Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria
combination drugs (ACTs) for the treatment of children aged 6-120 months in different
locations in Cameroon. Randomized clinical trials will provide local data on the safety of
the test drugs, and on putative marker mutations of the development of resistance to ACT. The
study will involve three centers, namely, Banso (Guinea-Savannah region), Limbe(Littoral
Forest), and Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of
Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be
determined using a WHO standardized 28-day protocol. Safety will be monitored through
clinical examination and biochemical and hematological indices. Molecular markers of
artemisinin resistance will be investigated by molecular sequencing and comparison of
parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections
will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on
generation of gametocytes will be determined from gametocyte carriage rates measured by
microscopy.
Phase:
Phase 3
Details
Lead Sponsor:
Gates Malaria Partnership London School of Hygiene and Tropical Medicine
Collaborators:
Cameroon Baptist Convention Health University of Yaounde