Evidence map›Paper›PMID 26952094›Full record

Trial reportBMC medicine2016

Single low dose primaquine to reduce gametocyte carriage and Plasmodium falciparum transmission after artemether-lumefantrine in children with asymptomatic infection: a randomised, double-blind, placebo-controlled trial.

Bronner P Gonçalves, Alfred B Tiono, Alphonse Ouédraogo, Wamdaogo M Guelbéogo, John Bradley, Issa Nebie, Débé Siaka, Kjerstin Lanke, Alice C Eziefula, Amidou Diarra and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01935882 (A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of Low Dose Primaquine for Clearance of Gametocytes in Asymptomatic Individuals Infected With P. Falciparum in Burkina Faso), which is not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01935882 phase2 / phase3completednot on this map

A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of Low Dose Primaquine for Clearance of Gametocytes in Asymptomatic Individuals Infected With P. Falciparum in Burkina Faso

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2013 to 2015Enrolled360ConditionsMalaria, Asymptomatic Malaria, Plasmodium FalciparumArmsArtemether-lumefantrine combination, Artemether-Lumefantrine with a single dose of 0.25mg/kg primaquine, Artemether-Lumefantrine with a single dose of 0.4mg/kg primaquine
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Efficacy, Safety and Tolerability of Pyronaridine-artesunate in Asymptomatic Malaria-infected Individuals: a Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
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  8. Antimicrobial agents and chemotherapy · 2019
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  16. Molecular Markers for Sensitive Detection ofThe American journal of tropical medicine and hygiene · 2017
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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

15 authors.

Bronner P GonçalvesDepartment of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK. bronner.goncalves@lshtm.ac.uk.
Alfred B TionoDepartment of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso. vtalfred@fasonet.bf.
Alphonse OuédraogoDepartment of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso. aouedraogo.cnrfp@fasonet.bf.
Wamdaogo M GuelbéogoDepartment of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso. guelbeogo.cnrfp@fasonet.bf.
John BradleyMRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK. john.bradley@lshtm.ac.uk.
Issa NebieDepartment of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso. issanebie.cnlp@fasonet.bf.
Débé SiakaDepartment of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso. vs.debe.cnrfp@fasonet.bf.
Kjerstin LankeDepartment of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands. kjerstin.lanke@radboudumc.nl.
Alice C EziefulaDepartment of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK. chi.eziefula@googlemail.com.
Amidou DiarraDepartment of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso. a.diarra.cnrfp@fasonet.bf.
Helmi PettDepartment of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands. helmi.pett@radboudumc.nl.
Edith C BougoumaDepartment of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso. veddy.cnrfp@fasonet.bf.
Sodiomon B SirimaDepartment of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso. s.sirima.cnlp@fasonet.bf.
Chris DrakeleyDepartment of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK. chris.drakeley@lshtm.ac.uk.
Teun BousemaDepartment of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands. teun.bousema@radboudumc.nl.

Funding

European Research Council 639776Medical Research Council MR/K012126/1
6 · The paper itself

Abstract

backgroundA single low dose (0.25 mg/kg) of primaquine is recommended as a gametocytocide in combination with artemisinin-based combination therapies for Plasmodium falciparum but its effect on post-treatment gametocyte circulation and infectiousness to mosquitoes has not been quantified.

methodsIn this randomised, double-blind, placebo-controlled trial, 360 asymptomatic parasitaemic children aged 2-15 years were enrolled and assigned to receive: artemether-lumefantrine (AL) and a dose of placebo; AL and a 0.25 mg/kg primaquine dose; or AL and a 0.40 mg/kg primaquine dose. On days 0, 2, 3, 7, 10 and 14, gametocytes were detected and quantified by microscopy, Pfs25 mRNA quantitative nucleic acid sequence based amplification (QT-NASBA), and quantitative reverse-transcriptase PCR (qRT-PCR). For a subset of participants, pre- and post-treatment infectiousness was assessed by mosquito feeding assays on days -1, 3, 7, 10 and 14.

resultsBoth primaquine arms had lower gametocyte prevalences after day 3 compared to the placebo arm, regardless of gametocyte detection method. The mean (95% confidence interval) number of days to gametocyte clearance in children with patent gametocytes on day 0 (N = 150) was 19.7 (14.6 - 24.8), 7.7 (6.3 - 9.1) and 8.2 (6.7 - 9.6) for the AL-placebo, the 0.25 mg/kg primaquine dose and the 0.40 mg/kg primaquine dose arms, respectively. While 38.0% (30/79) of selected gametocytaemic individuals were infectious before treatment, only 1/251 participant, from the AL-placebo group, infected mosquitoes after treatment.

conclusionsWe observed similar gametocyte clearance rates after 0.25 and 0.40 mg/kg primaquine doses. Infectivity to mosquitoes after AL was very low and absent in primaquine arms. CLINICALTRIALS. GOV REGISTRATION: NCT01935882.

Indexed as

AntimalarialsArtemetherArtemisininsAsymptomatic InfectionsChildChild, PreschoolDouble-Blind MethodDrug Therapy, CombinationEthanolaminesFemaleFluorenesHumansInfantLumefantrineMalaria, FalciparumMaleAntimalarialsArtemetherArtemisininsEthanolaminesFluorenesLumefantrinePrimaquine

Identifiers

PMID26952094
PMCPMC4782330

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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.