1. Intermittent preventive treatment against malaria in infants in Gabon--a randomized, double-blind, placebo-controlled trial.
- Author
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Grobusch MP, Lell B, Schwarz NG, Gabor J, Dornemann J, Potschke M, Oyakhirome S, Kiessling GC, Necek M, Langin MU, Klein Klouwenberg P, Klopfer A, Naumann B, Altun H, Agnandji ST, Goesch J, Decker M, Salazar CL, Supan C, Kombila DU, Borchert L, Koster KB, Pongratz P, Adegnika AA, Glasenapp Iv, Issifou S, and Kremsner PG
- Subjects
- Anemia chemically induced, Anemia epidemiology, Antimalarials adverse effects, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Female, Gabon epidemiology, Hematocrit, Hemoglobins metabolism, Humans, Incidence, Infant, Kaplan-Meier Estimate, Malaria, Falciparum blood, Malaria, Falciparum epidemiology, Male, Parasitemia blood, Parasitemia epidemiology, Parasitemia parasitology, Patient Selection, Pyrimethamine adverse effects, Research Design, Sulfadoxine adverse effects, Treatment Outcome, Antimalarials administration & dosage, Malaria, Falciparum prevention & control, Parasitemia prevention & control, Pyrimethamine administration & dosage, Sulfadoxine administration & dosage
- Abstract
Background: Intermittent preventive treatment aims to maximize the protective effects of malaria chemoprophylaxis while minimizing the deleterious effects., Methods: In Gabon, 1189 infants received either sulfadoxine-pyrimethamine (SP; 250 and 12.5 mg, respectively) or placebo at 3, 9, and 15 months of age. Children were actively followed-up until 18 months of age., Results: In the intention-to-treat population at 18 months of follow-up, 84 children (17%) in the SP group had > or =1 episode of anemia, versus 108 (21%) in the placebo group (protective efficacy, 22% [95% confidence interval {CI}, -1% to 40%]; P=.06). In the intervention group, there were 66 episodes during 485 person-years at risk, compared with 79 episodes during 497 years in the placebo group (protective efficacy, 17% [95% CI, -24% to 45%; P=.36). The effects were similar at 12 months of follow-up. The study drug was safe and well tolerated., Conclusions: The intervention was efficacious, producing a reduction in risk for anemia but a smaller effect against malaria. It is a valuable additional tool to control malaria in a highly vulnerable age group. Remaining important questions are currently being addressed in further studies., Trial Registration: ClinicalTrials.gov identifier: NCT00167843.
- Published
- 2007
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