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

Abstract Background The World Health Organization recommendation on the use of a single low dose of primaquine (SLD-PQ) to reduce Plasmodium falciparum malaria transmission requires more safety data. Methods We conducted an open-label, nonrandomized, dose-adjustment trial of the safety of 3 single d...

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Published in:The Journal of infectious diseases 2018-03, Vol.217 (8), p.1298-1308
Main Authors: Chen, Ingrid, Diawara, Halimatou, Mahamar, Almahamoudou, Sanogo, Koualy, Keita, Sekouba, Kone, Daouda, Diarra, Kalifa, Djimde, Moussa, Keita, Mohamed, Brown, Joelle, Roh, Michelle E, Hwang, Jimee, Pett, Helmi, Murphy, Maxwell, Niemi, Mikko, Greenhouse, Bryan, Bousema, Teun, Gosling, Roly, Dicko, Alassane
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cites cdi_FETCH-LOGICAL-c420t-c2d471ecf88f850767c825065f89279617841146f96981fe5c5e2ea820ef8b5a3
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container_title The Journal of infectious diseases
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creator Chen, Ingrid
Diawara, Halimatou
Mahamar, Almahamoudou
Sanogo, Koualy
Keita, Sekouba
Kone, Daouda
Diarra, Kalifa
Djimde, Moussa
Keita, Mohamed
Brown, Joelle
Roh, Michelle E
Hwang, Jimee
Pett, Helmi
Murphy, Maxwell
Niemi, Mikko
Greenhouse, Bryan
Bousema, Teun
Gosling, Roly
Dicko, Alassane
description Abstract Background The World Health Organization recommendation on the use of a single low dose of primaquine (SLD-PQ) to reduce Plasmodium falciparum malaria transmission requires more safety data. 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. Clinical Trials Registration NCT02535767. This phase 1, open-label, nonrandomized, dose-adjustment trial showed that single doses of primaquine between 0.40 and 0.50 mg/kg were well tolerated in G6PD-deficient and G6PD-normal males in Mali, supporting the World Health Organization recommendation on the use of a single low of dose primaquine to reduce Plasmodium falciparum malaria transmission.
doi_str_mv 10.1093/infdis/jiy014
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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. Clinical Trials Registration NCT02535767. This phase 1, open-label, nonrandomized, dose-adjustment trial showed that single doses of primaquine between 0.40 and 0.50 mg/kg were well tolerated in G6PD-deficient and G6PD-normal males in Mali, supporting the World Health Organization recommendation on the use of a single low of dose primaquine to reduce Plasmodium falciparum malaria transmission.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1093/infdis/jiy014</identifier><identifier>PMID: 29342267</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Major and Brief Reports</subject><ispartof>The Journal of infectious diseases, 2018-03, Vol.217 (8), p.1298-1308</ispartof><rights>The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c420t-c2d471ecf88f850767c825065f89279617841146f96981fe5c5e2ea820ef8b5a3</citedby><cites>FETCH-LOGICAL-c420t-c2d471ecf88f850767c825065f89279617841146f96981fe5c5e2ea820ef8b5a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29342267$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Ingrid</creatorcontrib><creatorcontrib>Diawara, Halimatou</creatorcontrib><creatorcontrib>Mahamar, Almahamoudou</creatorcontrib><creatorcontrib>Sanogo, Koualy</creatorcontrib><creatorcontrib>Keita, Sekouba</creatorcontrib><creatorcontrib>Kone, Daouda</creatorcontrib><creatorcontrib>Diarra, Kalifa</creatorcontrib><creatorcontrib>Djimde, Moussa</creatorcontrib><creatorcontrib>Keita, Mohamed</creatorcontrib><creatorcontrib>Brown, Joelle</creatorcontrib><creatorcontrib>Roh, Michelle E</creatorcontrib><creatorcontrib>Hwang, Jimee</creatorcontrib><creatorcontrib>Pett, Helmi</creatorcontrib><creatorcontrib>Murphy, Maxwell</creatorcontrib><creatorcontrib>Niemi, Mikko</creatorcontrib><creatorcontrib>Greenhouse, Bryan</creatorcontrib><creatorcontrib>Bousema, Teun</creatorcontrib><creatorcontrib>Gosling, Roly</creatorcontrib><creatorcontrib>Dicko, Alassane</creatorcontrib><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</title><title>The Journal of infectious diseases</title><addtitle>J Infect Dis</addtitle><description>Abstract Background The World Health Organization recommendation on the use of a single low dose of primaquine (SLD-PQ) to reduce Plasmodium falciparum malaria transmission requires more safety data. 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. Clinical Trials Registration NCT02535767. 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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. Clinical Trials Registration NCT02535767. This phase 1, open-label, nonrandomized, dose-adjustment trial showed that single doses of primaquine between 0.40 and 0.50 mg/kg were well tolerated in G6PD-deficient and G6PD-normal males in Mali, supporting the World Health Organization recommendation on the use of a single low of dose primaquine to reduce Plasmodium falciparum malaria transmission.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>29342267</pmid><doi>10.1093/infdis/jiy014</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record>
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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
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