A Trial of Intermittent Treatment in the Prevention of Malaria in Senegalese Children

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly all infections occurring during a few months of the year. However, mortality and morbidity from malaria may be high during this period, especially in young children who are the group most at risk.

Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in this situation. IPT involves the administration of an anti-malarial to children at risk for malaria at fixed times, even if they are not infected. To investigate how effective this approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three occasions during a three-month rainy season and the incidence of clinical malaria in these children was compared with that in a group of children who received placebo. Additional observations were made on the incidence of side effects in children in the two groups and on the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood films were positive for Plasmodium falciparum.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gates Malaria Partnership; London School of Hygiene and Tropical Medicine
• Collaborators: Cheikh Anta Diop University, Senegal; Institut de Recherche pour le Developpement; Institut de Recherche pour le Developpement, Senegal; Ministry of Health, Senegal
• Treatments: Artesunate; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Ages 6 weeks to 59 months

• Residence in the study area

• Informed consent

Exclusion Criteria:

• Known allergy to study drugs

• Serious underlying illness