drugset / Trial / NCT00902811

Effectiveness of Artemisinin Combination Regimens in Falciparum Malaria

NCT00902811

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region. Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.

Timeline

Start
2008-12
Primary completion
2009-10
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ARTENIMOL Small molecule 20 mg
Subject ARTENIMOL Small molecule 40 mg
Subject Artemether Small molecule 20 mg
Subject Artesunate Small molecule 4 mg/kg
Subject Artesunate Small molecule 25 mg
Subject Artesunate Small molecule 50 mg
Subject Artesunate Small molecule 100 mg
Comparator Mefloquine Unknown 25 mg/kg
Comparator Mefloquine Unknown 55 mg
Comparator Mefloquine Unknown 220 mg
Subject amodiaquine Other / unclassified 67.5 mg
Subject amodiaquine Other / unclassified 135 mg
Subject amodiaquine Other / unclassified 270 mg
Subject lumefantrine Small molecule 120 mg
Subject piperaquine Small molecule 160 mg
Subject piperaquine Small molecule 320 mg