Evidence map›Paper›PMID 25887344›Full record

Trial reportTrials2015

The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial.

Joseph Okebe, Teun Bousema, Muna Affara, GianLuca DiTanna, Alice C Eziefula, Musa Jawara, Davis Nwakanma, Alfred Amambua-Ngwa, Jean-Pierre Van Geertruyden, Chris Drakeley and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01838902 (Primaquine's Gametocytocidal Efficacy in Malaria Asymptomatic Carriers Treated With Dihydroartemisinin-piperaquine in The Gambia), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% 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.

NCT01838902 phase3completednot on this map

Primaquine's Gametocytocidal Efficacy in Malaria Asymptomatic Carriers Treated With Dihydroartemisinin-piperaquine in The Gambia

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2013 to 2015Enrolled467ConditionsMalariaArmsDHA-PPQ, PQ (0.75), PQ (0.4), PQ (0.2)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
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  5. Article
  6. Age, Weight, andAntimicrobial agents and chemotherapy · 2017
    Article
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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

11 authors at 3 institutions in 3 countries.

Joseph OkebeDisease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia. jokebe@mrc.gm.
Teun BousemaImmunology and Infection Department, London School of Hygiene and Tropical Medicine, London, UK. teun.Bousema@lshtm.ac.uk.
Muna AffaraDisease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia. maffara@mrc.gm.
GianLuca DiTannaDepartment of Infectious Disease Epidemiology, Faculty of Epidemiology and Population health, London School of Hygiene and Tropical Medicine, London, UK. GianLuca.DiTanna@lshtm.ac.uk.
Alice C EziefulaImmunology and Infection Department, London School of Hygiene and Tropical Medicine, London, UK. chi.eziefula@lshtm.ac.uk.
Musa JawaraDisease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia. mjawara@mrc.gm.
Davis NwakanmaDisease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia. dnwakanma@mrc.gm.
Alfred Amambua-NgwaDisease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia. angwa@mrc.gm.
Jean-Pierre Van GeertruydenInternational Health Unit, Faculty of Medicine & Health Sciences, University of Antwerp, Antwerp, Belgium. Jean-Pierre.VanGeertruyden@ua.ac.be.
Chris DrakeleyImmunology and Infection Department, London School of Hygiene and Tropical Medicine, London, UK. Chris.Drakeley@lshtm.ac.uk.
Umberto D'AlessandroDisease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia. udalessandro@mrc.gm.
London School of Hygiene & Tropical Medicine · GBMRC Unit the Gambia · GMUniversity of Antwerp · BE

Funding

Medical Research Council MC_EX_MR/K007203/1Medical Research Council MC_EX_MR/K02440X/1Medical Research Council MR/K012126/1Wellcome Trust 100714
6 · The paper itself

Abstract

backgroundFinding efficacious tools to decrease and interrupt malaria transmission is essential to sustain the gains in malaria control and contain the emergence of artemisinin resistance. Primaquine is effective against Plasmodium falciparum gametocytes and recommended for treatment campaigns in (pre-)elimination settings. Safety concerns preclude its use in endemic African countries with variable proportions of glucose-6-phosphate dehydrogenase (G6PD)-deficient individuals. The efficacy of the current recommended dose needs to be evaluated, particularly in individuals with an asymptomatic malaria infection. METHODS/

designThis is a four-arm, open label, randomized controlled trial that aims to determine and compare the effect of three different single doses of primaquine combined with dihydroartemisinin-piperaquine, an artemisinin-based combination therapy, on gametocyte carriage in asymptomatic, malaria infected, G6PD-normal individuals. Approximately 1,200 participants are enrolled and followed for 42 days, with the primary endpoint being the prevalence of Plasmodium falciparum gametocyte carriage at day 7 of follow-up determined by quantitative nucleic acid sequence based amplification assay. Direct membrane feeding experiments to determine infectiousness to mosquitoes are conducted as a biological secondary endpoint. DISCUSSION: Sub-Saharan Africa, with a relatively high but poorly characterized G6PD prevalence, could potentially benefit from the use of primaquine to further reduce or interrupt malaria transmission. However, G6PD screening may not be feasible given the cost and difficulties in interpreting test results in terms of risk of haemolysis. Because the haemolytic effect of primaquine is dose-dependent, determining the minimal gametocytocidal and transmission-blocking dose of primaquine is extremely important to help address public health concerns over its safety and validate the efficacy of lower than recommended dosages. By including infectiousness to mosquitoes, the trial provides complementary evidence for the potential of the drug to interrupt transmission to mosquitoes.

trial registrationClinicalTrials.gov: NCT01838902 (12 April 2013).

Indexed as

Clinical ProtocolsAntimalarialsArtemisininsData Interpretation, StatisticalDrug CombinationsHumansPiperazinesPlasmodium falciparumPrimaquineQuinolinesSample SizeAntimalarialsArtemisininsartenimolDrug CombinationspiperaquinePiperazinesPrimaquineQuinolines

Identifiers

PMID25887344
PMCPMC4349754
OpenAlexW2152428242

What OpenQuestion holds

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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.