drugset / Trial / NCT03923725
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.
Phase 3
Completed
2583 enrolled
University of Oxford
Mahidol Oxford Tropical Medicine Research Unit · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.
Timeline
- Start
- 2020-09-01
- Primary completion
- 2024-03-15
- Completion
- 2024-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether | Small molecule | — | — |
| Comparator | Artesunate | Small molecule | 4 mg/kg | — |
| Comparator | Mefloquine | Unknown | 8.3 mg/kg | — |
| Subject | amodiaquine | Other / unclassified | 10 mg/kg | — |
| Comparator | lumefantrine | Small molecule | — | — |
| Subject | piperaquine | Small molecule | 18 mg/kg | — |
| Subject | piperaquine | Small molecule | 24 mg/kg | — |