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Longitudinal Comparison of Combination Antimalarial Therapies in Ugandan Children: Evaluation of Safety, Tolerability, and Efficacy
The purpose of this study is to compare different ways of treating uncomplicated malaria in a group of Ugandan children. The study will be divided into 2 parts. Part 1 of the study will consist of 600 children, ages 1-10, living in the Mulago III Parish of Kampala. Approximately 90 children living in the same household as children from the Phase 1 portion of the study will be enrolled in Phase II of this study. Participants in Phase II of the study will receive an insecticide treated net to cover their bed. Over the course of the study, participants will be tested for malaria when they present to the clinic with a fever or illness. Participants that test positive for malaria will be given 1 of 3 possible study drug combinations. Study procedures will include physical exams and blood samples. Children will participate for about 3 years. Protocol 05-0110 is a study related to this protocol.
Details
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 601 |
| Start date | 2004-11 |
| Completion | 2008-12 |
Conditions
- Malaria
Interventions
- Amodiaquine+Artesunate
- Amodiaquine+Sulfadoxine/Pyrimethamine
- Artemether+Lumefantrine
Primary outcomes
- Annual incidence of malaria per treatment arm — duration of study
Countries
Uganda