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The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial

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Title
The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial
Published in
Trials, March 2015
DOI 10.1186/s13063-015-0597-1
Pubmed ID
Authors

Joseph Okebe, Teun Bousema, Muna Affara, GianLuca DiTanna, Alice C Eziefula, Musa Jawara, Davis Nwakanma, Alfred Amambua-Ngwa, Jean-Pierre Van geertruyden, Chris Drakeley, Umberto D’Alessandro

Abstract

Finding efficacious tools to decrease and interrupt malaria transmission is essential to sustain the gains in malaria control and contain the emergence of artemisinin resistance. Primaquine is effective against Plasmodium falciparum gametocytes and recommended for treatment campaigns in (pre-)elimination settings. Safety concerns preclude its use in endemic African countries with variable proportions of glucose-6-phosphate dehydrogenase (G6PD)-deficient individuals. The efficacy of the current recommended dose needs to be evaluated, particularly in individuals with an asymptomatic malaria infection. This is a four-arm, open label, randomized controlled trial that aims to determine and compare the effect of three different single doses of primaquine combined with dihydroartemisinin-piperaquine, an artemisinin-based combination therapy, on gametocyte carriage in asymptomatic, malaria infected, G6PD-normal individuals. Approximately 1,200 participants are enrolled and followed for 42 days, with the primary endpoint being the prevalence of Plasmodium falciparum gametocyte carriage at day 7 of follow-up determined by quantitative nucleic acid sequence based amplification assay. Direct membrane feeding experiments to determine infectiousness to mosquitoes are conducted as a biological secondary endpoint. Sub-Saharan Africa, with a relatively high but poorly characterized G6PD prevalence, could potentially benefit from the use of primaquine to further reduce or interrupt malaria transmission. However, G6PD screening may not be feasible given the cost and difficulties in interpreting test results in terms of risk of haemolysis. Because the haemolytic effect of primaquine is dose-dependent, determining the minimal gametocytocidal and transmission-blocking dose of primaquine is extremely important to help address public health concerns over its safety and validate the efficacy of lower than recommended dosages. By including infectiousness to mosquitoes, the trial provides complementary evidence for the potential of the drug to interrupt transmission to mosquitoes. ClinicalTrials.gov: NCT01838902 (12 April 2013).

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The data shown below were compiled from readership statistics for 90 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 2 2%
Burkina Faso 1 1%
Unknown 87 97%

Demographic breakdown

Readers by professional status Count As %
Researcher 25 28%
Student > Master 9 10%
Student > Postgraduate 8 9%
Student > Ph. D. Student 5 6%
Other 4 4%
Other 13 14%
Unknown 26 29%
Readers by discipline Count As %
Medicine and Dentistry 25 28%
Agricultural and Biological Sciences 9 10%
Biochemistry, Genetics and Molecular Biology 8 9%
Social Sciences 4 4%
Nursing and Health Professions 2 2%
Other 12 13%
Unknown 30 33%