Malaria: Assessing Methods and Progress Toward Malaria Elimination
Evaluation of the efficacy and safety of reducing doses of primaquine for clearance of gametocytes in uncomplicated falciparum malaria in children in Uganda
11/12/2012 4:30:00 PM
Alice C. Eziefula
, Sarah G. Staedke
, Emily Webb
, Moses Kamya
, Nicholas J. White
, Teun Bousema
, Shunmay Yeung
, Chris J. Drakeley
London School of Hygiene and Tropical Medicine, London, United Kingdom,
Infectious Diseases Research Collaboration, Kampala, Uganda,
Wellcome Trust Southeast Asian Tropical Medicine Research Programmes, Mahidol University & Oxford University, Bangkok, Thailand,
Radboud University Nijmegen Medical CentreCentre, The Netherlands & London School of Hygiene and Tropical Medicine, London, United Kingdom
Administration of the gametocytocidal drug primaquine (PQ) is a well-recognized tool to block transmission of malaria from humans to mosquitoes. The World Health Organization (WHO) has recommended adding a single dose of PQ to artemisinin-based combination treatment for falciparum malaria, particularly as a component of an elimination program. However, in individuals with glucose-6-phosphate dehydrogenase deficiency (G6PDd), PQ can cause life-threatening hemolysis, which has restricted its widespread use in regions where G6PDd is prevalent. This adverse effect is dose-dependent. We hypothesize that administration of PQ at a dose lower than that recommended by the WHO (0.75 mg/kg) will be safer than, yet as efficacious as, the WHO dose. We are currently conducting a randomized, double-blinded, placebo-controlled clinical trial to compare the efficacy and safety of three doses of PQ in Uganda. Children aged 1-10 years with uncomplicated falciparum malaria and normal G6PD status are recruited and treated with artemether-lumefantrine. On the third day of treatment, participants are randomized to receive 0.1mg/kg, 0.4mg/kg or 0.75mg/kg of PQ, or placebo. Participants are followed up for 28 days with repeated blood sampling. Efficacy outcomes include the number of days to gametocyte clearance (measured by quantitative real-time nucleic acid sequence-based amplification [QT-NASBA] on days 0-14, and the area under the curve of QT-NASBA-measured gametocyte density over time. Safety outcomes are the mean maximal change in hemoglobin on days 0-28, requirement for blood transfusion, evidence of hemolysis and incidence of adverse events. Efficacy analysis will be conducted for non-inferiority of each reduced dose of PQ treatment compared to the WHO-recommended dose. For safety, the superiority of test doses to standard dose will be assessed. Recruitment started end-December 2011 and 200 (42%) of the target sample size of 480 participants have been recruited to date. Complete, un-blinded results and full results of safety and tolerability will be presented.
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