drugset / Trial / NCT03939104
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia)
Phase 3
Completed
103 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 (AS-MQ+PPQ) with the ACTs artemether-lumefantrine + placebo (AL+PBO) and artesunate- mefloquine + placebo (AS-MQ+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
- 2021-06-30
- Primary completion
- 2023-01-06
- Completion
- 2023-01-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether-lumefantrine | Unknown | — | — |
| Comparator | Artesunate | Small molecule | 4 mg/kg | — |
| Comparator | Mefloquine | Unknown | 8.3 mg/kg | — |
| Comparator | amodiaquine | Other / unclassified | 10 mg/kg | — |
| Comparator | piperaquine | Small molecule | 18 mg/kg | — |
| Comparator | piperaquine | Small molecule | 24 mg/kg | — |