of resistance, using these drugs in combination with sulfadoxine-pyrimethamine, rather than sulfadoxine-pyrimethamine alone, may make people feel better faster and improve sustained parasites clearance."( Chloroquine or amodiaquine combined with sulfadoxine-pyrimethamine for treating uncomplicated malaria.
McIntosh, HM, 2001
)
0.31
" Overall 14,017 (85%) individuals living in the study area were treated with either placebo or sulfadoxine-pyrimethamine (SP) combined with a single dose of artesunate (AS)."( The effect of mass administration of sulfadoxine-pyrimethamine combined with artesunate on malaria incidence: a double-blind, community-randomized, placebo-controlled trial in The Gambia.
Alexander, N; Bennett, S; Coleman, R; De Martin, S; Deen, JL; Doherty, JF; Drakeley, C; Greenwood, BM; Jawara, M; Lindsay, SW; Manneh, F; McAdam, KP; Milligan, PJ; Okunoye, K; Olliaro, P; Pinder, M; Schim van der Loeff, M; Targett, GA; von Seidlein, L; Walraven, G,
)
0.13
"The effectiveness of chloroquine or sulfadoxine-pyrimethamine administered with artesunate for treating uncomplicated falciparum malaria was assessed in 2 Vietnamese provinces where the sensitivity of parasites in vitro to conventional therapies had increased with the removal of drug pressure."( Treatment of uncomplicated falciparum malaria in southern Vietnam: can chloroquine or sulfadoxine-pyrimethamine be reintroduced in combination with artesunate?
Cox-Singh, J; Davis, TM; Doan, HN; Hewitt, S; Le, DC; Nguyen, MH; Nguyen, TH; Tran, BK; Tran, QT; Vo, NP, 2003
)
0.32
" In 2002, we assessed the efficacy of SP alone and combined with amodiaquine (AQ/SP) or chloroquine (CQ/SP) in Ugandan children with uncomplicated falciparum malaria."( Efficacy of sulphadoxine-pyrimethamine alone or combined with amodiaquine or chloroquine for the treatment of uncomplicated falciparum malaria in Ugandan children.
Bakyaita, N; D'Alessandro, U; Egwang, TG; Langi, P; Mutabingwa, TK; Nalunkuma-Kazibwe, A; Talisuna, AO; Van Marck, E; Watkins, WW, 2004
)
0.32
" At a meeting in Port Moresby in October 1997, it was decided to explore a possible change of the current first-line treatment of uncomplicated malaria with chloroquine alone (amodiaquine for children under five years) to chloroquine or amodiaquine in combination with sulfadoxine-pyrimethamine (S-P)."( Therapeutic efficacy of chloroquine or amodiaquine in combination with sulfadoxine-pyrimethamine for uncomplicated falciparum malaria in Papua New Guinea.
Bulungol, P; Hwaihwanje, I; Jayatilaka, KD; Kemiki, A; Taviri, J,
)
0.13
"To overcome the declining efficacy of the 4-aminoquinolines in Papua New Guinea, sulfadoxine/pyrimethamine (SP) was combined with the 4-aminoquinolines as the first line treatment for falciparum malaria since 2000."( Rapid selection of dhfr mutant allele in Plasmodium falciparum isolates after the introduction of sulfadoxine/pyrimethamine in combination with 4-aminoquinolines in Papua New Guinea.
Björkman, A; Hwaihwanje, I; Kaneko, A; Kobayakawa, T; Mita, T; Osawa, H; Takahashi, N; Tanabe, K; Tsukahara, T, 2006
)
0.33
"Artesunate (AS) in combination with sulfadoxine/pyrimethamine (SP) is the first-line therapy for management of uncomplicated Plasmodium falciparum malaria in Sudan."( Pharmacokinetics of artesunate alone and in combination with sulfadoxine/pyrimethamine in healthy Sudanese volunteers.
Awad, AI; Elamin, SB; Matar, KM, 2014
)
0.4
" Furthermore, doxycycline has anti-malarial properties and is already recommended as prophylaxis for travellers and for treatment of falciparum malaria in combination with other anti-malarial drugs."( Has doxycycline, in combination with anti-malarial drugs, a role to play in intermittent preventive treatment of Plasmodium falciparum malaria infection in pregnant women in Africa?
Boxberger, M; Gaillard, T; Madamet, M; Pradines, B, 2018
)
0.48

Bioavailability

ExcerptReferenceRelevance
"The bioavailability of two oral preparations of pyrimethamine-sulfadoxine are compared in a randomised cross-over study."( A study of the comparative bioavailability of pyrimethamine-sulfadoxine obtained from two oral preparations.
Mberu, E; Murphy, SA, 1994
)
0.29
"The main objective of this work was to assess the relative bioavailability of two tablet formulations containing sulfadoxine/pyrimethamine (SP) and marketed in Tanzania."( Existence of antimalarial formulations with low bioavailability in Tanzania.
Ericsson, O; Gustafsson, LL; Justin-Temu, M; Massele, A; Minzi, OM, 2006
)
0.33
"To explore possible pharmacokinetic interactions between CQ and S/P during co-administration, and to determine their bioavailability in the locally made Homapak compared to the Good Manufacturing Practice (GMP) made formulations."( Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda.
Anokbonggo, WW; Gustafsson, LL; Hellgren, U; Lundblad, MS; Mahindi, M; Ntale, M; Obua, C; Ogwal-Okeng, JW, 2006
)
0.33
" The relative bioavailability of CQ and S in Homapak showed bioequivalence to reference formulations."( Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda.
Anokbonggo, WW; Gustafsson, LL; Hellgren, U; Lundblad, MS; Mahindi, M; Ntale, M; Obua, C; Ogwal-Okeng, JW, 2006
)
0.33
" We summarized the data under the following themes: content and dissolution; relative bioavailability of antimalarial products; antimalarial stability and shelf life; general tests on pharmaceutical dosage forms; and the presence of degradation or unidentifiable impurities in formulations."( Antimalarial drug quality in Africa.
Amin, AA; Kokwaro, GO, 2007
)
0.34
" The literature was varied in the quality and breadth of data presented, with most bioavailability studies poorly designed and executed."( Antimalarial drug quality in Africa.
Amin, AA; Kokwaro, GO, 2007
)
0.34
" There was a 32% reduction in SDX relative bioavailability with the double dose but no evidence of dose-dependent metabolism."( Pharmacokinetic properties of conventional and double-dose sulfadoxine-pyrimethamine given as intermittent preventive treatment in infancy.
Davis, TM; Griffin, S; Ilett, KF; Kose, K; Moore, B; Mueller, I; Pitus, N; Salman, S; Siba, P; Winmai, J, 2011
)
0.37
"001) in association with a greater clearance relative to bioavailability (73."( Population pharmacokinetics, tolerability, and safety of dihydroartemisinin-piperaquine and sulfadoxine-pyrimethamine-piperaquine in pregnant and nonpregnant Papua New Guinean women.
Batty, KT; Benjamin, JM; Davis, TM; Lorry, L; Moore, BR; Mueller, I; Page-Sharp, M; Robinson, LJ; Salman, S; Siba, PM; Tawat, S; Yadi, G, 2015
)
0.42
" CF fortified with highly bioavailable iron improved iron status but not Hb concentration, despite three-monthly IPT of malaria."( The effect of iron-fortified complementary food and intermittent preventive treatment of malaria on anaemia in 12- to 36-month-old children: a cluster-randomised controlled trial.
Adiossan, LG; Brittenham, GM; Diakité, VG; Glinz, D; Hurrell, RF; N'Goran, EK; Ouattara, M; Righetti, AA; Seifert, B; Utzinger, J; Wegmüller, R; Zimmermann, MB, 2015
)
0.42
" In the split-dose group, mefloquine bioavailability was significantly increased by 5%."( Population Pharmacokinetics of Mefloquine Intermittent Preventive Treatment for Malaria in Pregnancy in Gabon.
Akerey-Diop, D; Basra, A; Geditz, M; Gonzalez, R; Hofmann, U; Kerb, R; Kremsner, PG; Lehr, T; Mackanga, JR; Matsiegui, PB; Menendez, C; Mombo-Ngoma, G; Ramharter, M; Schwab, M; Wojtyniak, JG; Würbel, H; Zoleko Manego, R, 2019
)
0.51

