drugset / Trial / NCT04370977
In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children (MEFI_III)
Phase 4
Completed
630 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 4 sites of the two oral ACTS artemether-lumefantrine (AL) and Amodiaquine-Artesunate (AQ-AS), first line treatment for malaria in mozambique, for the treatment of uncomplicated malaria in children aged\<5 years.
Timeline
- Start
- 2018-03-21
- Primary completion
- 2018-09-29
- Completion
- 2019-12-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | 25 mg | Oral |
| Comparator | Artesunate | Small molecule | 50 mg | Oral |
| Comparator | Artesunate | Small molecule | 100 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 |