drugset / Trial / NCT02168569
In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children
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 two oral ACTS artemether-lumefantrine (AL) and Amodiaquine-Artesunate (AQ-AS), first and second line treatment for malaria in mozambique, respectively, for the treatment of uncomplicated malaria in children aged\<5 years.
Timeline
- Start
- 2011-06
- Primary completion
- 2012-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether | Small molecule | 20 mg | — |
| Comparator | Artemether | Small molecule | 40 mg | — |
| Comparator | Artemether | Small molecule | 60 mg | — |
| Comparator | Artesunate | Small molecule | 25 mg | — |
| Comparator | Artesunate | Small molecule | 50 mg | — |
| Comparator | Artesunate | Small molecule | 100 mg | — |
| Comparator | amodiaquine | Other / unclassified | 67.5 mg | — |
| Comparator | amodiaquine | Other / unclassified | 135 mg | — |
| Comparator | amodiaquine | Other / unclassified | 270 mg | — |
| Comparator | lumefantrine | Small molecule | 120 mg | — |
| Comparator | lumefantrine | Small molecule | 240 mg | — |
| Comparator | lumefantrine | Small molecule | 360 mg | — |