Evidence map›Paper›PMID 29342267›Full record

ArticleThe Journal of infectious diseases2018

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

Ingrid Chen, Halimatou Diawara, Almahamoudou Mahamar, Koualy Sanogo, Sekouba Keita, Daouda Kone, Kalifa Diarra, Moussa Djimde, Mohamed Keita, Joelle Brown and 9 more

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02535767 (Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02535767 phase1 / phase2completednot on this map

Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali

TypeinterventionalSponsorUniversity of California, San FranciscoRan2015 to 2016Enrolled28ConditionsMalariaArmsPrimaquine
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 5 countries.

Ingrid ChenMalaria Elimination Initiative, Global Health Group, San Francisco.
Halimatou DiawaraMalaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako.
Almahamoudou MahamarMalaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako.
Koualy SanogoMalaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako.
Sekouba KeitaMalaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako.
Daouda KoneMalaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako.
Kalifa DiarraMalaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako.
Moussa DjimdeMalaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako.
Mohamed KeitaNational University Hospital of Point G, Bamako, Mali.
Joelle BrownDepartment of Epidemiology and Biostatistics, San Francisco.
Michelle E RohMalaria Elimination Initiative, Global Health Group, San Francisco.
Jimee HwangMalaria Elimination Initiative, Global Health Group, San Francisco.
Helmi PettDepartment of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Maxwell MurphySchool of Medicine, University of California, San Francisco.
Mikko NiemiDepartment of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Finland.
Bryan GreenhouseSchool of Medicine, University of California, San Francisco.
Teun BousemaDepartment of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Roly GoslingMalaria Elimination Initiative, Global Health Group, San Francisco.
Alassane DickoMalaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako.
Université des Sciences, des Techniques et des Technologies de Bamako · MLUniversity of California, San Francisco · USUniversity of Helsinki · FICenters for Disease Control and Prevention · USRadboud University Medical Center · NLUniversity of Bamako · ML

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdolescentAdultAgingAntimalarialsChildChild, PreschoolDose-Response Relationship, DrugGlucosephosphate Dehydrogenase DeficiencyHemoglobinsHumansMaleMaliMiddle AgedPrimaquineYoung AdultAntimalarialsHemoglobinsPrimaquine

Identifiers

PMID29342267
PMCPMC5974787
OpenAlexW2782587633

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.