Evidence map›Paper›PMID 35585641›Full record

Trial reportTrials2022

Reducing the risk of Plasmodium vivax after falciparum infections in co-endemic areas-a randomized controlled trial (PRIMA).

Kamala Thriemer, Tamiru Shibru Degaga, Michael Christian, Mohammad Shafiul Alam, Benedikt Ley, Mohammad Sharif Hossain, Mohammad Golam Kibria, Tedla Teferi Tego, Dagimawie Tadesse Abate, Sophie Weston and 13 more

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

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03916003 (Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

NCT03916003 phase4completednot on this map

Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial

TypeinterventionalSponsorMenzies School of Health ResearchRan2019 to 2022Enrolled500ConditionsMalaria, Vivax Malaria, Falciparum MalariaArmsprimaquine
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Characterizing the Blood-Stage Antimalarial Activity of Tafenoquine in Healthy Volunteers Experimentally Infected With Plasmodium falciparum.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  7. Article
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

23 authors at 9 institutions in 6 countries.

Kamala ThriemerGlobal and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia. kamala.ley-thriemer@menzies.edu.au.ORCID http://orcid.org/0000-0001-7536-7497
Tamiru Shibru DegagaCollege of Medicine & Health Sciences, Arba Minch University, Arba Minch, Ethiopia.
Michael ChristianEijkman-Oxford Clinical Research Unit, Jakarta, Indonesia.
Mohammad Shafiul AlamInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Benedikt LeyGlobal and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Mohammad Sharif HossainInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Mohammad Golam KibriaInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Tedla Teferi TegoArba Minch General Hospital, Arba Minch, Ethiopia.
Dagimawie Tadesse AbateCollege of Medicine & Health Sciences, Arba Minch University, Arba Minch, Ethiopia.
Sophie WestonGlobal and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Amalia KarahaliosCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
Megha RajasekharCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
Julie A SimpsonCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
Angela RumasebGlobal and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Hellen MnjalaGlobal and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Grant LeeGlobal and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Rodas Temesgen AnoseCollege of Medicine & Health Sciences, Arba Minch University, Arba Minch, Ethiopia.
Fitsum Getahun KidaneCollege of Medicine & Health Sciences, Arba Minch University, Arba Minch, Ethiopia.
Adugna WoyessaEthiopian Public Health Institute, Addis Ababa, Ethiopia.
Kevin BairdEijkman-Oxford Clinical Research Unit, Jakarta, Indonesia.
Inge SutantoDepartment of Parasitology, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.
Asrat HailuCollege of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Ric N PriceGlobal and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Charles Darwin University · AUArba Minch University · ETInternational Centre for Diarrhoeal Disease Research · BDThe University of Melbourne · AUEijkman Institute for Molecular Biology · IDAddis Ababa University · ETEthiopian Public Health Institute · ETMahidol University · THUniversity of Indonesia · ID

Funding

Australian Academy of Science Regional Collaborations ProgramGates Foundation INV-010504National Health and Medical Research Council APP1132975Wellcome Trust 200909/Z/16/Z
6 · The paper itself

Abstract

backgroundPlasmodium vivax forms dormant liver stages that can reactivate weeks or months following an acute infection. Recurrent infections are often associated with a febrile illness and can cause a cumulative risk of severe anaemia, direct and indirect mortality, and onward transmission of the parasite. There is an increased risk of P. vivax parasitaemia following falciparum malaria suggesting a rationale for universal use of radically curative treatment in patients with P. falciparum malaria even in the absence of detectable P. vivax parasitaemia in areas that are co-endemic for both species.

methodsThis is a multicentre, health care facility-based, randomized, controlled, open-label trial in Bangladesh, Indonesia and Ethiopia. Patients with uncomplicated falciparum malaria, G6PD activity of ≥70% of the adjusted male median (AMM) and haemoglobin levels ≥8g/dl are recruited into the study and randomized to either receive standard schizonticidal treatment plus 7-day high dose primaquine (total dose 7mg/kg) or standard care in a 1:1 ratio. Patients are followed up weekly until day 63. The primary endpoint is the incidence risk of any P. vivax parasitemia on day 63. Secondary endpoints include incidence risk on day 63 of symptomatic P. vivax malaria and the risk of any P. falciparum parasitaemia. Secondary safety outcomes include the proportion of adverse events and serious adverse events, the incidence risk of severe anaemia (Hb<5g/dl and <7g/dl) and/or the risk for blood transfusion, the incidence risk of ≥ 25% fall in haemoglobin with and without haemoglobinuria, and the incidence risk of ≥ 25% fall in haemoglobin to under 7g/dl with and without haemoglobinuria. DISCUSSION: This study evaluates the potential benefit of a universal radical cure for both P. vivax and P. falciparum in different endemic locations. If found safe and effective universal radical cure could represent a cost-effective approach to clear otherwise unrecognised P. vivax infections and hence accelerate P. vivax elimination.

trial registrationNCT03916003 . Registered on 12 April 2019.

Indexed as

AntimalarialsMalariaMalaria, FalciparumMalaria, VivaxHemoglobinuriaHumansMalePlasmodium falciparumPlasmodium vivaxPrimaquineAntimalarialsPrimaquineCo-endemicFalciparum malariaRadical cureRandomized controlled trialUniversal radical cureVivax eliminationVivax malaria

Identifiers

PMID35585641
PMCPMC9116071
OpenAlexW4280490350

What OpenQuestion holds

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LicenceCC BY
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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.