Dosage Studied

ExcerptRelevanceReference
" Dosage data indicated that fatalities had taken higher doses and continued prophylaxis after onset of symptoms."( Serious adverse drug reactions to pyrimethamine-sulphadoxine, pyrimethamine-dapsone and to amodiaquine in Britain.
Phillips-Howard, PA; West, LJ, 1990
)
0.28
" The dosage of mefloquine is 250 mg weekly (1 tablet Lariam) for 4 weeks, followed by 1 tablet every fortnight."( [Malaria in Switzerland].
Fernex, M, 1988
)
0.27
"A sensitive, rapid and selective high-performance liquid chromatographic (HPLC) method has been developed to measure plasma levels of pyrimethamine in human subjects dosed with the antimalarials Fansidar or Fansidar and mefloquine."( Determination of pyrimethamine in human plasma after administration of fansidar of fansidar-mefloquine by means of high-performance liquid chromatography with fluorescence detection.
Timm, U; Weidekamm, E, 1982
)
0.26
"In a randomized trial, a high dosage chloroquine monotherapy (45 mg/kg over 3 days) was compared with combination regimens of sulfadoxine/pyrimethamine and chloroquine/clindamycin for treating Gabonese school children with Plasmodium falciparum malaria."( Sulfadoxine/pyrimethamine or chloroquine/clindamycin treatment of Gabonese school children infected with chloroquine resistant malaria.
Bienzle, U; Graninger, W; Kremsner, PG; Metzger, W; Mordmüller, B, 1995
)
0.29
" This malaria parasite was sensitive to standard dosage of either chloroquine or sulphadoxine-pyrimethamine."( Malaria in Mvumi, central Tanzania and the in vivo response of Plasmodium falciparum to chloroquine and sulphadoxine pyrimethamine.
Mboera, LE; Ndawi, BT; Wakibara, JV, 1997
)
0.3
" In areas where levels of drug resistance and complexity of infections are high, drug dosage and parasite genotyping may be of limited interest in improving the precision of drug efficacy measurement."( Combination of drug level measurement and parasite genotyping data for improved assessment of amodiaquine and sulfadoxine-pyrimethamine efficacies in treating Plasmodium falciparum malaria in Gabonese children.
Aubouy, A; Bakary, M; Cot, M; Deloron, P; Keundjian, A; Le Bras, J; Makita, JR; Mbomat, B; Migot-Nabias, F, 2003
)
0.32
" The dosage schedule led to a rapid clinical response and reduced parasite clearance and fever subsidence times of (31."( Descriptive study on the efficacy and safety of artesunate suppository in combination with other antimalarials in the treatment of severe malaria in Sudan.
Alkadru, AM; Awad, MI; Baraka, OZ; Behrens, RH; Eltayeb, IB, 2003
)
0.32
" To optimize PYR/SDX combination treatment in congenital toxoplasmosis, short dosing intervals in very young low-wight children are probably appropriate."( Population pharmacokinetics of pyrimethamine and sulfadoxine in children with congenital toxoplasmosis.
Chemla, C; Dupouy, D; Jaussaud, R; Leroux, B; Millart, H; Pinon, JM; Quereux, C; Rémy, G; Simon, N; Trenque, T; Urien, S; Villena, I, 2004
)
0.32
"36), there was a significant reduction in hospital admissions for anemia during the month after dosing for both the first and second dose."( Intermittent preventive treatment for malaria control administered at the time of routine vaccinations in Mozambican infants: a randomized, placebo-controlled trial.
Aide, P; Alonso, P; Aponte, JJ; DgeDge, M; Dobaño, C; Espasa, M; Mabunda, S; Macete, E; Mandomando, I; Menendez, C; Sanz, S; Sigauque, B, 2006
)
0.33
" Among HIV-negative women, there was no conclusive additional effect of monthly dosing (2 trials; 24% and 39% resistance)."( Effect of sulfadoxine-pyrimethamine resistance on the efficacy of intermittent preventive therapy for malaria control during pregnancy: a systematic review.
Filler, SJ; ter Kuile, FO; van Eijk, AM, 2007
)
0.34
" However, more frequent dosing is required in HIV-positive women not using cotrimoxazole prophylaxis for opportunistic infections."( Effect of sulfadoxine-pyrimethamine resistance on the efficacy of intermittent preventive therapy for malaria control during pregnancy: a systematic review.
Filler, SJ; ter Kuile, FO; van Eijk, AM, 2007
)
0.34
" We summarized the data under the following themes: content and dissolution; relative bioavailability of antimalarial products; antimalarial stability and shelf life; general tests on pharmaceutical dosage forms; and the presence of degradation or unidentifiable impurities in formulations."( Antimalarial drug quality in Africa.
Amin, AA; Kokwaro, GO, 2007
)
0.34
" The review highlights the common finding in drug quality studies that (i) most antimalarial products pass the basic tests for pharmaceutical dosage forms, such as the uniformity of weight for tablets, (ii) most antimalarial drugs pass the content test and (iii) in vitro product dissolution is the main problem area where most drugs fail to meet required pharmacopoeial specifications, especially with regard to sulfadoxine-pyrimethamine products."( Antimalarial drug quality in Africa.
Amin, AA; Kokwaro, GO, 2007
)
0.34
"5% improvement in the accumulated proportion of patients (1) treated, (2) treated within 24h of illness onset, (3) treated with the recommended antimalarials, (4) treated at an adequate dosage and (5) treated for the correct duration."( Home-based management of fever and malaria treatment practices in Uganda.
Nsungwa-Sabiiti, J; Ogwal-Okeng, J; Pariyo, G; Peterson, S; Petzold, MG; Tomson, G, 2007
)
0.34
"Single-dose SP was a common result of trying to implement the standard 2-dose regimen and was inferior to all other dosing regimens."( Inferiority of single-dose sulfadoxine-pyrimethamine intermittent preventive therapy for malaria during pregnancy among HIV-positive Zambian women.
Chalwe, V; Champo, D; Chilengi, R; Gill, CJ; Hamer, DH; Macleod, WB; Mukwamataba, D; Mwanakasale, V; Mwananyanda, L; Thea, DM, 2007
)
0.34
" However, the optimal dosing regimen in settings in which human immunodeficiency virus (HIV) is highly prevalent among pregnant women remains controversial."( Two-dose versus monthly intermittent preventive treatment of malaria with sulfadoxine-pyrimethamine in HIV-seropositive pregnant Zambian women.
Chalwe, V; Champo, D; Chilengi, R; Gill, CJ; Hamer, DH; Macleod, WB; Mubikayi, L; Mukwamataba, D; Mulele, CK; Mulenga, M; Mwanakasale, V; Mwananyanda, L; Thea, DM, 2007
)
0.34
"1%) were the three main molecules which account for antimalarial self-treatment However the use of these molecules was inappropriate regarding the dosage (41."( [Self-medication in the treatment of acute malaria: study based on users of private health drug stores in Ouagadougou, Burkina Faso].
Diarra, M; Guissou, IP; Ouédraogo, LT; Somé, IT, 2008
)
0.35
"7% respectively for AQ and SP received a dosage higher than the theoretical dosage."( Child age or weight: difficulties related to the prescription of the right dosage of antimalarial combinations to treat children in Senegal.
Lalou, R; Le Hesran, JY; Senghor, P; Souares, A, 2010
)
0.36
"7% agreement between self-reported data and blood drug dosage for amodiaquine treatment."( Self-reported data: a major tool to assess compliance with anti-malarial combination therapy among children in Senegal.
Carlotti, MP; Lalou, R; Le Hesran, JY; Moulin, P; Sarrassat, S; Souares, A, 2009
)
0.35
" We determined the association between amodiaquine dosage by body weight and mild adverse events (AEs) and investigated whether alternative age-based regimens could improve dosing accuracy and tolerability, using data from two trials of IPTc in Senegal, one in which AQ dose was determined by age and the other in which it was determined by weight category."( Amodiaquine dosage and tolerability for intermittent preventive treatment to prevent malaria in children.
Ba, EH; Cairns, M; Cames, C; Cisse, B; Gaye, O; Greenwood, BM; Milligan, PJ; Simondon, K; Sokhna, C; Trape, JF, 2010
)
0.36
" The use of sulphadoxine-pyrimethamine (SP) for intermittent preventive treatment of malaria during pregnancy was adopted when proof of its superiority to weekly prophylactic dosing with either chloroquine or pyrimethamine became evident from studies in different malaria endemic countries."( Scaling up of intermittent preventive treatment of malaria in pregnancy using sulphadoxine-pyrimethamine: prospects and challenges.
Agomo, CO; Oyibo, WA, 2011
)
0.37
" We discuss optimal dosing for ABCs and their likely protection against several sexually transmitted and reproductive tract infections."( Intermittent preventive treatment of malaria in pregnancy: at the crossroads of public health policy.
Chandramohan, D; Chico, RM, 2011
)
0.37
" Because of concerns about the complex dosing schedule, we assessed patient adherence to AL 2 years after routine implementation."( Adherence to treatment with artemether-lumefantrine for uncomplicated malaria in rural Malawi.
Ali, D; Filler, SJ; Jafali, J; Kachur, SP; Luka, M; Mace, KE; Mathanga, DP; Mwandama, D; Sande, J; Skarbinski, J, 2011
)
0.37
" There was significant association between gravidity and SP dosage taken (Pearson χ2 = 18."( The effectiveness and perception of the use of sulphadoxine-pyrimethamine in intermittent preventive treatment of malaria in pregnancy programme in Offinso district of Ashanti region, Ghana.
Browne, E; Lawson, B; Tutu, EO, 2011
)
0.37
" While SP was well known and attitudes towards IPTp were positive, health workers were often not informed of up-to-date dosing schedules, limiting coverage."( Systemic constraints continue to limit coverage of intermittent preventive treatment for malaria in pregnancy in southeast Tanzania.
Ba-Break, MM; Graham, KJ, 2013
)
0.39
"To maximize IPTp coverage, sufficient and consistent supplies of SP to both public and private health facilities are a necessity, combined with effective communication of revised dosing schedules."( Systemic constraints continue to limit coverage of intermittent preventive treatment for malaria in pregnancy in southeast Tanzania.
Ba-Break, MM; Graham, KJ, 2013
)
0.39
" However, the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs."( Protective efficacy and safety of three antimalarial regimens for the prevention of malaria in young Ugandan children: a randomized controlled trial.
Achan, J; Aweeka, FT; Bigira, V; Clark, TD; Dorsey, G; Havlir, DV; Huang, L; Kamya, MR; Kapisi, J; Kinara, S; Muhindo, MK; Mwangwa, F; Osterbauer, B; Rosenthal, PJ, 2014
)
0.4
" With this, one of the focuses of the pharmaceutical research scientist involves investigating possible metastable forms of a given drug to be incorporated into solid dosage forms."( Amorphous Sulfadoxine: A Physical Stability and Crystallization Kinetics Study.
Aucamp, M; Liebenberg, W; Milne, M, 2016
)
0.43
"While clinically relevant differences in SP disposition between trimesters were not seen, increased clearance with pregnancy and the increasing volume of distribution in the central compartment with gestational age lend support to the revised World Health Organization guidelines advocating more frequent dosing of SP for IPTp."( Trimester-Specific Population Pharmacokinetics and Other Correlates of Variability in Sulphadoxine-Pyrimethamine Disposition Among Ugandan Pregnant Women.
Bisaso, KR; Byamugisha, J; Mukonzo, JK; Ntale, M; Obua, C; Odia, G; Odongo, CO; Ojara, FW, 2015
)
0.42
"IPTp-SP usage among pregnant women in Sekondi-Takoradi reduces malaria and its use for malaria prevention should be strengthened with proper dosage completion and coverage."( Prevalence of intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) use during pregnancy and other associated factors in Sekondi-Takoradi, Ghana.
Acquah, S; Afoakwah, R; Boampong, JN; Iriemenam, NC; Nwaefuna, E; Onyeabor, OS; Orish, VN; Sanyaolu, AO, 2015
)
0.42
" We sought to determine whether increased dosage of SP is still associated with a reduced risk of low birth weight (LBW) in an area where malaria transmission is low."( Dosage of Sulfadoxine-Pyrimethamine and Risk of Low Birth Weight in a Cohort of Zambian Pregnant Women in a Low Malaria Prevalence Region.
Chi, BH; Kumwenda, A; Smid, M; Stoner, MC; Stringer, E; Stringer, JS; Vwalika, B, 2017
)
0.46
" falciparum found in pregnant women and the general population (GP) from Nanoro, Burkina Faso and the association of IPTp-SP dosing and other variables with mutations was studied."( Increase in the prevalence of mutations associated with sulfadoxine-pyrimethamine resistance in Plasmodium falciparum isolates collected from early to late pregnancy in Nanoro, Burkina Faso.
d'Alessandro, U; de Jong, MD; Derra, K; Geskus, RB; Lompo, P; Mens, PF; Ruizendaal, E; Schallig, HDFH; Scott, S; Tahita, MC; Tinto, H; Traore-Coulibaly, M; Versteeg, I, 2017
)
0.46
" An increase in mutation prevalence due to IPTp-SP dosing could not be confirmed."( Increase in the prevalence of mutations associated with sulfadoxine-pyrimethamine resistance in Plasmodium falciparum isolates collected from early to late pregnancy in Nanoro, Burkina Faso.
d'Alessandro, U; de Jong, MD; Derra, K; Geskus, RB; Lompo, P; Mens, PF; Ruizendaal, E; Schallig, HDFH; Scott, S; Tahita, MC; Tinto, H; Traore-Coulibaly, M; Versteeg, I, 2017
)
0.46
" This may soon change to recommending artemisinin-based combination therapies (standard duration of dosing = 3 days)."( Animal Embryotoxicity Studies of Key Non-Artemisinin Antimalarials and Use in Women in the First Trimester.
Clark, RL, 2017
)
0.46
"Despite extensive use and accumulated evidence of safety, there have been few pharmacokinetic studies from which appropriate chloroquine (CQ) dosing regimens could be developed specifically for pregnant women."( Optimal antimalarial dose regimens for chloroquine in pregnancy based on population pharmacokinetic modelling.
Baiwog, F; Davis, TME; Ilett, KF; Karunajeewa, HA; Kose, K; Mueller, I; Page-Sharp, M; Rogerson, SJ; Salman, S; Siba, PM, 2017
)
0.46
" Suboptimal dosing in children may lead to treatment failure and increased resistance."( Population Pharmacokinetic Properties of Sulfadoxine and Pyrimethamine: a Pooled Analysis To Inform Optimal Dosing in African Children with Uncomplicated Malaria.
Allen, EN; Barnes, KI; Bell, DJ; de Kock, M; Denti, P; Djimde, AA; Tarning, J; Tekete, MM; Ward, SA; Workman, L, 2018
)
0.48
" Future studies are needed to better understand the biological mechanisms of in utero drug exposure on drug metabolism and how this may affect the dosing of antimalarial drugs for treatment and prevention during infancy."( Dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria during pregnancy and risk of malaria in early childhood: A randomized controlled trial.
Aweeka, F; Beeson, J; Charlebois, ED; Clark, TD; Dorsey, G; Drakeley, C; Feeney, ME; Greenhouse, B; Havlir, DV; Jagannathan, P; Kakuru, A; Kamya, MR; Muhindo, MK; Nakalembe, M; Nankya, F; Natureeba, P; Okiring, J; Olwoch, P; Opira, B; Prahl, M; Reiling, L; Rodriguez-Barraquer, I; Ssewanyana, I; Tetteh, K; Wallender, E, 2018
)
0.48
" The adjusted dosing history for each individual was identified as the one with the lowest difference between observed and individual predicted concentrations estimated by the two PK models for all the possible adherence schemes."( Adherence to intermittent preventive treatment for malaria in Papua New Guinean infants: A pharmacological study alongside the randomized controlled trial.
Csajka, C; Décosterd, L; Genton, B; Guidi, M; Mueller, I; Schneider, M; Senn, N; Sottas, O; Thieffry, B, 2019
)
0.51
" We did a random-effects meta-analysis (clinical studies) or multivariate log-binomial regression (surveys) to obtain summarised dose-response data (relative risk reduction [RRR]) and multivariate meta-regression to explore the modifying effects of sulfadoxine-pyrimethamine resistance (as indicated by Ala437Gly, Lys540Glu, and Ala581Gly substitutions in the dhps gene)."( Effect of Plasmodium falciparum sulfadoxine-pyrimethamine resistance on the effectiveness of intermittent preventive therapy for malaria in pregnancy in Africa: a systematic review and meta-analysis.
Desai, M; Gutman, J; Hopkins Sibley, C; Kayentao, K; Khairallah, C; Koshy, G; Larsen, DA; Meshnick, SR; Okell, LC; Rogerson, SJ; Roper, C; Slaughter, DEC; Taylor, SM; Ter Kuile, FO; van Eijk, AM, 2019
)
0.51
" Interviews focused on perception of purpose of ANC pharmaceuticals (particularly iron supplements, sulfadoxine-pyrimethamine as intermittent prevention of malaria and antiretroviral therapy for HIV), beliefs regarding efficacy and risk, and understanding of dosage and regimen."( "They Merely Prescribe and I Merely Swallow": Perceptions of Antenatal Pharmaceuticals and Nutritional Supplements Among Pregnant Women in Bamako, Mali.
Doumbia, SO; Hurley, EA; Searle, AR; Winch, PJ, 2020
)
0.56
" Communication that positions pharmaceuticals as beneficial to mother and child, while presenting understandable information about purpose, dosing and potential side effects can promote uptake of multi-drug regimens and ANC services in general."( "They Merely Prescribe and I Merely Swallow": Perceptions of Antenatal Pharmaceuticals and Nutritional Supplements Among Pregnant Women in Bamako, Mali.
Doumbia, SO; Hurley, EA; Searle, AR; Winch, PJ, 2020
)
0.56
" Also, three or more dosing was associated (p < 0."( Coverage and effectiveness of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP) on adverse pregnancy outcomes in the Mount Cameroon area, South West Cameroon.
Achidi, EA; Anchang-Kimbi, JK; Apinjoh, TO; Dionne-Odom, J; Kalaji, LN; Mbacham, HF; Ngole Sumbele, IU; Tita, ATN; Wepnje, GB, 2020
)
0.56
" Mediation analyses showed sulfadoxine-pyrimethamine conferred a greater non-malarial effect than did dihydroartemisinin-piperaquine (mean difference 87 g, 95% CI 43 to 131), whereas dihydroartemisinin-piperaquine conferred a slightly larger antimalarial effect than did sulfadoxine-pyrimethamine (8 g, -9 to 26), although more frequent dosing increased the antimalarial effect (31 g, 3 to 60)."( Overall, anti-malarial, and non-malarial effect of intermittent preventive treatment during pregnancy with sulfadoxine-pyrimethamine on birthweight: a mediation analysis.
Chico, RM; Desai, M; Dorsey, G; Glymour, MM; Gosling, R; Gutman, J; Kajubi, R; Kakuru, A; Kamya, MR; Kuile, FOT; L'Ianziva, A; Rerolle, F; Roh, ME; Shiboski, S, 2020
)
0.56
" We assessed the different SP dosage regimen available under the new policy to determine the dose at which women obtained optimal protection against anaemia during pregnancy."( Intermittent preventive treatment comparing two versus three doses of sulphadoxine pyrimethamine (IPTp-SP) in the prevention of anaemia in pregnancy in Ghana: A cross-sectional study.
Agyeman, YN; Annor, RB; Newton, S; Owusu-Dabo, E, 2021
)
0.62
" This study shows that a successful implementation of the IPTp strategy can be achieved by improving access to prenatal care at community health facilities, and strengthening patient-provider communication to ensure adequate knowledge on dosing of IPTp-SP and the benefits to mother and child."( Determinants of intermittent preventive treatment with sulfadoxine-pyrimethamine in pregnant women (IPTp-SP) in Mali, a household survey.
Beebe, M; Doumbia, S; Sangho, O; Tounkara, M; Whiting-Collins, LJ; Winch, PJ, 2021
)
0.62
" We will also assess toxicity from cumulative DP dosing and the development of resistance."( Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-contro
Akun, P; Galileya, LT; Idro, R; Kalibbala, D; Nambatya, W; Nkosi-Gondwe, T; Opoka, R; Phiri, K; Robberstad, B; Rujumba, J; Ssenkusu, J; TerKuile, F, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (19)

