Intermittent preventive treatment against malaria in infants in Gabon - A randomized, double-blind, placebo-controlled trial

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 ≥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. © 2007 by the Infectious Diseases Society of America. All rights reserved.