drugset / Trial / NCT05343312
In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique
Phase 4
Completed
870 enrolled
Manhiça Health Research Centre
United States Agency for International Development (USAID) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in 5 sites of the four oral ACTS artemether-lumefantrine (AL), Amodiaquine-Artesunate (AQ-AS), Dihydroartemisinin-Piperaquine (DHP) and Pironaridine-Artesunate for the treatment of uncomplicated malaria in children aged\<5 years.
Timeline
- Start
- 2022-03-16
- Primary completion
- 2023-09-30
- Completion
- 2025-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ARTENIMOL | Small molecule | 20 mg | Oral |
| Comparator | ARTENIMOL | Small molecule | 40 mg | Oral |
| Comparator | ARTENIMOL | Small molecule | 80 mg | Oral |
| Comparator | Artemether | Small molecule | 20 mg | Oral |
| Comparator | Artemether | Small molecule | 40 mg | Oral |
| Comparator | Artemether | Small molecule | 60 mg | Oral |
| Comparator | Artesunate | Small molecule | 20 mg | Oral |
| Comparator | Artesunate | Small molecule | 25 mg | Oral |
| Comparator | Artesunate | Small molecule | 40 mg | Oral |
| Comparator | Artesunate | Small molecule | 50 mg | Oral |
| Comparator | Artesunate | Small molecule | 60 mg | Oral |
| Comparator | Artesunate | Small molecule | 100 mg | Oral |
| Comparator | Artesunate | Small molecule | 120 mg | Oral |
| Comparator | Pyronaridine | Unknown | 60 mg | Oral |
| Comparator | Pyronaridine | Unknown | 120 mg | Oral |
| Comparator | Pyronaridine | Unknown | 180 mg | Oral |
| Comparator | Pyronaridine | Unknown | 360 mg | Oral |
| Comparator | amodiaquine | Other / unclassified | 67.5 mg | Oral |
| Comparator | amodiaquine | Other / unclassified | 135 mg | Oral |
| Comparator | amodiaquine | Other / unclassified | 270 mg | Oral |
| Comparator | lumefantrine | Small molecule | 120 mg | Oral |
| Comparator | lumefantrine | Small molecule | 240 mg | Oral |
| Comparator | lumefantrine | Small molecule | 360 mg | Oral |
| Comparator | piperaquine | Small molecule | 160 mg | Oral |
| Comparator | piperaquine | Small molecule | 320 mg | Oral |
| Comparator | piperaquine | Small molecule | 640 mg | Oral |