Assay IDTitleYearJournalArticle
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,520)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990192 (12.63)18.7374
1990's119 (7.83)18.2507
2000's584 (38.42)29.6817
2010's503 (33.09)24.3611
2020's122 (8.03)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials440 (27.03%)5.53%
Reviews101 (6.20%)6.00%
Case Studies112 (6.88%)4.05%
Observational7 (0.43%)0.25%
Other968 (59.46%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (123)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Pharmacokinetics of Sulfadoxine-pyrimethamine Plus Amodiaquine When Used for Malaria Intermittent Preventive Treatment in Children [NCT01328990]Phase 1/Phase 2150 participants (Actual)Interventional2011-04-30Completed
Intermittent Preventive Treatment With Azithromycin-containing Regimens for the Prevention of Malarial Infections and Anaemia and the Control of Sexually Transmitted Infections in Pregnant Women in Papua New Guinea [NCT01136850]Phase 32,793 participants (Actual)Interventional2009-11-30Completed
Efficacy and Safety of Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Malaria Control Centers in Nangarhar, Kunar, Thakhar and Faryab Provinces of Afghanistan [NCT01115439]100 participants (Actual)Observational2010-03-31Completed
A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients [NCT02527005]Phase 1140 participants (Actual)Interventional2015-09-30Completed
Safety and Tolerability of Bi-monthly Intermittent Preventive Treatment With Mefloquine-Artesunate or Sulfadoxine-Pyrimethamine Plus Amodiaquine for Prevention of Malaria and Related Complications in Patients With Sickle Cell Anaemia. [NCT01319448]Phase 1/Phase 2270 participants (Actual)Interventional2011-09-30Completed
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants [NCT02793622]Phase 3782 participants (Actual)Interventional2016-09-30Completed
A Four-arm Trial Comparing Artemether-lumefantrine With or Without Single-dose Primaquine and Sulphadoxine-pyrimethamine/Amodiaquine With or Without Single-dose Tafenoquine to Reduce P. Falciparum Transmission in Mali [NCT05081089]Phase 280 participants (Actual)Interventional2021-10-12Completed
A Comparative Study of Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients [NCT02524444]Phase 1142 participants (Actual)Interventional2015-09-30Completed
Effects of Metronidazole Plus Intermittent Preventive Treatment of Malaria in Pregnancy on Birth Outcomes: a Randomised Controlled Trial in Zambia [NCT04189744]Phase 35,436 participants (Actual)Interventional2019-12-15Completed
A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children [NCT02211729]Phase 322,090 participants (Actual)Interventional2014-05-31Completed
Clinical Trial to Evaluate Efficacy and Safety of Sulfadoxine/Pyrimethamine-Amodiaquine and Dihydroartemsinin-Piperaquine Plus Ivermectin Administered Monthly as Intermittent Preventive Treatment in School-aged Children in Burkina Faso [NCT05946642]Phase 313,000 participants (Anticipated)Interventional2023-07-15Recruiting
MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention [NCT05085340]45,000 participants (Anticipated)Observational2022-02-14Recruiting
Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda [NCT04336189]Phase 32,757 participants (Anticipated)Interventional2020-12-28Recruiting
Safety and Feasibility of a Malaria Transmission Model in Semi-immune Kenyan Adults Using Plasmodium Falciparum Sporozoites [NCT04280692]Phase 1/Phase 244 participants (Actual)Interventional2022-08-22Active, not recruiting
Lungwena Antenatal Intervention Study. A Single-centre Intervention Trial in Rural Malawi, Testing Maternal and Infant Health Effects of Presumptive Intermittent Treatment of Pregnant Women With Sulfadoxine-pyrimethamine and Azithromycin [NCT00131235]Phase 31,320 participants (Actual)Interventional2003-12-31Active, not recruiting
Randomized Controlled Trial of Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Prophylaxis Against Malaria in Pregnancy (IPT) [NCT03944317]168 participants (Anticipated)Interventional2019-06-01Not yet recruiting
Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition [NCT06002438]400 participants (Anticipated)Interventional2023-10-09Recruiting
Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda [NCT01184911]Phase 40 participants (Actual)Interventional2010-10-31Withdrawn(stopped due to Research plan changed; no longer conducting clinical trial.)
A Randomized Controlled Trial of Monthly Dihydroartemisinin-piperaquine Versus Monthly Sulfadoxine-pyrimethamine Versus Daily Trimethoprim-sulfamethoxazole Versus No Therapy for the Prevention of Malaria [NCT00948896]Phase 3600 participants (Actual)Interventional2010-06-30Completed
Effectiveness of Seasonal Malaria Chemoprevention in Koulikoro, Mali [NCT04149106]Phase 34,556 participants (Anticipated)Interventional2019-07-01Active, not recruiting
'Controlled Human Malaria Infection Study to Assess Gametocytaemia and Mosquito Transmissibility in Participants Challenged With Plasmodium Falciparum by Sporozoite Challenge to Establish a Model for the Evaluation of Transmission-blocking Interventions' [NCT02836002]Phase 1/Phase 229 participants (Actual)Interventional2016-06-30Completed
Evaluation of the Safety and Effectiveness of EPI-linked Malaria Intermittent Chemotherapy and Iron Supplementation [NCT00857077]2,485 participants (Actual)Interventional2000-09-30Completed
Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission: Phase 2 Comparing Drug Regimens [NCT05980156]Phase 4646 participants (Actual)Interventional2023-02-13Completed
Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes [NCT03079388]1,489 participants (Actual)Interventional2017-02-27Completed
Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy [NCT00811421]5,820 participants (Actual)Interventional2009-09-30Completed
Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Cameroon: The Plus Project [NCT05889052]2,080 participants (Anticipated)Observational2023-07-19Recruiting
Intermittent Preventive Treatment in Pregnancy With Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine to Prevent Malaria Infection and Reduce Adverse Pregnancy Outcomes in Papua New Guinea - a Randomised Controlled Trial [NCT05426434]Phase 31,172 participants (Anticipated)Interventional2022-08-31Recruiting
IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda [NCT00852371]Phase 3760 participants (Actual)Interventional2008-02-29Completed
Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Côte d'Ivoire: The Plus Project [NCT05856357]1,568 participants (Anticipated)Observational2023-08-11Recruiting
Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine Versus Weekly Chloroquine Prophylaxis During Pregnancy in Solomon Islands: a Randomized Controlled Trial [NCT00964691]Phase 42,504 participants (Anticipated)Interventional2009-08-31Terminated(stopped due to Low prevalence of malaria, high prevalence of reported allergy to sulphur drugs, high proportion of women not meeting the inclusion criterea.)
A Safety, Tolerability, Pharmacokinetic and Efficacy Study of Azithromycin Plus Piperaquine as Presumptive Treatment in Pregnant Papua New Guinean Women [NCT02575755]Phase 4150 participants (Anticipated)Interventional2012-10-31Recruiting
The Role of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria And Its Effects in Pregnancy [NCT00711906]Phase 3352 participants (Actual)Interventional2009-02-28Terminated(stopped due to Malaria prev. fell in the study area, so we cannot evaluate the primary endpoint)
A Phase 3, Open Label, Randomized, Comparative Study To Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa [NCT01103063]Phase 32,891 participants (Actual)Interventional2010-10-31Terminated(stopped due to See termination reason in detailed description.)
Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon [NCT00951106]0 participants Interventional1998-01-31Completed
[NCT00766662]0 participants Interventional2006-10-31Completed
Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan [NCT00959517]Phase 2588 participants (Actual)Interventional2001-07-31Completed
Short Course of Quinine Plus a Single Dose of Sulphadoxine-Pyrimethamine for Plasmodium Falciparum Malaria [NCT00167739]Phase 450 participants Interventional2003-04-30Completed
Efficacy of Sulphadoxine-pyrimethamine and Amodiaquine Alone or in Combination as Intermittent Preventive Treatment in Pregnancy in the Kassena-Nankana District of Ghana: a Randomized Controlled Trial [NCT00146783]Phase 2/Phase 33,642 participants (Actual)Interventional2004-06-30Completed
Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants [NCT00152204]Phase 313,000 participants (Anticipated)Interventional2005-03-31Active, not recruiting
To Evaluate the Efficacy of Chloroquine and SP for Acute Uncomplicated P. Falciparum and the Efficacy of Chloroquine for Acute Uncomplicated P. Vivax in the Timika Region of Papua, Indonesia. [NCT00157859]150 participants Interventional2004-04-30Completed
An Open-label Three Arm Trial of the Efficacy and Safety of Chlorproguanil / Dapsone (Lapdap) Compared With Chloroquine and Sulfadoxine / Pyrimethamine for the Treatment of Vivax Malaria in Pakistan and Afghanistan [NCT00158561]Phase 3750 participants Interventional2004-02-29Completed
An Open Study for a 2-year Period to Confirm the Safety and Immunogenicity of the Candidate Malaria Vaccine RTS,S/AS02A in Mozambican Children Aged 1 to 4 Years at the Time of First Vaccine Dose. [NCT00323622]Phase 21,737 participants (Actual)Interventional2005-04-30Completed
Open Label Study to Evaluate Combination Anti-malarial Therapy,in Terms of Efficacy, Prevalence of Gametocyte Carriage and Molecular Markers Associated With Sulfadoxine Pyrimethamine Resistance in Uncomplicated Plasmodium Falciparum [NCT00203801]700 participants Interventional2002-01-31Completed
Evaluation of the Public Health Impact and Cost Effectiveness of Seasonal Intermittent Preventive Treatment in Children in Senegal [NCT00712374]Phase 4100,000 participants (Anticipated)Interventional2008-09-30Enrolling by invitation
New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa. [NCT00730366]Phase 32,766 participants (Actual)Interventional2004-03-31Completed
Acceptability and Feasibility of IPTp With Dihydroartemisinin-piperaquine With or Without Azithromycin to Prevent Malaria, Sexually Transmitted and Reproductive Tract Infections in HIV-uninfected Pregnant Women (IMPROVE) in Kenya. [NCT04160026]Phase 41,600 participants (Actual)Interventional2019-11-11Completed
Efficacy, Safety, and Pharmacokinetics of Sulphadoxine-pyrimethamine-amodiaquine (SP-AQ), SP-AQ Plus Primaquine, Dihydroartemisinin-piperaquine (DP), DP Plus Methylene Blue for Preventing Transmission of P. Falciparum Gametocytes in Mali [NCT02831023]Phase 280 participants (Actual)Interventional2016-07-31Completed
A Longitudinal Study Assessing the Infectious Status and Immunity of Mothers and Their Children in Lambaréné, Including Intermittent Treatment of Children With Sulfadoxine-pyrimethamine for Malaria Control and Its Impact on Long-term Health [NCT00167843]Phase 41,189 participants Interventional2002-12-31Completed
Open Label Drug Study (With Single and Parallel Group Components) to Evaluate Combination Antimalarial Therapy for Efficacy, Gametocyte Carriage and Molecular Markers Associated With SP Resistance in Uncomplicated Plasmodium Falciparum Infections [NCT00203736]240 participants Interventional2003-01-31Completed
Open-Label, Randomised, Parallel Group in Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy (CAT), Artesunate and Sulfadoxine-Pyrimethamine Versus Sulfadoxine-Pyrimethamine Alone, in Terms of Therapeutic Efficacy, Prevalence of Gametocyte Carr [NCT00203814]280 participants Interventional2004-01-31Completed
