Intermittent Preventive Treatment of Malaria in Schoolchildren

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gates Malaria Partnership; London School of Hygiene and Tropical Medicine
• Collaborators: London School of Hygiene and Tropical Medicine; Ministry of Health, Uganda; Uganda Malaria Surveillance Project
• Treatments: Amodiaquine; Artemisinins; Artenimol; Dihydroartemisinin; Fanasil, pyrimethamine drug combination; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Age ≥ 8 to < 14 years (boys), ≥ 8 to < 12 years (girls)

• Student enrolled at participating school in classes 3-7

• Provision of informed consent from parent or guardian

• Provision of assent by student

Exclusion Criteria:

• Known allergy or history of adverse reaction to study medications

• Onset of menstruation (girls)

• Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours

• Evidence of severe malaria or danger signs

• Haemoglobin < 7.0 gm/dL

• Parasite density > 10,000/ul