Malaria Clinical Trial
Official title:
Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya
Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated
malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of
Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line
treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives
are the most rapidly acting of all the current antimalarial drugs and recognition of their
potential role as a component of combination therapy have led to several large trials aimed
at assessing different combinations of existing drugs, and to the specific development of
new combination drugs.
This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria
combination drugs in different sites across Kenya (2) elucidate the markers of resistance to
ACTs through molecular genetics and in this process further strengthen capacity in the
proposed study sites as well as improve links between research and control ultimately to
influence malaria treatment policy and practice.
Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess
the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative
drug. The network will determine antimalarial drug efficacy using standardised protocols and
collate clinical responses and adverse events. Molecular markers to artemisinin resistance
will be investigated by molecular sequencing and comparison of parasite profiles in drug
failure cases. Recrudescence or re-infections will be differentiated by analysis of the
MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these
studies will be captured into a database developed by the network. The latter offers several
advantages including
- Working towards the standardization of methodologies and common protocols as a way of
comparing data across sites
- Pulling together datasets and conduct a multi-centre analysis
- Sharing and coordinating quality assurance mechanisms
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
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