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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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{
  "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": "https://creativecommons.org/publicdomain/zero/1.0/legalcode", 
  "creator": [
    {
      "@type": "Person", 
      "name": "Bastiaens, Guido"
    }, 
    {
      "@type": "Person", 
      "name": "Tiono, Alfred B."
    }, 
    {
      "affiliation": "Medical Research Council", 
      "@type": "Person", 
      "name": "Okebe, Joseph"
    }, 
    {
      "@type": "Person", 
      "name": "Pett, Helmi"
    }, 
    {
      "@type": "Person", 
      "name": "Coulibaly, Sam A."
    }, 
    {
      "@type": "Person", 
      "name": "Gon\u00e7alves, Bronner P."
    }, 
    {
      "affiliation": "Medical Research Council", 
      "@type": "Person", 
      "name": "Affara, Muna"
    }, 
    {
      "@type": "Person", 
      "name": "Ou\u00e9draogo, Alphonse"
    }, 
    {
      "@type": "Person", 
      "name": "Bougouma, Edith C."
    }, 
    {
      "@type": "Person", 
      "name": "Sanou, Guillaume S."
    }, 
    {
      "@type": "Person", 
      "name": "N\u00e9bi\u00e9, Issa"
    }, 
    {
      "affiliation": "London School of Hygiene & Tropical Medicine", 
      "@type": "Person", 
      "name": "Bradley, John"
    }, 
    {
      "affiliation": "Radboud University Nijmegen", 
      "@type": "Person", 
      "name": "Lanke, Kjerstin H. W."
    }, 
    {
      "affiliation": "University of Helsinki", 
      "@type": "Person", 
      "name": "Niemi, Mikko"
    }, 
    {
      "@type": "Person", 
      "name": "Sirima, Sodiomon B."
    }, 
    {
      "@type": "Person", 
      "name": "d'Alessandro, Umberto"
    }, 
    {
      "affiliation": "Radboud University Nijmegen", 
      "@type": "Person", 
      "name": "Bousema, Teun"
    }, 
    {
      "@type": "Person", 
      "name": "Drakeley, Chris"
    }, 
    {
      "affiliation": "Radboud University Nijmegen", 
      "@type": "Person", 
      "name": "Bastiaens, Guido J. H."
    }, 
    {
      "affiliation": "University of Helsinki", 
      "@type": "Person", 
      "name": "Pett, Helmi E."
    }, 
    {
      "affiliation": "Medical Research Council", 
      "@type": "Person", 
      "name": "d'Alessandro, Umberto"
    }
  ], 
  "url": "https://zenodo.org/record/4988492", 
  "datePublished": "2018-12-18", 
  "spatial": [
    {
      "@type": "Place", 
      "name": "The Gambia"
    }, 
    {
      "@type": "Place", 
      "name": "Burkina Faso"
    }
  ], 
  "keywords": [
    "Plasmodium falciparum", 
    "haemoglobin", 
    "primaquine", 
    "haemolysis", 
    "safety", 
    "gametocyte", 
    "reticulocytes", 
    "malaria"
  ], 
  "@context": "https://schema.org/", 
  "distribution": [
    {
      "contentUrl": "https://zenodo.org/api/files/20d65667-0209-486b-a632-0c358466f6ac/DRYAD_SAFEPRIM Burkina Faso Adverse Events.xlsx", 
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      "@type": "DataDownload"
    }, 
    {
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    }, 
    {
      "contentUrl": "https://zenodo.org/api/files/20d65667-0209-486b-a632-0c358466f6ac/DRYAD SAFEPRIM main dataset Burkina Faso.xlsx", 
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    }, 
    {
      "contentUrl": "https://zenodo.org/api/files/20d65667-0209-486b-a632-0c358466f6ac/DRYAD SAFEPRIM main dataset The Gambia.xlsx", 
      "encodingFormat": "xlsx", 
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    }
  ], 
  "identifier": "https://doi.org/10.5061/dryad.230ps", 
  "@id": "https://doi.org/10.5061/dryad.230ps", 
  "@type": "Dataset", 
  "name": "Data from: Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: two open-label, randomized, safety trials"
}
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