Safety of Single-Dose Primaquine in G6PD-Deficient and G6PD-Normal Males in Mali Without Malaria : An Open-Label, Phase 1, Dose-Adjustment Trial

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Chen , I , Diawara , H , Mahamar , A , Sanogo , K , Keita , S , Kone , D , Diarra , K , Djimde , M , Keita , M , Brown , J , Roh , M E , Hwang , J , Pett , H , Murphy , M , Niemi , M , Greenhouse , B , Bousema , T , Gosling , R & Dicko , A 2018 , ' Safety of Single-Dose Primaquine in G6PD-Deficient and G6PD-Normal Males in Mali Without Malaria : An Open-Label, Phase 1, Dose-Adjustment Trial ' , Journal of Infectious Diseases , vol. 217 , no. 8 , pp. 1298-1308 . https://doi.org/10.1093/infdis/jiy014

Title: Safety of Single-Dose Primaquine in G6PD-Deficient and G6PD-Normal Males in Mali Without Malaria : An Open-Label, Phase 1, Dose-Adjustment Trial
Author: Chen, Ingrid; Diawara, Halimatou; Mahamar, Almahamoudou; Sanogo, Koualy; Keita, Sekouba; Kone, Daouda; Diarra, Kalifa; Djimde, Mousse; Keita, Mohamed; Brown, Joelle; Roh, Michelle E.; Hwang, Jimee; Pett, Helmi; Murphy, Maxwell; Niemi, Mikko; Greenhouse, Bryan; Bousema, Teun; Gosling, Roly; Dicko, Alassane
Contributor: University of Helsinki, Clinicum
University of Helsinki, Medicum
Date: 2018-04-15
Language: eng
Number of pages: 11
Belongs to series: Journal of Infectious Diseases
ISSN: 0022-1899
URI: http://hdl.handle.net/10138/235283
Abstract: Methods: We conducted an open-label, nonrandomized, dose-adjustment trial of the safety of 3 single doses of primaquine in glucose-6-phosphate dehydrogenase (G6PD)-deficient adult males in Mali, followed by an assessment of safety in G6PD-deficient boys aged 11–17 years and those aged 5–10 years, including G6PD-normal control groups. The primary outcome was the greatest within-person percentage drop in hemoglobin concentration within 10 days after treatment. Results: Fifty-one participants were included in analysis. G6PD-deficient adult males received 0.40, 0.45, or 0.50 mg/kg of SLD-PQ. G6PD-deficient boys received 0.40 mg/kg of SLD-PQ. There was no evidence of symptomatic hemolysis, and adverse events considered related to study drug (n = 4) were mild. The mean largest within-person percentage change in hemoglobin level between days 0 and 10 was −9.7% (95% confidence interval [CI], −13.5% to −5.90%) in G6PD-deficient adults receiving 0.50 mg/kg of SLD-PQ, −11.5% (95% CI, −16.1% to −6.96%) in G6PD-deficient boys aged 11–17 years, and −9.61% (95% CI, −7.59% to −13.9%) in G6PD-deficient boys aged 5–10 years. The lowest hemoglobin concentration at any point during the study was 92 g/L. Conclusion: SLD-PQ doses between 0.40 and 0.50 mg/kg were well tolerated in G6PD-deficient males in Mali.
Subject: Primaquine
Plasmodium falciparum
malaria
transmission
G6PD deficiency
drug safety
hemolysis
mass drug administration
PLASMODIUM-FALCIPARUM MALARIA
RANDOMIZED CONTROLLED-TRIAL
DEFICIENCY
TRANSMISSION
HEMOLYSIS
EFFICACY
AFRICA
3121 General medicine, internal medicine and other clinical medicine
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