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

Abstract 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.
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Mayor MeshTerms
Keywords
Journal Title plos one
Publication Year Start




PMID- 29324864
OWN - NLM
STAT- MEDLINE
DCOM- 20180206
LR  - 20180207
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 13
IP  - 1
DP  - 2018
TI  - Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase
      deficient falciparum-infected African males: Two open-label, randomized, safety
      trials.
PG  - e0190272
LID - 10.1371/journal.pone.0190272 [doi]
AB  - 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. TRIAL REGISTRATION: Clinicaltrials.gov
      NCT02174900 Clinicaltrials.gov NCT02654730.
FAU - Bastiaens, Guido J H
AU  - Bastiaens GJH
AUID- ORCID: 0000-0002-8198-662X
AD  - Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, 
      the Netherlands.
FAU - Tiono, Alfred B
AU  - Tiono AB
AD  - Department of Biomedical Sciences, Centre National de Recherche et de Formation
      sur le Paludisme, Ouagadougou, Burkina Faso.
FAU - Okebe, Joseph
AU  - Okebe J
AD  - Disease Control & Elimination Theme, Medical Research Council Unit, Fajara, The
      Gambia.
FAU - Pett, Helmi E
AU  - Pett HE
AD  - Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, 
      the Netherlands.
AD  - Department of Clinical Pharmacology, University of Helsinki and Helsinki
      University Hospital, Helsinki, Finland.
FAU - Coulibaly, Sam A
AU  - Coulibaly SA
AD  - Department of Biomedical Sciences, Centre National de Recherche et de Formation
      sur le Paludisme, Ouagadougou, Burkina Faso.
FAU - Goncalves, Bronner P
AU  - Goncalves BP
AD  - Department of Immunology and Infection, London School of Hygiene and Tropical
      Medicine, London, United Kingdom.
FAU - Affara, Muna
AU  - Affara M
AD  - Disease Control & Elimination Theme, Medical Research Council Unit, Fajara, The
      Gambia.
FAU - Ouedraogo, Alphonse
AU  - Ouedraogo A
AD  - Department of Biomedical Sciences, Centre National de Recherche et de Formation
      sur le Paludisme, Ouagadougou, Burkina Faso.
FAU - Bougouma, Edith C
AU  - Bougouma EC
AD  - Department of Biomedical Sciences, Centre National de Recherche et de Formation
      sur le Paludisme, Ouagadougou, Burkina Faso.
FAU - Sanou, Guillaume S
AU  - Sanou GS
AD  - Department of Biomedical Sciences, Centre National de Recherche et de Formation
      sur le Paludisme, Ouagadougou, Burkina Faso.
FAU - Nebie, Issa
AU  - Nebie I
AD  - Department of Biomedical Sciences, Centre National de Recherche et de Formation
      sur le Paludisme, Ouagadougou, Burkina Faso.
FAU - Bradley, John
AU  - Bradley J
AD  - MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine,
      London, United Kingdom.
FAU - Lanke, Kjerstin H W
AU  - Lanke KHW
AD  - Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, 
      the Netherlands.
FAU - Niemi, Mikko
AU  - Niemi M
AD  - Department of Clinical Pharmacology, University of Helsinki and Helsinki
      University Hospital, Helsinki, Finland.
FAU - Sirima, Sodiomon B
AU  - Sirima SB
AD  - Department of Biomedical Sciences, Centre National de Recherche et de Formation
      sur le Paludisme, Ouagadougou, Burkina Faso.
FAU - d'Alessandro, Umberto
AU  - d'Alessandro U
AD  - Disease Control & Elimination Theme, Medical Research Council Unit, Fajara, The
      Gambia.
AD  - Department of Disease Control, Faculty of infectious and Tropical Diseases,
      London School of Hygiene and Tropical Medicine, London, United Kingdom.
FAU - Bousema, Teun
AU  - Bousema T
AD  - Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, 
      the Netherlands.
AD  - Department of Immunology and Infection, London School of Hygiene and Tropical
      Medicine, London, United Kingdom.
FAU - Drakeley, Chris
AU  - Drakeley C
AD  - Department of Immunology and Infection, London School of Hygiene and Tropical
      Medicine, London, United Kingdom.
LA  - eng
SI  - Dryad/10.5061/dryad.230ps
SI  - ClinicalTrials.gov/NCT02174900
SI  - ClinicalTrials.gov/NCT02654730
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180111
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antimalarials)
RN  - EC 1.1.1.49 (Glucosephosphate Dehydrogenase)
RN  - MVR3634GX1 (Primaquine)
SB  - IM
MH  - Adult
MH  - Antimalarials/*administration & dosage/adverse effects
MH  - Burkina Faso
MH  - Glucosephosphate Dehydrogenase/*genetics
MH  - Humans
MH  - Malaria, Falciparum/*drug therapy
MH  - Male
MH  - Primaquine/*administration & dosage/adverse effects
MH  - Young Adult
PMC - PMC5764271
EDAT- 2018/01/13 06:00
MHDA- 2018/02/07 06:00
CRDT- 2018/01/12 06:00
PHST- 2017/08/22 00:00 [received]
PHST- 2017/12/05 00:00 [accepted]
PHST- 2018/01/12 06:00 [entrez]
PHST- 2018/01/13 06:00 [pubmed]
PHST- 2018/02/07 06:00 [medline]
AID - 10.1371/journal.pone.0190272 [doi]
AID - PONE-D-17-23921 [pii]
PST - epublish
SO  - PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272.
      eCollection 2018.