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Data from: Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: two open-label, randomized, safety trials

Bastiaens, Guido; Tiono, Alfred B.; Okebe, Joseph; Pett, Helmi; Coulibaly, Sam A.; Gonçalves, Bronner P.; Affara, Muna; Ouédraogo, Alphonse; Bougouma, Edith C.; Sanou, Guillaume S.; Nébié, Issa; Bradley, John; Lanke, Kjerstin H. W.; Niemi, Mikko; Sirima, Sodiomon B.; d'Alessandro, Umberto; Bousema, Teun; Drakeley, Chris; Bastiaens, Guido J. H.; Pett, Helmi E.; d'Alessandro, Umberto


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    "doi": "10.5061/dryad.230ps", 
    "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.", 
    "license": {
      "id": "CC0-1.0"
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    "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", 
    "notes": "<div class=\"o-metadata__file-usage-entry\">SAFEPRIM Burkina Faso Adverse Events<div class=\"o-metadata__file-description\">Adverse events SAFEPRIM trial Burkina Faso</div><div class=\"o-metadata__file-name\">DRYAD_SAFEPRIM Burkina Faso Adverse Events.xlsx<br></div></div><div class=\"o-metadata__file-usage-entry\">SAFEPRIM Gambia Adverse Events<div class=\"o-metadata__file-description\">Adverse events SAFEPRIM trial The Gambia</div><div class=\"o-metadata__file-name\">DRYAD_SAFEPRIM Gambia Adverse Events.xlsx<br></div></div><div class=\"o-metadata__file-usage-entry\">DRYAD SAFEPRIM main dataset Burkina Faso<div class=\"o-metadata__file-description\">Laboratory results from clinical trial in Burkina Faso. Data include haemoglobin concentration, reticulocyte counts, full haematology and biochemistry.</div><div class=\"o-metadata__file-name\"></div></div><div class=\"o-metadata__file-usage-entry\">DRYAD SAFEPRIM main dataset The Gambia<div class=\"o-metadata__file-description\">Laboratory results from clinical trial in The Gambia. Data include haemoglobin concentration, reticulocyte counts, full haematology and biochemistry.</div><div class=\"o-metadata__file-name\"></div></div><p>Funding provided by: National Science Foundation<br>Crossref Funder Registry ID: http://dx.doi.org/10.13039/100000001<br>Award Number: BMGF OPP1034789</p>", 
    "locations": [
      {
        "place": "The Gambia"
      }, 
      {
        "place": "Burkina Faso"
      }
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      {
        "id": "dryad"
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    ], 
    "keywords": [
      "Plasmodium falciparum", 
      "haemoglobin", 
      "primaquine", 
      "haemolysis", 
      "safety", 
      "gametocyte", 
      "reticulocytes", 
      "malaria"
    ], 
    "publication_date": "2018-12-18", 
    "creators": [
      {
        "name": "Bastiaens, Guido"
      }, 
      {
        "name": "Tiono, Alfred B."
      }, 
      {
        "affiliation": "Medical Research Council", 
        "name": "Okebe, Joseph"
      }, 
      {
        "name": "Pett, Helmi"
      }, 
      {
        "name": "Coulibaly, Sam A."
      }, 
      {
        "name": "Gon\u00e7alves, Bronner P."
      }, 
      {
        "affiliation": "Medical Research Council", 
        "name": "Affara, Muna"
      }, 
      {
        "name": "Ou\u00e9draogo, Alphonse"
      }, 
      {
        "name": "Bougouma, Edith C."
      }, 
      {
        "name": "Sanou, Guillaume S."
      }, 
      {
        "name": "N\u00e9bi\u00e9, Issa"
      }, 
      {
        "affiliation": "London School of Hygiene & Tropical Medicine", 
        "name": "Bradley, John"
      }, 
      {
        "affiliation": "Radboud University Nijmegen", 
        "name": "Lanke, Kjerstin H. W."
      }, 
      {
        "affiliation": "University of Helsinki", 
        "name": "Niemi, Mikko"
      }, 
      {
        "name": "Sirima, Sodiomon B."
      }, 
      {
        "name": "d'Alessandro, Umberto"
      }, 
      {
        "affiliation": "Radboud University Nijmegen", 
        "name": "Bousema, Teun"
      }, 
      {
        "name": "Drakeley, Chris"
      }, 
      {
        "affiliation": "Radboud University Nijmegen", 
        "name": "Bastiaens, Guido J. H."
      }, 
      {
        "affiliation": "University of Helsinki", 
        "name": "Pett, Helmi E."
      }, 
      {
        "affiliation": "Medical Research Council", 
        "name": "d'Alessandro, Umberto"
      }
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