Effect of Single-course Malaria Chemoprevention on Clearance of and Protection From Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Zambia [NCT06166498]Phase 3600 participants (Anticipated)Interventional2024-02-15Not yet recruiting
Drug Options for Intermittent Preventive Treatment for Malaria in Infants in an Area With High Resistance to Sulfadoxine/Pyrimethamine: an Evaluation of Short and Long-acting Antimalarial Drugs [NCT00158574]Phase 2/Phase 32,419 participants (Actual)Interventional2005-01-31Completed
Effect of Intermittent Preventive Treatment (IPTp) With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets, Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women [NCT00209781]1,028 participants Interventional2003-08-31Active, not recruiting
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania [NCT02909712]Phase 2201 participants (Actual)Interventional2016-09-30Completed
Presumptive Treatment With Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prophylaxis in Children With Sickle Cell Anemia [NCT00399074]Phase 3220 participants (Anticipated)Interventional2006-10-31Completed
Preventing Anemia in Children (6months-30months) in a Malaria Endemic Rural Area in Ghana - A Randomized Double Blind Study [NCT00301054]872 participants Interventional2005-06-30Completed
An Open-label in Vivo Drug Study to Evaluate Artesunate Plus Sulfadoxine-pyrimethamine (ASSP) Pharmacokinetics, Therapeutic Efficacy, Gametocyte Carriage and Birth Outcomes in Pregnant Women With Uncomplicated Falciparum Malaria [NCT00331708]3 participants (Actual)Interventional2006-04-30Terminated(stopped due to Lack of suitable participants)
Characterization of Novel Molecular Tools for the Epidemiological Surveillance of Antimalarial Drug Resistance in Mali [NCT00127998]1,011 participants Interventional2005-07-31Completed
The Effectiveness, Cost and Cost Effectiveness of Intermittent Preventive Treatment or Screening and Treatment of Malaria in Pregnancy Among Women Using Long Lasting Insecticide Treated Bed Net: a Randomised Controlled Trial. [NCT00432367]Phase 33,333 participants (Actual)Interventional2007-02-28Completed
A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy [NCT00131703]Phase 3900 participants Interventional2003-03-31Completed
The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children With Recrudescent Malaria in Guinea-Bissau [NCT00137553]Phase 460 participants Interventional2001-05-31Completed
Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné [NCT00453856]Phase 4139 participants (Anticipated)Interventional2007-03-31Terminated(stopped due to The study was terminated because of Early Treatment Failure in child.The justification for this decision are concerns about safety of children.)
Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study [NCT00460369]240 participants (Actual)Interventional2007-04-30Completed
A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana [NCT00119132]Phase 2/Phase 32,602 participants (Actual)Interventional2005-06-30Completed
A Randomised, Placebo Controlled Trial of Intermittent Preventative Treatment With Sulfadoxine-pyrimethamine in Gambian Multigravidae. [NCT00120809]Phase 33,000 participants Interventional2002-07-31Completed
A Randomised Non-Inferiority Trial of Sulfadoxine-Pyrimethamine Plus Artesunate Compared to Chloroquine for the Treatment of Vivax Malaria in Eastern Afghanistan. [NCT00486694]Phase 2190 participants (Actual)Interventional2004-03-31Completed
Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children [NCT00140361]Phase 4390 participants (Actual)Interventional2000-01-31Completed
Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance [NCT00140517]700 participants Interventional2002-10-31Completed
A Randomised Trial of the Efficacy and Safety of Four Drug Regimens When Used for Intermittent Preventive Treatment of Malaria in Senegalese Children [NCT00132548]Phase 32,200 participants Interventional2004-06-30Completed
Evaluating the Effectiveness and Cost-effectiveness of Integrating Mass Drug Administration for Helminth Control With Seasonal Malaria Chemoprevention in Ghanaian Children [NCT06182176]1,200 participants (Anticipated)Interventional2024-05-27Not yet recruiting
Effectiveness of Seasonal Malaria Chemoprevention in Nampula Province, Mozambique: Evaluated Using a Type Two Hybrid Implementation Science Observational Study [NCT05186363]Phase 43,156 participants (Actual)Interventional2022-01-08Active, not recruiting
Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan [NCT00330902]Phase 3104 participants (Actual)Interventional2004-01-31Completed
Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali [NCT00452907]Phase 4780 participants (Actual)Interventional2005-07-31Completed
Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management [NCT00623155]262 participants (Actual)Interventional2002-07-31Completed
Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine [NCT00509015]6,000 participants (Anticipated)Interventional2008-02-29Completed
Randomized Trial of Effectiveness and Acceptability of Three Alternative Regimens for Malaria Seasonal Intermittent Preventive Treatment in Senegal [NCT00529620]Phase 31,833 participants (Actual)Interventional2007-09-30Completed
Efficacy and Safety of Pediatric Immunization-linked Preventive Intermittent Treatment With Antimalarials in Decreasing Anemia and Malaria Morbidity in Rural Western Kenya [NCT00111163]1,516 participants Interventional2004-03-31Completed
A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda [NCT00118027]2,150 participants Interventional2003-05-31Completed
Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children [NCT00118807]Phase 31,800 participants Interventional2003-08-31Completed
Pilot Study of Pyrimethamine and Sulfadoxine (Fansidar) for the Treatment of Individuals With the Autoimmune Lymphoproliferative Syndrome (ALPS) [NCT00013689]Phase 18 participants Interventional2001-03-31Completed
The Efficacy and Cost-effectiveness of Malaria Prevention in Pregnancy in an Area of Low and Unstable Transmission in Kabale, Uganda: Use of Intermittent Preventive Treatment and Insecticide-treated Nets. [NCT00142207]Phase 34,775 participants (Actual)Interventional2004-01-31Completed
The in-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Individuals-a 28 Day Efficacy Trial Involving HIV+ and HIV- Adults. [NCT00144352]Phase 4540 participants Interventional2002-09-30Completed
The Effect of Folic Acid Supplementation on Efficacy of Sulfadoxine-pyrimethamine in Pregnant Women in Western Kenya [NCT00130065]Phase 4600 participants Interventional2003-11-30Completed
IPTp With Dihydroartemisinin-piperaquine and Azithromycin for Malaria, Sexually Transmitted and Reproductive Tract Infections in Pregnancy in High Sulphadoxine-pyrimethamine Resistance Areas in Kenya, Malawi and Tanzania [NCT03208179]Phase 34,680 participants (Actual)Interventional2018-03-29Completed
The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children [NCT00209794]Phase 1/Phase 21,498 participants Interventional2002-09-30Active, not recruiting
A Phase II/III, Randomized, Comparative Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in India [NCT00074841]Phase 2/Phase 3230 participants (Actual)Interventional2003-09-30Completed
Chemoprophylaxis With Sulfadoxine-pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years [NCT00131716]Phase 31,200 participants (Actual)Interventional2003-05-31Completed
Influence of HIV Infection on the Effectiveness of Malaria Prevention During Pregnancy, With Emphasis on the Effect of Chloroquine on HIV Viral Load Among Pregnant Women in Uganda [NCT00132535]2,548 participants Interventional2003-08-31Completed
An Open Randomised Trial of the Efficacy of Sulfadoxine-Pyrimethamine (SP), Amodiaquine + SP (AQ-SP), AQ + Artesunate (AQ-Art), Chlorproguanil-Dapsone + Art (CD-Art), and Lumefantrine-Artemether (LA) for Uncomplicated Malaria in Malawi [NCT00164710]Phase 4365 participants Interventional2005-04-30Completed
A Phase 2/3, Randomized, Comparative, Double Blind Trial Of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia [NCT00084240]Phase 2/Phase 332 participants (Actual)Interventional2004-03-31Terminated(stopped due to See Detailed Description)
Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi [NCT06083688]Phase 41,000 participants (Anticipated)Interventional2024-10-31Not yet recruiting
Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines [NCT00229775]560 participants (Actual)Interventional2003-07-31Completed
Age of Exposure and Immunity to Malaria in Infants [NCT00231452]349 participants (Actual)Interventional2005-09-30Completed
Community Acceptability and Cost-effectiveness of Two Drug Distribution Methods for Home Based Management of Fevr in Kayunga District, Uganda [NCT00259142]1,314 participants (Anticipated)Interventional2005-11-30Terminated(stopped due to Study never started)
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia [NCT00270530]Phase 4454 participants Interventional2002-11-30Completed
Intermittent Preventive Treatment During Pregnancy in Benin: a Randomized, Open, and Equivalent Trial Comparing Sulfadoxine-Pyrimethamine With Mefloquine [NCT00274235]Phase 31,600 participants (Anticipated)Interventional2005-07-31Completed
Intermittent Preventive Treatment (IPTi) for the Prevention of Malaria and Anaemia in PNG Infants [NCT00285662]1,100 participants (Anticipated)Interventional2006-06-30Completed
A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy [NCT00287300]141 participants Interventional2003-09-30Completed
Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial [NCT00289250]Phase 3360 participants Interventional2001-05-31Completed
Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia [NCT00304980]3,000 participants Interventional2003-03-31Terminated
An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria [NCT01636895]Phase 4600 participants (Anticipated)Interventional2011-01-31Recruiting
An Individually Randomised Trial of Seasonal Malaria Chemoprevention Versus a Long-acting Artemisinin Combination Therapy for the Prevention of Malaria and Anaemia in Children Living in an Area of Extended Seasonal Transmission in Ghana. [NCT01651416]Phase 42,400 participants (Actual)Interventional2012-07-31Completed
Intermittent Screening and Treatment (IST) or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya: a Randomized Controlled Trial [NCT01669941]Phase 41,546 participants (Actual)Interventional2012-08-31Completed
Efficacy and Safety of Artesunate+Sulphadoxine-Pyrimethamine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Malaria Control Center Asadabad in Kunar Province of Afghanistan [NCT01707199]83 participants (Actual)Interventional2012-10-31Completed
A Randomized, Controlled Clinical Trial of Chloroquine as Chemoprophylaxis Versus Intermittent Preventive Therapy to Prevent Malaria in Pregnancy in Malawi [NCT01443130]Phase 3900 participants (Actual)Interventional2012-02-29Completed
Comparative Study of Efficacy of Two Antifolates Prophylactic Strategies Against Malaria in HIV Positive Pregnant Women (MACOMBA Study) [NCT01746199]Phase 3193 participants (Actual)Interventional2013-12-31Completed
Seasonal Malaria Chemoprevention in Burkina Faso : Chemoprevention Efficacy Study [NCT05478954]Phase 4800 participants (Actual)Interventional2022-07-15Active, not recruiting
Controlled Human Malaria Infection Study to Assess Gametocytemia and Mosquito Transmissibility in Participants Challenged With Plasmodium Falciparum by Sporozoite or Blood Stage Challenge to Establish a Model for the Evaluation of Transmission-blocking In [NCT03454048]24 participants (Actual)Interventional2018-05-07Completed
