drugset / Trial / NCT03768908
Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine for Falciparum Malaria in Zanzibar, 2005
Phase 4
Completed
359 enrolled
Professor Anders Björkman
Zanzibar Malaria Control Programme · collab
RandomizedOpen-labelTreatment
Summary
The primary objective of the study was to determine the PCR-APCR up to day 42 in children \<60 months of age, weighing ≥5kg with uncomplicated malaria, treated with either artesunate+ amodiaquine (ASAQ) or artemether-lumefantrine (AL; Coartem®). Secondary objectives included: clinical and laboratory assessment of drug tolerability and safety, evaluation of possible correlation between drug bioavailability and clinical outcome, comparison of efficacy data with the pre-implementation "ACO I" study, parasite and fever clearance, gametocyte carriage, and possible selection of mutations related to quinoline resistance.
Timeline
- Start
- 2005-01-05
- Primary completion
- 2005-07-11
- Completion
- 2005-07-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether | Small molecule | 1.3 mg/kg | — |
| Comparator | Artemether-lumefantrine | Unknown | 1.3 mg/kg | — |
| Comparator | Artemether-lumefantrine | Unknown | 4 mg/kg | — |
| Comparator | Artesunate | Small molecule | 4 mg/kg | — |
| Comparator | Artesunate + Amodiaquine | Unknown | 4 mg/kg | — |
| Comparator | Artesunate + Amodiaquine | Unknown | 10 mg/kg | — |
| Comparator | amodiaquine | Other / unclassified | 10 mg/kg | — |
| Comparator | lumefantrine | Small molecule | 4 mg/kg | — |