drugset / Trial / NCT00852371
Intermittent Preventive Treatment of Malaria in Schoolchildren
Phase 3
Completed
780 enrolled
London School of Hygiene and Tropical Medicine
Ministry of Health, Uganda · collabUganda Malaria Surveillance Project · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2008-02
- Primary completion
- 2008-06
- Completion
- 2008-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ARTENIMOL | Small molecule | 2.1 mg/kg | — |
| Comparator | amodiaquine | Other / unclassified | 10 mg/kg | Oral |
| Comparator | piperaquine | Small molecule | 17.1 mg/kg | — |
| Comparator | pyrimethamine | Small molecule | 1.25 mg/kg | Oral |
| Comparator | sulfadoxine | Small molecule | 25 mg/kg | Oral |