An Open-label in Vivo Drug Study to Evaluate the Pharmacokinetics, Therapeutic Efficacy, Gametocyte Carriage and Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment (SP IPT) in Pregnant Women [NCT00380146]31 participants (Actual)Interventional2006-09-30Completed
Monitoring of Markers of Sulfadoxine-pyrimethamine (SP) Resistance in the Implementation Countries of TIPTOP Project [NCT03998839]7,200 participants (Actual)Observational2018-03-05Completed
Comparison of IST Using Ultra-sensitive Malaria Rapid Diagnostic Test and Pyronaridine - Artesunate - PYRAMAX®) to Standard IPT Sulfadoxine-pyrimethamine to Prevent Malaria in Pregnant Women Living in Endemic Areas [NCT04783051]Phase 3250 participants (Actual)Interventional2021-05-06Completed
Efficacy of Sulphadoxine/Pyrimethamine and Chlorproguanil/Dapsone in 6-59 Month Old Children With Uncomplicated Malaria and in 2-10 Month Old Asymptomatic Infants. [NCT00361114]Phase 3112 participants (Actual)Interventional2006-07-31Terminated(stopped due to SP arms were stopped due to high levels of treatment failure.CD not available.)
Efficacy and Safety of Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine Regimens Delivered Through Intermittent Preventive Treatment in Schoolchildren of Democratic Republic of Congo: A Randomised Control Trial [NCT01722539]Phase 3616 participants (Actual)Interventional2012-11-30Completed
Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Kolokani Circle, Koulikoro Region, Mali, August-November 2016: Interventional Matched-pair Clustered Cohort [NCT03035305]36,717 participants (Actual)Interventional2016-08-31Completed
Feasibility and Effectiveness of Delivering Mass Drug Administration for Helminths Through the Seasonal Malaria Chemoprevention (SMC) Platform in a West African Paediatric Population [NCT05354258]600 participants (Anticipated)Interventional2022-06-16Active, not recruiting
A Prospective Randomized Open-Label Study on the Efficacy and Safety of Intermittent Preventive Treatment in Pregnancy (IPTp) With Dihydroartemisinin-Piperaquine (DP) Versus IPTp With Sulfadoxine-Pyrimethamine (SP) in Malawi [NCT03009526]Phase 3602 participants (Actual)Interventional2017-01-17Completed
Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants (PROMOTE Birth Cohort 1) [NCT02163447]Phase 3300 participants (Actual)Interventional2014-06-23Completed
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda [NCT00372632]Phase 41,717 participants (Actual)Interventional2005-12-31Completed
Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition [NCT02351687]1,499 participants (Actual)Interventional2014-04-30Completed
Improving Cognition and Gestational Duration With Targeted Nutrition [NCT05949190]1,600 participants (Anticipated)Interventional2023-08-18Recruiting
Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine in University College Hospital [NCT03599596]Phase 1136 participants (Anticipated)Interventional2018-09-01Not yet recruiting
Effectiveness, Feasibility and Acceptability of Seasonal Malaria Chemoprevention in Aweil South County in Northern Bahr Eel Ghazal, South Sudan: A Type 2 Hybrid Effectiveness-implementation Study Using a Convergent Mixed-methods Approach [NCT05471544]Phase 33,575 participants (Anticipated)Interventional2022-07-18Active, not recruiting
A Hybrid Effectiveness-implementation Study to Assess the Effectiveness and Chemoprevention Efficacy of Implementing Seasonal Malaria Chemoprevention in Five Districts in Karamoja Region, Uganda [NCT05323721]Phase 46,805 participants (Actual)Interventional2022-06-01Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00323622 (10) [back to overview]Time to First or Only Clinical Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Primary Case Definition
NCT00323622 (10) [back to overview]Number of Subjects With Serious Adverse Events (SAEs)
NCT00323622 (10) [back to overview]Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 3
NCT00323622 (10) [back to overview]Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 2
NCT00323622 (10) [back to overview]Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 1
NCT00323622 (10) [back to overview]Number of Subjects With Anemia.
NCT00323622 (10) [back to overview]Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) Parasitemia
NCT00323622 (10) [back to overview]Number of Primary Case Definition Clinical Episodes of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI)
NCT00323622 (10) [back to overview]Anti-hepatitis B (HBs) Antibody Concentrations.
NCT00323622 (10) [back to overview]Anti-circumsporozoite Protein (CS) Antibody Concentrations.
NCT00948896 (4) [back to overview]Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants
NCT00948896 (4) [back to overview]Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants
NCT00948896 (4) [back to overview]Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs
NCT00948896 (4) [back to overview]Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk
NCT01103063 (30) [back to overview]Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
NCT01103063 (30) [back to overview]Sexually Transmitted Infection (STI) Episodes Per Participant
NCT01103063 (30) [back to overview]Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
NCT01103063 (30) [back to overview]Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
NCT01103063 (30) [back to overview]Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population
NCT01103063 (30) [back to overview]Birth Weight of Live Borne Neonate
NCT01103063 (30) [back to overview]Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.
NCT01103063 (30) [back to overview]Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
NCT01103063 (30) [back to overview]Percentage of Neonates With Congenital Abnormalities at Birth
NCT01103063 (30) [back to overview]Percentage of Neonates With LBW (<2500 g) in ITT Population
NCT01103063 (30) [back to overview]Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
NCT01103063 (30) [back to overview]Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
NCT01103063 (30) [back to overview]Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
NCT01103063 (30) [back to overview]Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.
NCT01103063 (30) [back to overview]Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
NCT01103063 (30) [back to overview]Percentage of Participants With Cord Blood Parasitemia at Delivery
NCT01103063 (30) [back to overview]Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation
NCT01103063 (30) [back to overview]Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
NCT01103063 (30) [back to overview]Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
NCT01103063 (30) [back to overview]Percentage of Participants With Peripheral Parasitemia at Delivery
NCT01103063 (30) [back to overview]Percentage of Participants With Placental Malaria at Delivery Based on Histology
NCT01103063 (30) [back to overview]Percentage of Participants With Placental Parasitemia at Delivery
NCT01103063 (30) [back to overview]Percentage of Participants With Pre-eclampsia From Week 20 to Delivery
NCT01103063 (30) [back to overview]Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
NCT01103063 (30) [back to overview]Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
NCT01103063 (30) [back to overview]Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population
NCT01103063 (30) [back to overview]Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
NCT01103063 (30) [back to overview]Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation
NCT01103063 (30) [back to overview]Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
NCT01103063 (30) [back to overview]Percentage of Perinatal or Neonatal Deaths
NCT01443130 (14) [back to overview]Incidence of Infection in the Fetal Circulation
NCT01443130 (14) [back to overview]Incidence of Clinical Malaria, All Species
NCT01443130 (14) [back to overview]Incidence of Active Placental Malaria Infection
NCT01443130 (14) [back to overview]Incidence of Intrauterine Growth Restriction (IUGR)
NCT01443130 (14) [back to overview]Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)
NCT01443130 (14) [back to overview]Incidence of Malaria Infection, All Species.
NCT01443130 (14) [back to overview]Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)
NCT01443130 (14) [back to overview]Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)
NCT01443130 (14) [back to overview]Incidence of Miscarriage
NCT01443130 (14) [back to overview]Incidence of Placental Malaria by Placental Impression Smear
NCT01443130 (14) [back to overview]Incidence of Placental Malaria Infection Based on Histology
NCT01443130 (14) [back to overview]Incidence of Preterm Delivery
NCT01443130 (14) [back to overview]Incidence of Stillbirth
NCT01443130 (14) [back to overview]Infant Mortality Rate to 14 Weeks of Age
NCT02163447 (14) [back to overview]Incidence of Malaria in Infants
NCT02163447 (14) [back to overview]Incidence of Complicated Malaria in Infants
NCT02163447 (14) [back to overview]Incidence of Hospital Admissions in Infants
NCT02163447 (14) [back to overview]Incidence of Malaria in Infants
NCT02163447 (14) [back to overview]Incidence of Malaria in Pregnant Women
NCT02163447 (14) [back to overview]Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery
NCT02163447 (14) [back to overview]Prevalence of Anemia in Pregnant Women
NCT02163447 (14) [back to overview]Prevalence of Gametocytemia in Infants
NCT02163447 (14) [back to overview]Prevalence of Gametocytemia in Pregnant Women
NCT02163447 (14) [back to overview]Prevalence of Parasitemia at the Time of Monthly Routine Visits During Pregnancy
NCT02163447 (14) [back to overview]Prevalence of Parasitemia in Infants
NCT02163447 (14) [back to overview]Prevalence of Placental Malaria
NCT02163447 (14) [back to overview]Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP
NCT02163447 (14) [back to overview]Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery
NCT02793622 (14) [back to overview]Incidence of Malaria in Infants
NCT02793622 (14) [back to overview]Incidence of Hospital Admissions in Infants
NCT02793622 (14) [back to overview]Incidence of Complicated Malaria in Infants
NCT02793622 (14) [back to overview]Prevalence of Maternal Malaria
NCT02793622 (14) [back to overview]Prevalence of Placental Parasitemia
NCT02793622 (14) [back to overview]Prevalence of Placental Malaria by Histology
NCT02793622 (14) [back to overview]Prevalence of Asymptomatic Parasitemia in Pregnant Women
NCT02793622 (14) [back to overview]Prevalence of Asymptomatic Parasitemia in Infants
NCT02793622 (14) [back to overview]Prevalence of Anemia in Pregnant Women
NCT02793622 (14) [back to overview]Prevalence of Anemia in Infants
NCT02793622 (14) [back to overview]Number of Participants With Adverse Events
NCT02793622 (14) [back to overview]Number of Participants Who Deliver With a Composite Adverse Birth Outcome
NCT02793622 (14) [back to overview]Mean Gestational Age in Weeks at Birth
NCT02793622 (14) [back to overview]Infant Mortality Rate
NCT03454048 (8) [back to overview]AUC Gametocytes
NCT03454048 (8) [back to overview]Frequency of Adverse Events in the CHMI-trans Model
NCT03454048 (8) [back to overview]Gametocyte Commitment
NCT03454048 (8) [back to overview]Gametocyte Prevalence
NCT03454048 (8) [back to overview]Gametocyte Sex-ratio
NCT03454048 (8) [back to overview]Number of Participants Infectious for Mosquitoes Through DFA
NCT03454048 (8) [back to overview]Peak Density Gametocytes
NCT03454048 (8) [back to overview]Magnitude of Adverse Events in the CHMI-trans Model

