Plasmodium Falciparum Clinical Trial
Official title:
Efficacy and Safety of a Single Low-dose Primaquine Added to Standard Artemether-lumefantrine Treatment for the Clearance of Plasmodium Falciparum Gametocytes.
The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine added to standard artemether/lumefantrine treatment for the clearance of Plasmodium falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above regardless of their G6PD status.
The current gained successes in malaria control are accredited partly to the availability of
efficacious and fast acting artemisinins which are also potent against P. falciparum young
gametocytes. Nonetheless, mature gametocytes may persist after treatment, contributing to
malaria transmission. Conversely, artemisinin resistance is confirmed in South-east Asia,
and it may spread to Africa. New control tools have to be integrated to sustain the gained
successes, further reduce transmission and curb the spread of resistance.
Primaquine has strong gametocytocidal effect against mature gametocytes and when added to
schizonticidal drugs such as artemether-lumefantrine (AL), it rapidly shorten gametocytes
carriage duration, halting disease transmission. Nonetheless, its wide scale use has been
hampered by a dose-dependent acute hemolytic anemia it causes in glucose-6-phosphate
dehydrogenase (G6PD) deficient individuals. Conversely, Artemisinins potentiate primaquine
activities, thus a low dose of primaquine would be able to clear falciparum gametocytes.
The World Health Organization recommends addition of 0.25 mg/kg single-dose primaquine to
Artemisinin based combination therapies in malaria endemic areas including Africa without
testing for G6PD status. Nonetheless, the recommendation, relies on historical data from
South-East Asia and among African Americans in the United States. Therefore, this study
plans to assess safety and efficacy of 0.25 mg/kg single-dose primaquine added to a standard
AL treatment against P. falciparum gametocytes clearance among patients with uncomplicated
malaria aged 1 year and above regardless of their G6PD status..
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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