Malaria Clinical Trial
Official title:
Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children
The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations
(ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ),
artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and
repeat treatments of uncomplicated malaria in children. Safety will be determined by
registering adverse events and grading, laboratory, and vital signs evaluations. Their
incidence will be compared between the different study arms.
TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of
the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap
plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A
formal amendment has been submitted to all the concerned ECs and competent authorities. The
leading EC approved the amendment on 2nd June 2008.
TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008,
and because of the unavailability of a new batch of DHAPQ from the manufacturer, the
recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment
has been submitted to all the concerned ECs and competent authorities.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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