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Published on: January 16, 2015
Intermittent preventive treatment against malaria in infants in Gabon--a randomized, double-blind, placebo-controlled
Martin P Grobusch1, Bertrand Lell, Norbert G Schwarz
1Medical Research Unit, Albert Schweitzer Hospital, Lambarene, Gabon. martin.grobusch@wits.ac.za
Insights
Sulfadoxine-pyrimethamine (SP) intermittent preventive treatment in Gabonese infants reduced anemia risk. While safe and well-tolerated, its effect on malaria was smaller, highlighting its value for anemia control in this vulnerable group.
Area of Science:
- Tropical Medicine
- Pediatric Infectious Diseases
- Pharmacology
Background:
- Intermittent preventive treatment (IPT) strategies aim to optimize malaria chemoprophylaxis efficacy while minimizing adverse effects.
- Sulfadoxine-pyrimethamine (SP) is a key antimalarial drug used in IPT regimens.
- Infants represent a highly vulnerable population susceptible to malaria and its complications.
Purpose of the Study:
- To evaluate the efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) in infants in Gabon.
- To assess the impact of SP on anemia and malaria episodes in infants up to 18 months of age.
Main Methods:
- A randomized, placebo-controlled trial involving 1189 infants in Gabon.
- Infants received SP (250 mg sulfadoxine; 12.5 mg pyrimethamine) or placebo at 3, 9, and 15 months of age.
- Active follow-up was conducted until 18 months of age, with data analyzed on an intention-to-treat basis.
Main Results:
- In the intention-to-treat population, 17% of infants in the SP group experienced anemia versus 21% in the placebo group (protective efficacy 22%; P=.06).
- SP showed a protective efficacy of 17% against malaria episodes (P=.36), with similar effects observed at 12 months.
- The study drug was found to be safe and well-tolerated in the infant population.
Conclusions:
- Intermittent preventive treatment with SP demonstrated efficacy in reducing anemia risk among Gabonese infants.
- SP serves as a valuable tool for malaria control, particularly for reducing anemia in this high-risk age group.
- Further research is ongoing to address remaining questions regarding SP's role in malaria prevention.
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.
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