Evidence map›Paper›PMID 20194698›Full record

Trial reportAntimicrobial agents and chemotherapy2010

In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals.

Seif A Shekalaghe, Roel ter Braak, Modibo Daou, Reginald Kavishe, Wouter van den Bijllaardt, Sven van den Bosch, Jan B Koenderink, Adrian J F Luty, Christopher J M Whitty, Chris Drakeley and 2 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 74 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 10 pooled it
20.8field-weighted citation impact, top 1% 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.

NCT01365598 phase3completednot on this mapstarted 2011, after this paper: background citation

Evaluation of the Efficacy and Safety of Primaquine for Clearance of Gametocytes in Uncomplicated Falciparum Malaria in Uganda

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2011 to 2013Enrolled468ConditionsFalciparum MalariaArmsPrimaquine
NCT01743820 phase2completednot on this mapstarted 2013, after this paper: background citation

Phase 2a Dose Escalation Study of the Efficacy, Safety, and Pharmacokinetics of Low Dose Primaquine for Gametocytocidal Activity Against P. Falciparum in Sub-Saharan Africa and South East Asia

TypeinterventionalSponsorUniversity of California, San FranciscoRan2013 to 2014Enrolled81ConditionsMalariaArmsdihydroartemisinin-piperaquine, 0.125 mg/kg Primaquine, 0.5 mg/kg Primaquine, 0.25 mg/kg Primaquine, 0.0625 mg/kg Primaquine
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 10 syntheses or guidelines pooled it, 109 citations in OpenAlex.

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  2. Mass drug administration for malaria.The Cochrane database of systematic reviews · 2021
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  7. Mass drug administration for malaria.The Cochrane database of systematic reviews · 2013
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14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 4 countries.

Seif A ShekalagheDepartment of Medical Microbiology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.
Roel ter Braak
Modibo Daou
Reginald Kavishe
Wouter van den Bijllaardt
Sven van den Bosch
Jan B Koenderink
Adrian J F Luty
Christopher J M Whitty
Chris Drakeley
Robert W Sauerwein
Teun Bousema
Radboud University Medical Center · NLLondon School of Hygiene & Tropical Medicine · GBKilimanjaro Christian Medical Centre · TZRadboud University Nijmegen · NL

Funding

Wellcome Trust
6 · The paper itself

Abstract

The current interest in malaria elimination has led to a renewed interest in drugs that can be used for mass administration to minimize malaria transmission. Primaquine (PQ) is the only generally available drug with a strong activity against mature Plasmodium falciparum gametocytes, the parasite stage responsible for transmission. Despite concerns about PQ-induced hemolysis in glucose-6-phosphate dehydrogenase (G6PD)-deficient individuals, a single dose of PQ may be safe and efficacious in clearing gametocytes that persist after conventional treatment. As part of a mass drug intervention, we determined the hemolytic effect of sulfadoxine-pyrimethamine (SP) plus artesunate (AS) plus a single dose of primaquine (PQ; 0.75 mg/kg of body weight) in children aged 1 to 12 years. Children were randomized to receive SP+AS+PQ or placebo; those with a hemoglobin (Hb) level below 8 g/dl were excluded from receiving PQ and received SP+AS. The Hb concentration was significantly reduced 7 days after SP+AS+PQ treatment but not after placebo or SP+AS treatment. This reduction in Hb was most pronounced in G6PD-deficient (G6PD A-) individuals (-2.5 g/dl; 95% confidence interval [95% CI], -1.2 to -3.8 g/dl) but was also observed in heterozygotes (G6PD A) (-1.6 g/dl; 95% CI, -0.9 to -2.2 g/dl) and individuals with the wild-type genotype (G6PD B) (-0.5 g/dl; 95% CI, -0.4 to -0.6 g/dl). Moderate anemia (Hb level of <8 g/dl) was observed in 40% (6/15 individuals) of the G6PD A-, 11.1% (3/27 individuals) of the G6PD A, and 4.5% (18/399 individuals) of the G6PD B individuals; one case of severe anemia (Hb level of <5 g/dl) was observed. PQ may cause moderate anemia when coadministered with artemisinins, and excluding individuals based on G6PD status alone may not be sufficient to prevent PQ-induced hemolysis.

Indexed as

AnemiaAnti-Infective AgentsAntimalarialsArtemisininsArtesunateChildChild, PreschoolDrug CombinationsDrug Therapy, CombinationFollow-Up StudiesGlucosephosphate DehydrogenaseGlucosephosphate Dehydrogenase DeficiencyHemoglobinsHemolysisHumansInfantAnti-Infective AgentsAntimalarialsartemisininArtemisininsArtesunateDrug Combinationsfanasil, pyrimethamine drug combinationGlucosephosphate DehydrogenaseHemoglobinsPrimaquinePyrimethamineSulfadoxine

Identifiers

PMID20194698
PMCPMC2863610
OpenAlexW2139477348

What OpenQuestion holds

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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.