drugset / Trial / NCT03764527
Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar
Phase 4
Completed
408 enrolled
Professor Anders Björkman
World Health Organization · collabZanzibar Malaria Control Programme · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or Coartem®. Secondary objectives were to determine safety and possible selection of mutations related to the resistance of the tested drugs.
Timeline
- Start
- 2002-11-01
- Primary completion
- 2003-02-17
- Completion
- 2003-02-17
Publications
- Results Martensson A, Stromberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, Olliaro P, Ali AS, Bjorkman A. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005 Oct 15;41(8):1079-86. doi: 10.1086/444460. Epub 2005 Sep 13.
- Results Sisowath C, Ferreira PE, Bustamante LY, Dahlstrom S, Martensson A, Bjorkman A, Krishna S, Gil JP. The role of pfmdr1 in Plasmodium falciparum tolerance to artemether-lumefantrine in Africa. Trop Med Int Health. 2007 Jun;12(6):736-42. doi: 10.1111/j.1365-3156.2007.01843.x.
- Results Holmgren G, Hamrin J, Svard J, Martensson A, Gil JP, Bjorkman A. Selection of pfmdr1 mutations after amodiaquine monotherapy and amodiaquine plus artemisinin combination therapy in East Africa. Infect Genet Evol. 2007 Sep;7(5):562-9. doi: 10.1016/j.meegid.2007.03.005. Epub 2007 Mar 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether-lumefantrine | Unknown | — | — |
| Comparator | Artesunate | Small molecule | 4 mg/kg | — |
| Comparator | amodiaquine | Other / unclassified | 10 mg/kg | — |