Time to First or Only Clinical Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Primary Case Definition

Malaria infection by Plasmodium falciparum was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges. (NCT00323622)
Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

,
Interventionn/PYAR (Number)
RPFMI - PCD - M21-33 (N=650;645)RPFMI - PCD - M33-45 (N=638;629)
Cohort 1-Engerix-B/Prevnar-Hiberix Group0.3750.149
Cohort 1-RTS,S/AS02A Group0.3300.140

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Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. (NCT00323622)
Timeframe: Throughout the entire study period: from Month 21 to Month 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

InterventionSubjects (Number)
Cohort 1-RTS,S/AS02A <24M Group21
Cohort 1-RTS,S/AS02A ≥24M Group17
Cohort 2-RTS,S/AS02A <24M Group1
Cohort 2-RTS,S/AS02A ≥24M Group0
Cohort 1-Prevnar-Hiberix <24M Group24
Cohort 1-Engerix-B ≥24M Group29
Cohort 2-Prevnar- Hiberix <24M Group1
Cohort 2-Engerix-B ≥24M Group4

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Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 3

PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 3 was defined as the presence of P. falciparum asexual parasitaemia above 15000 per microliter (µL) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges. (NCT00323622)
Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

,
Interventionn/PYAR (Number)
RPFMI - SCD 3 - M21-33 (N=650;645)RPFMI - SCD 3 - M33-45 (N=638;629)
Cohort 1-Engerix-B/Prevnar-Hiberix Group0.3290.122
Cohort 1-RTS,S/AS02A Group0.2880.122

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Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 2

PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 2 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films in an unwell child brought for treatment with a history of fever (axillary temperature equal or above 37.5 degrees Celsius) within 24 hours or documented fever. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects, with groups pooled across age ranges. (NCT00323622)
Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

,
Interventionn/PYAR (Number)
RPFMI - SCD 2 - M21-33 (N=650;645)RPFMI - SCD 2 - M33-45 (N=638;629)
Cohort 1-Engerix-B/Prevnar-Hiberix Group0.6300.270
Cohort 1-RTS,S/AS02A Group0.5400.260

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Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 1

PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 1 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges. (NCT00323622)
Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

,
Interventionn/PYAR (Number)
RPFMI - SCD 1 - M21-33 (N=650;645)RPFMI - SCD 1 - M33-45 (N=638;629)
Cohort 1-Engerix-B/Prevnar-Hiberix Group0.4090.174
Cohort 1-RTS,S/AS02A Group0.3650.161

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Number of Subjects With Anemia.

"Anemia was indicated by a hematocrit level (HL) below (<) 25%. The numbers of subjects with HL below (<) and above or equal (≥) 25 %, and with missing HL results were tabulated. In the tabulation below, the number of subjects falling into the HL ≥25% category corresponds to the number of subjects with anemia as asked per outcome. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges." (NCT00323622)
Timeframe: At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

,
InterventionSubjects (Number)
HL <25%, Month 33 (N = 650, 645)HL ≥25%, Month 33 (N = 650, 645])Missing Results, Month 33 (N = 650;645)HL <25%, Month 45 (N = 638, 629)HL ≥25%, Month 45 (N = 638, 629)Missing Results, Month 45 (N = 638;629)
Cohort 1-Engerix-B/Prevnar-Hiberix Group259350054386
Cohort 1-RTS,S/AS02A Group258464054098

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Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) Parasitemia

Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges. (NCT00323622)
Timeframe: At Months 33 (M33) and 45 (M45) (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

,
InterventionSubjects (Number)
Subjects prevalent for parasitemia, M33[N=590,590]Subjects prevalent for parasitemia, M45[N=541,547]
Cohort 1-Engerix-B/Prevnar-Hiberix Group121101
Cohort 1-RTS,S/AS02A Group9366

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Number of Primary Case Definition Clinical Episodes of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI)

PFMI was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The number of PFMI episodes (EPFMI) per person-year (pyr) was tabulated, using as unit EPFMI episode per pyr. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges. (NCT00323622)
Timeframe: From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041

,
InterventionEPFMI episode per pyr (Number)
EPFMI - PCD - M21-33 (N=650;645)EPFMI - PCD - M33-45 (N=638;629)
Cohort 1-Engerix-B/Prevnar-Hiberix Group291100
Cohort 1-RTS,S/AS02A Group25299

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Anti-hepatitis B (HBs) Antibody Concentrations.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). Anti-HBs antibody concentration levels were measured in blood samples from Cohort 2 only. (NCT00323622)
Timeframe: At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

,,,
InterventionmIU/mL (Geometric Mean)
Month 33 [N = 33, 116, 34, 115]Month 45 [N = 35, 115, 32, 113]
Cohort 2-Engerix-B ≥24M Group67.499.4
Cohort 2-Prevnar- Hiberix <24M Group20.326.6
Cohort 2-RTS,S/AS02A <24M Group4008.63323.8
Cohort 2-RTS,S/AS02A ≥24M Group1842.51557.0

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Anti-circumsporozoite Protein (CS) Antibody Concentrations.

Concentrations for anti-CS antibodies are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 0.5 EL.U/mL. Subjects were pooled across age ranges for this outcome measure. (NCT00323622)
Timeframe: At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).

,,,
InterventionEL.U/mL (Geometric Mean)
Month 33 [N = 490, 487, 149, 149]Month 45 [N = 452, 447, 150, 145]
Cohort 1-Engerix-B/Prevnar-Hiberix GroupNANA
Cohort 1-RTS,S/AS02A Group10.18.9
Cohort 2-Engerix-B/Prevnar-Hiberix Group0.60.4
Cohort 2-RTS,S/AS02A Group16.215.4

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

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

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

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

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

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

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

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

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

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Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population

Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine26.16
Sulfadoxine + Pyrimethamine23.67

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Sexually Transmitted Infection (STI) Episodes Per Participant

Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results). (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age .

