Data from: Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: two open-label, randomized, safety trials
dc.contributor.affiliation | Medical Research Council - Okebe, Joseph | |
dc.contributor.affiliation | Medical Research Council - Affara, Muna | |
dc.contributor.affiliation | London School of Hygiene & Tropical Medicine - Bradley, John | |
dc.contributor.affiliation | Radboud University Nijmegen - Lanke, Kjerstin H. W. | |
dc.contributor.affiliation | University of Helsinki - Niemi, Mikko | |
dc.contributor.affiliation | Radboud University Nijmegen - Bousema, Teun | |
dc.contributor.affiliation | Radboud University Nijmegen - Bastiaens, Guido J. H. | |
dc.contributor.affiliation | University of Helsinki - Pett, Helmi E. | |
dc.contributor.affiliation | Medical Research Council - d'Alessandro, Umberto | |
dc.contributor.author | Bastiaens, Guido | |
dc.contributor.author | Tiono, Alfred B. | |
dc.contributor.author | Okebe, Joseph | |
dc.contributor.author | Pett, Helmi | |
dc.contributor.author | Coulibaly, Sam A. | |
dc.contributor.author | Gonçalves, Bronner P. | |
dc.contributor.author | Affara, Muna | |
dc.contributor.author | Ouédraogo, Alphonse | |
dc.contributor.author | Bougouma, Edith C. | |
dc.contributor.author | Sanou, Guillaume S. | |
dc.contributor.author | Nébié, Issa | |
dc.contributor.author | Bradley, John | |
dc.contributor.author | Lanke, Kjerstin H. W. | |
dc.contributor.author | Niemi, Mikko | |
dc.contributor.author | Sirima, Sodiomon B. | |
dc.contributor.author | d'Alessandro, Umberto | |
dc.contributor.author | Bousema, Teun | |
dc.contributor.author | Drakeley, Chris | |
dc.contributor.author | Bastiaens, Guido J. H. | |
dc.contributor.author | Pett, Helmi E. | |
dc.contributor.author | d'Alessandro, Umberto | |
dc.coverage.spatial | The Gambia | |
dc.coverage.spatial | Burkina Faso | |
dc.date.accessioned | 2025-03-24T15:18:54Z | |
dc.date.issued | 2018-12-18 | |
dc.date.issued | 2018-12-18 | |
dc.description | Background: Primaquine (PQ) actively clears mature Plasmodium falciparum gametocytes but in glucose-6-phosphate dehydrogenase deficient (G6PDd) individuals can cause hemolysis. We assessed the safety of low-dose PQ in combination with artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) in G6PDd African males with asymptomatic P. falciparum malaria. Methods and findings: In Burkina Faso, G6PDd adult males were randomized to treatment with AL alone (n = 10) or with PQ at 0.25 (n = 20) or 0.40 mg/kg (n = 20) dosage; G6PD-normal males received AL plus 0.25 (n = 10) or 0.40 mg/kg (n = 10) PQ. In The Gambia, G6PDd adult males and boys received DP alone (n = 10) or with 0.25 mg/kg PQ (n = 20); G6PD-normal males received DP plus 0.25 (n = 10) or 0.40 mg/kg (n = 10) PQ. The primary study endpoint was change in hemoglobin concentration during the 28-day follow-up. Cytochrome P-450 isoenzyme 2D6 (CYP2D6) metabolizer status, gametocyte carriage, haptoglobin, lactate dehydrogenase levels and reticulocyte counts were also determined. In Burkina Faso, the mean maximum absolute change in hemoglobin was -2.13 g/dL (95% confidence interval [CI], -2.78, -1.49) in G6PDd individuals randomized to 0.25 PQ mg/kg and -2.29 g/dL (95% CI, -2.79, -1.79) in those receiving 0.40 PQ mg/kg. In The Gambia, the mean maximum absolute change in hemoglobin concentration was -1.83 g/dL (95% CI, -2.19, -1.47) in G6PDd individuals receiving 0.25 PQ mg/kg. After adjustment for baseline concentrations, hemoglobin reductions in G6PDd individuals in Burkina Faso were more pronounced compared to those in G6PD-normal individuals receiving the same PQ doses (P = 0.062 and P = 0.022, respectively). Hemoglobin levels normalized during follow-up. Abnormal haptoglobin and lactate dehydrogenase levels provided additional evidence of mild transient hemolysis post-PQ. Conclusions: Single low-dose PQ in combination with AL and DP was associated with mild and transient reductions in hemoglobin. None of the study participants developed moderate or severe anemia; there were no severe adverse events. This indicates that single low-dose PQ is safe in G6PDd African males when used with artemisinin-based combination therapy. | |
dc.identifier | https://doi.org/10.5061/dryad.230ps | |
dc.identifier.uri | https://hydatakatalogi-test-24.it.helsinki.fi/handle/123456789/10260 | |
dc.rights | Open | |
dc.rights.license | cc-zero | |
dc.subject | Plasmodium falciparum | |
dc.subject | haemoglobin | |
dc.subject | primaquine | |
dc.subject | haemolysis | |
dc.subject | safety | |
dc.subject | gametocyte | |
dc.subject | reticulocytes | |
dc.subject | malaria | |
dc.title | Data from: Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: two open-label, randomized, safety trials | |
dc.type | dataset | |
dc.type | dataset |