drugset / Trial / NCT01845701

Artemisinin-Based Antimalarial Combinations and Clinical Response in Cameroon

NCT01845701

RandomizedParallel-groupDouble-blindTreatment

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

EvaluationDrugModalityDoseRoute
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

Indications