Artemisinin-Based Antimalarial Combinations and Clinical Response in Cameroon
Summary
To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in comparison with artemether-lumefantrine during 42 days follow up period in 720 children with acute uncomplicated P. falciparum malaria, in two different endemic ecological areas - Savanna and equatorial forest regions of Cameroon. We have set as specific objectives: * To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in comparison with artemether-lumefantrine during 14 and 28 days follow up period in children with acute uncomplicated P. falciparum malaria in two different endemic areas. * To evaluate the safety of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in comparison with artemether-lumefantrine during 42 days follow up period in children with acute uncomplicated P. falciparum malaria. * To determine parasite clearance time (PCT) and fever clearance time (FCT) following the administration of the three trial regimens. * To investigate the treatment response based on WHO criteria (WHO, 2003) in patients in all groups after trial. * To investigate the Single Nucleotide Polymorphisms (SNPs) and microsatellite markers of genes associated with drug resistance
Timeline
- Start
- 2010-03
- Primary completion
- 2014-04
- Completion
- 2015-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 20 mg | Oral |
| Comparator | Artemether | Small molecule | 20 mg | Oral |
| Subject | Artesunate | Small molecule | 25 mg | Oral |
| Subject | amodiaquine | Other / unclassified | 67.5 mg | Oral |
| Comparator | lumefantrine | Small molecule | 120 mg | Oral |
| Subject | piperaquine | Small molecule | 160 mg | Oral |