Falciparum Malaria Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of Primaquine for Clearance of Gametocytes in Uncomplicated Falciparum Malaria in Uganda
The purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine compared to the dose recommended by the WHO for reducing P. falciparum gametocytes in the infected human host to prevent transmission of falciparum malaria to the anopheles mosquito vector.
A single dose of 0.75mg/kg primaquine base is recommended by the WHO to block transmission
of falciparum malaria from infected humans to mosquitoes by clearing gametocytes. However,
the optimal dose for safety and efficacy has not been evaluated. Dose-finding data is
important because primaquine has a dose-dependent risk of causing haemolysis (destruction of
blood cells) in pre-disposed individuals, such as those with G6PD deficiency. G6PD
deficiency is most prevalent in malaria-endemic areas. Therefore, it is essential that data
on primaquine's safety is available in such areas.
The investigators hypothesise that lower doses of primaquine have a lower risk of adverse
effects compared to the WHO-recommended dose, but retain the transmission-blocking efficacy.
The investigators propose to test this hypothesis in a four-arm clinical trial with a
non-inferiority design to evaluate the efficacy and a superiority design to evaluate the
safety of the WHO dose (0.75mg/kg) and lower doses of primaquine for clearance of P.
falciparum gametocytes in children in Uganda. The study will include a pharmacokinetic
analysis.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
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