InterventionNumber of episodes (Least Squares Mean)
Azithromycin + Chloroquine0.14
Sulfadoxine + Pyrimethamine0.19

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Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae

This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics. (NCT01103063)
Timeframe: Visits 6 and 7

,
InterventionPercentage of participants (Number)
Visit 6 (N = 8 and 17 respectively)Visit 7 (N = 16 and 11 respectively)
Azithromycin + Chloroquine00
Sulfadoxine + Pyrimethamine11.760

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Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae

This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics. (NCT01103063)
Timeframe: Visits 6 and 7

,
InterventionPercentage of participants (Number)
Visit 6 (N = 8 and 17 respectively)Visit 7 (N = 16 and 11 respectively)
Azithromycin + Chloroquine00
Sulfadoxine + Pyrimethamine00

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Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population

LBW was defined as live birth weight <2500 g (up to and including 2499 g). (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of neonates (Number)
Azithromycin + Chloroquine4.72
Sulfadoxine + Pyrimethamine5.21

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Birth Weight of Live Borne Neonate

Birth weight of live borne neonates were calculated in grams. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age.

Interventiongrams (Least Squares Mean)
Azithromycin + Chloroquine3148.3
Sulfadoxine + Pyrimethamine3146.2

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Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.

Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted. (NCT01103063)
Timeframe: Baseline, at 36-38 weeks of gestation.

Interventiong/dL (Least Squares Mean)
Azithromycin + Chloroquine0.13
Sulfadoxine + Pyrimethamine0.27

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Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery

This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionNumber of episodes (Least Squares Mean)
Azithromycin + Chloroquine0.06
Sulfadoxine + Pyrimethamine0.13

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Percentage of Neonates With Congenital Abnormalities at Birth

Neonates with congenital abnormalities at birth were noted. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age.

InterventionPercentage of neonates (Number)
Azithromycin + Chloroquine2.19
Sulfadoxine + Pyrimethamine2.44

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Percentage of Neonates With LBW (<2500 g) in ITT Population

LBW was defined as live birth weight <2500 g (up to and including 2499 g). (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of neonates (Number)
Azithromycin + Chloroquine5.01
Sulfadoxine + Pyrimethamine5.72

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Percentage of Neonates With Ophthalmia Neonatorum at Birth Period

Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of neonates (Number)
Azithromycin + Chloroquine0.35
Sulfadoxine + Pyrimethamine0.17

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Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery

This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results). (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine5.74
Sulfadoxine + Pyrimethamine10.52

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Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery

Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery. (NCT01103063)
Timeframe: Up to approximately 40 weeks of gestational age

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine0.48
Sulfadoxine + Pyrimethamine1.25

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Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.

Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining. (NCT01103063)
Timeframe: At 36-38 weeks of gestation

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine8.58
Sulfadoxine + Pyrimethamine11.84

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Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation

Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis. (NCT01103063)
Timeframe: At 36-38 weeks of gestation

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine1.47
Sulfadoxine + Pyrimethamine0.63

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Percentage of Participants With Cord Blood Parasitemia at Delivery

This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine0.49
Sulfadoxine + Pyrimethamine0.75

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Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation

Anemia was defined as Hb <11 g/dL. (NCT01103063)
Timeframe: At 36-38 weeks of gestation.

InterventionPercentage of Participants (Number)
Azithromycin + Chloroquine50.57
Sulfadoxine + Pyrimethamine49.11

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Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation

Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis. (NCT01103063)
Timeframe: At 36-38 weeks of gestation

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine0.40
Sulfadoxine + Pyrimethamine1.64

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Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation

This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. (NCT01103063)
Timeframe: At 36-38 weeks of gestation

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine2.71
Sulfadoxine + Pyrimethamine4.38

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Percentage of Participants With Peripheral Parasitemia at Delivery

This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine6.05
Sulfadoxine + Pyrimethamine7.46

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Percentage of Participants With Placental Malaria at Delivery Based on Histology

Participants positive for placental malaria at delivery were evaluated based on placental histology. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine4.81
Sulfadoxine + Pyrimethamine5.73

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Percentage of Participants With Placental Parasitemia at Delivery

Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine5.30
Sulfadoxine + Pyrimethamine5.67

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Percentage of Participants With Pre-eclampsia From Week 20 to Delivery

Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection. (NCT01103063)
Timeframe: From Week 20 to approximately 40 weeks of gestational age

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine0.63
Sulfadoxine + Pyrimethamine1.04

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Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation

Severe maternal anemia was defined as Hb <8 g/dL. (NCT01103063)
Timeframe: At 36-38 weeks of gestation.

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine1.80
Sulfadoxine + Pyrimethamine2.00

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Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation

Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38. (NCT01103063)
Timeframe: Upto 36-38 weeks of gestation

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine12.32
Sulfadoxine + Pyrimethamine16.47

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Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population

Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age

InterventionPercentage of Participants (Number)
Azithromycin + Chloroquine10.38
Sulfadoxine + Pyrimethamine10.12

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Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation

Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. (NCT01103063)
Timeframe: Approximately 40 weeks of gestational age.

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine28.51
Sulfadoxine + Pyrimethamine26.51

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Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation

Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used. (NCT01103063)
Timeframe: At 36-38 weeks of gestation

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine0.93
Sulfadoxine + Pyrimethamine2.01

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Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation

Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test. (NCT01103063)
Timeframe: At 36-38 weeks of gestation

InterventionPercentage of participants (Number)
Azithromycin + Chloroquine8.24
Sulfadoxine + Pyrimethamine10.67

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Percentage of Perinatal or Neonatal Deaths

Percentage of perinatal or neonatal deaths were noted. (NCT01103063)
Timeframe: Day 28 after delivery.

InterventionPercentage of neonates (Number)
Azithromycin + Chloroquine2.19
Sulfadoxine + Pyrimethamine1.85

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Incidence of Infection in the Fetal Circulation

Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of participants (Number)
Maternal Chloroquine Prophylaxis1.95
Maternal Chloroquine IPT2.78
Maternal SP IPT0.80

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Incidence of Clinical Malaria, All Species

Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness. (NCT01443130)
Timeframe: Enrollment to delivery (approximately 12-36 weeks)

Interventionpercentage of participants (Number)
Maternal Chloroquine Prophylaxis0.67
Maternal Chloroquine IPT1.33
Maternal SP IPT3.00

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Incidence of Active Placental Malaria Infection

Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR). (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of participants (Number)
Maternal Chloroquine Prophylaxis3.09
Maternal Chloroquine IPT3.16
Maternal SP IPT4.74

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Incidence of Intrauterine Growth Restriction (IUGR)

Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of participants (Number)
Infant Chloroquine Prophylaxis16.54
Infant Chloroquine IPT18.01
Infant SP IPT20.80

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Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of infants (Number)
Infant Chloroquine Prophylaxis15.59
Infant Chloroquine IPT10.98
Infant SP IPT12.11

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Incidence of Malaria Infection, All Species.

Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects. (NCT01443130)
Timeframe: Enrollment to delivery (approximately 12-36 weeks)

Interventionpercentage of participants (Number)
Maternal Chloroquine Prophylaxis0.67
Maternal Chloroquine IPT1.67
Maternal SP IPT3.00

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Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL). (NCT01443130)
Timeframe: From enrollment until delivery, approximately 12-36 weeks

Interventionpercentage of maternal participants (Number)
Maternal Chloroquine Prophylaxis18.3
Maternal Chloroquine IPT23.7
Maternal SP IPT22.0

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Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl. (NCT01443130)
Timeframe: From enrollment until delivery, approximately 12-36 weeks

Interventionpercentage of maternal participants (Number)
Maternal Chloroquine Prophylaxis0.0
Maternal Chloroquine IPT0.3
Maternal SP IPT0.3

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Incidence of Miscarriage

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of pregnancies (Number)
Maternal Chloroquine Prophylaxis0.33
Maternal Chloroquine IPT0.67
Maternal SP IPT1.00

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Incidence of Placental Malaria by Placental Impression Smear

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of placentas (Number)
Maternal Chloroquine Prophylaxis0
Maternal Chloroquine IPT0
Maternal SP IPT0.40

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Incidence of Placental Malaria Infection Based on Histology

The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of pregnancies (Number)
Maternal Chloroquine Prophylaxis11.58
Maternal Chloroquine IPT15.42
Maternal SP IPT15.42

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Incidence of Preterm Delivery

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of deliveries (Number)
Maternal Chloroquine Prophylaxis8.46
Maternal Chloroquine IPT9.89
Maternal SP IPT6.84

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Incidence of Stillbirth

Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

Interventionpercentage of deliveries (Number)
Maternal Chloroquine Prophylaxis1.10
Maternal Chloroquine IPT0.37
Maternal SP IPT1.90

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Infant Mortality Rate to 14 Weeks of Age

Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery. (NCT01443130)
Timeframe: For 14 weeks after delivery.

Interventionpercentage of infants (Number)
Infant Chloroquine Prophylaxis2.22
Infant Chloroquine IPT3.65
Infant SP IPT3.09

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Incidence of Malaria in Infants

Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. (NCT02163447)
Timeframe: Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination

InterventionEvents per person years (Number)
3 Dose SP Pregnancy / 3 Monthly DP Infancy0.87
3 Dose DP Pregnancy / 3 Monthly DP Infancy0.88
3 Dose DP Pregnancy / Monthly DP Infancy0.83
Monthly DP Pregnancy / 3 Monthly DP Infancy1.24
Monthly DP Pregnancy / Monthly DP Infancy0.64

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Incidence of Complicated Malaria in Infants

Any treatment for malaria meeting criteria for severe malaria or danger signs (NCT02163447)
Timeframe: Birth up to 24 months of age or early study termination

InterventionEvents per person years (Number)
3 Dose SP Pregnancy / 3 Monthly DP Infancy0.022
3 Dose DP Pregnancy / 3 Monthly DP Infancy0.024
3 Dose DP Pregnancy / Monthly DP Infancy0.000
Monthly DP Pregnancy / 3 Monthly DP Infancy0.035
Monthly DP Pregnancy / Monthly DP Infancy0.000

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Incidence of Hospital Admissions in Infants

Admission to a hospital for pediatric inpatient care for any reason (NCT02163447)
Timeframe: Birth up to 24 months of age or early study termination

InterventionEvents per person years (Number)
3 Dose SP Pregnancy / 3 Monthly DP Infancy0.043
3 Dose DP Pregnancy / 3 Monthly DP Infancy0.036
3 Dose DP Pregnancy / Monthly DP Infancy0.089
Monthly DP Pregnancy / 3 Monthly DP Infancy0.082
Monthly DP Pregnancy / Monthly DP Infancy0.043

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Incidence of Malaria in Infants

Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. (NCT02163447)
Timeframe: Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age)

InterventionEvents per person years (Number)
3 Dose SP Pregnancy / 3 Monthly DP Infancy0.26
3 Dose DP Pregnancy / 3 Monthly DP Infancy0.30
3 Dose DP Pregnancy / Monthly DP Infancy0.00
Monthly DP Pregnancy / 3 Monthly DP Infancy0.43
Monthly DP Pregnancy / Monthly DP Infancy0.03

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Incidence of Malaria in Pregnant Women

Incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. (NCT02163447)
Timeframe: Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination

Interventionevents per person years (Number)
Mothers - 3 Dose SP0.95
Mothers - 3 Dose DP0.31
Mothers - Monthly DP0

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Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery

Congenital malformations, spontaneous abortion, LBW (<2500g), still birth, pre-term delivery (NCT02163447)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Mothers - 3 Dose SP19
Mothers - 3 Dose DP19
Mothers - Monthly DP9

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Prevalence of Anemia in Pregnant Women

Prevalence of routine hemoglobin measurements < 11 g/dL (NCT02163447)
Timeframe: After first dose of study drugs up to delivery or early termination

Interventionhemoglobin measurements taken every 12wk (Number)
Mothers - 3 Dose SP94
Mothers - 3 Dose DP72
Mothers - Monthly DP61

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Prevalence of Gametocytemia in Infants

Proportion of routine blood smears positive for gametocytes (NCT02163447)
Timeframe: Birth up to 24 months of age or early study termination

InterventionPositive blood smears (Number)
3 Dose SP Pregnancy / 3 Monthly DP Infancy7
3 Dose DP Pregnancy / 3 Monthly DP Infancy1
3 Dose DP Pregnancy / Monthly DP Infancy0
Monthly DP Pregnancy / 3 Monthly DP Infancy4
Monthly DP Pregnancy / Monthly DP Infancy0

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Prevalence of Gametocytemia in Pregnant Women

Proportion of urgent blood smears positive for gametocytes (NCT02163447)
Timeframe: Gestational age between 12-20 weeks (at study entry) up to delivery

InterventionPositive blood smears (Number)
Mothers - 3 Dose SP4
Mothers - 3 Dose DP1
Mothers - Monthly DP3

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Prevalence of Parasitemia at the Time of Monthly Routine Visits During Pregnancy

Detection of malaria parasites by LAMP during pregnancy (NCT02163447)
Timeframe: After first dose of study drug through delivery or early termination

InterventionPositive specimens (Number)
Mothers - 3 Dose SP206
Mothers - 3 Dose DP74
Mothers - Monthly DP26

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Prevalence of Parasitemia in Infants

Proportion of routine monthly samples positive for parasites by LAMP. Proportion of routine samples (LAMP or blood smears) positive for asexual parasites. (NCT02163447)
Timeframe: Birth up to 24 months of age or early study termination

InterventionPositive blood smears (Number)
3 Dose SP Pregnancy / 3 Monthly DP Infancy59
3 Dose DP Pregnancy / 3 Monthly DP Infancy25
3 Dose DP Pregnancy / Monthly DP Infancy7
Monthly DP Pregnancy / 3 Monthly DP Infancy52
Monthly DP Pregnancy / Monthly DP Infancy4

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Prevalence of Placental Malaria

Prevalence of placental malaria based on placental histopathology dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence and by histopathology as a categorical variable based on Rogerson et al criteria. (NCT02163447)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Mothers - 3 Dose SP49
Mothers - 3 Dose DP30
Mothers - Monthly DP26

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Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP

Prevalence of placental blood samples positive for parasites by microscopy or LAMP (NCT02163447)
Timeframe: Delivery

,,
InterventionParticipants (Count of Participants)
Micropscopic assessment of placental bloodLAMP assessment of placental blood
Mothers - 3 Dose DP33
Mothers - 3 Dose SP519
Mothers - Monthly DP02

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Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery

Prevalence of maternal parasitemia at delivery by microscopy and LAMP (NCT02163447)
Timeframe: At delivery

,,
Interventionparticipants (Number)
MicroscopyLAMP
Mothers - 3 Dose DP13
Mothers - 3 Dose SP525
Mothers - Monthly DP01

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Incidence of Malaria in Infants

episodes per person year (NCT02793622)
Timeframe: Time at risk will begin at birth and end when study participants reaches 12 months of age or early study termination

Interventionepisodes per person year (Number)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy1.98
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy1.71

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Incidence of Hospital Admissions in Infants

Admission to the pediatric ward for any cause (NCT02793622)
Timeframe: Birth up to 12 months of age or early termination

InterventionParticipants (Count of Participants)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy19
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy8

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Incidence of Complicated Malaria in Infants

Complicated malaria defined as an episode of malaria with danger signs (any of the following: less than 3 convulsions over 24 h, inability to sit or stand, vomiting everything, unable to breastfeed or drink) or the meeting standardized criteria for severe malaria. (NCT02793622)
Timeframe: Birth up to 12 months of age or early termination

InterventionParticipants (Count of Participants)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy44
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy24

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Prevalence of Maternal Malaria

Maternal blood positive for malaria parasites by microscopy. (NCT02793622)
Timeframe: Gestational age between 12-20 weeks (at study entry) up to delivery

InterventionParticipants (Count of Participants)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy28
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy1

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Prevalence of Placental Parasitemia

Proportion of placental blood samples positive for parasites by Loop-mediated isothermal amplification (LAMP) or microscopy (NCT02793622)
Timeframe: Delivery

,
InterventionParticipants (Count of Participants)
LAMPMicroscopy
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy71
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy7129

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Prevalence of Placental Malaria by Histology

Any evidence of placental infection (parasites or pigment). Number of participants with placental tissue positive for malaria parasites or pigment. (NCT02793622)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy197
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy94

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Prevalence of Asymptomatic Parasitemia in Pregnant Women

Proportion of routine monthly samples positive for parasites by microscopy and LAMP (NCT02793622)
Timeframe: Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery

Interventionblood smears (Count of Units)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy519
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy9

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Prevalence of Asymptomatic Parasitemia in Infants

Proportion of routine monthly samples positive for parasites by microscopy and LAMP (NCT02793622)
Timeframe: Birth up to 12 months of age or early termination

Interventionblood smears (Count of Units)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy344
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy357

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Prevalence of Anemia in Pregnant Women

hemoglobin < 11 g/dL (NCT02793622)
Timeframe: Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery

InterventionParticipants (Count of Participants)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy28
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy8

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Prevalence of Anemia in Infants

"Defined as the proportion with hemoglobin < 10 g/dL measure routinely at 12, 28, and 52 weeks of age. Number of cases per person year (PPY).~This is a prevalence measure but are repeated measures during infancy. In other words we measured this outcome up to 3 times for each participant during infancy (at 12, 28 and 52 weeks of age)." (NCT02793622)
Timeframe: Birth up to 12 months of age or early termination

Interventionroutine hemoglobin measurement (Count of Units)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy222
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy216

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Number of Participants With Adverse Events

All grade 3 and 4 adverse events (NCT02793622)
Timeframe: Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery

InterventionParticipants (Count of Participants)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy54
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy43

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Number of Participants Who Deliver With a Composite Adverse Birth Outcome

Composite adverse birth outcome defined as any one of the following: 1) Low birth weight (< 2500 gm); 2) Preterm delivery (< 37 weeks gestational age); 3) Small for gestational age (< 10th percentile relative to an external growth reference) (NCT02793622)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy60
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy54

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Mean Gestational Age in Weeks at Birth

Gestational age in weeks determined by ultrasound dating (gold standard) and by the metabolic profiling outcome from biological specimens including placental tissue and placental blood. (NCT02793622)
Timeframe: At the time of delivery

Interventionweeks (Mean)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy39.4
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy39.6

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Infant Mortality Rate

Any deaths occurring after birth (NCT02793622)
Timeframe: Birth up to 12 months of age

InterventionParticipants (Count of Participants)
Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy9
Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy7

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AUC Gametocytes

The area under the curve of gametocyte density versus time. The median AUC was calculated for both cohorts. Since onset of gametocytaemia differs depending on method of infection a window of 15 days was used to calculate AUC, from the time-point where a minimum of 50% of participants within a cohort had detectable gametocytemia. (NCT03454048)
Timeframe: up to day 51 after challenge infection

Intervention(gametocytes*days)/mL (Median)
Cohort A99
Cohort B11043

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Frequency of Adverse Events in the CHMI-trans Model

Frequency of adverse events in the CHMI-trans model. (NCT03454048)
Timeframe: up to day 51 after challenge infection

InterventionAdverse events (Number)
Group 1 (Cohort A) LD-PIP/LD-PIP2/PIP95
Group 2 (Cohort A) LD-PIP/LD-PIP2/SP95
Group 3 (Cohort B) LD-PIP/LD-PIP2/PIP107
Group 4 (Cohort B) LD-PIP/LD-PIP2/SP52

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Gametocyte Commitment

The gametocyte commitment rate is estimated by dividing the peak gametocyte by the peak of asexual parasites. (NCT03454048)
Timeframe: up to day 51 after challenge infection

Interventiongametocytes/asexual parasite (Median)
Cohort A0.0011
Cohort B0.0323

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Gametocyte Prevalence

Number of individuals in each study arm that show prevalence of gametocytes as defined by quantitative reverse-transcriptase PCR (qRT-PCR) for CCp4 (female) and PfMGET (male) mRNA with a threshold of 5 gametocytes/mL for positivity. (NCT03454048)
Timeframe: up to day 51 after challenge infection

InterventionParticipants (Count of Participants)
Group 1 (Cohort A) LD-PIP/LD-PIP2/PIP5
Group 2 (Cohort A) LD-PIP/LD-PIP2/SP6
Group 3 (Cohort B) LD-PIP/LD-PIP2/PIP6
Group 4 (Cohort B) LD-PIP/LD-PIP2/SP6

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Gametocyte Sex-ratio

Proportion of male gametocytes (NCT03454048)
Timeframe: up to day 51 after challenge infection

InterventionProportion of male gametocytes (Median)
Cohort A0.20
Cohort B0.31

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Number of Participants Infectious for Mosquitoes Through DFA

Prevalence of gametocyte infectiousness for Anopheles mosquitoes through Direct Feeding Assays (Direct Skin Feeding Assay, DFA). (NCT03454048)
Timeframe: up to day 51 after challenge infection

InterventionParticipants (Count of Participants)
Cohort A0
Cohort B9

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Peak Density Gametocytes

Peak density of gametocytes by qRT-PCR. (NCT03454048)
Timeframe: up to day 51 after challenge infection

InterventionGametocytes/mL (Median)
Group 1 (Cohort A) LD-PIP/LD-PIP2/PIP13.9
Group 2 (Cohort A) LD-PIP/LD-PIP2/SP21.4
Group 3 (Cohort B) LD-PIP/LD-PIP2/PIP1442.2
Group 4 (Cohort B) LD-PIP/LD-PIP2/SP813.2

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Magnitude of Adverse Events in the CHMI-trans Model

"symptoms will be ranked as (1) mild, (2) moderate, or (3) severe, depending on their intensity according to the following scale:~Mild (grade 1): awareness of symptoms that are easily tolerated and do not interfere with usual daily activity~Moderate (grade 2): discomfort that interferes with or limits usual daily activity~Severe (grade 3): disabling, with subsequent inability to perform usual daily activity, resulting in absence or required bed rest" (NCT03454048)
Timeframe: up to day 51 after challenge infection

,,,
InterventionAdverse events (Number)
Mild (grade I)Moderate (grade II)Severe (grade III)
Group 1 (Cohort A) LD-PIP/LD-PIP2/PIP64229
Group 2 (Cohort A) LD-PIP/LD-PIP2/SP562217
Group 3 (Cohort B) LD-PIP/LD-PIP2/PIP86174
Group 4 (Cohort B) LD-PIP/LD-PIP2/SP4183

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