Evidence map›Paper›PMID 37813539›Full record

ArticleBMJ open2023

Efficacy and safety of pyronaridine-artesunate (PYRAMAX) for the treatment of

Moussa Djimde, Japhet Kabalu Tshiongo, Hypolite Mavoko Muhindo, Halidou Tinto, Esperanca Sevene, Maminata Traore, Anifa Vala, Salesio Macuacua, Berenger Kabore, Edgard Diniba Dabira and 12 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.9field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. 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

22 authors at 10 institutions in 11 countries.

Moussa Djimde *Malaria Research and Training Center, University of Sciences Techniques and Technologies of Bamako, Bamako, Mali.
Japhet Kabalu Tshiongo *Département of Tropical Médecine, Universite de Kinshasa, Kinshasa, Democratic Republic of Congo.ORCID 0000-0002-2344-1111
Hypolite Mavoko MuhindoDepartment of Tropical Medicine, Universite de Kinshasa Faculte de Medecine, Kinshasa, Democratic Republic of Congo.
Halidou TintoInstitut de Recherche en Sciences de la Santé (IRSS) - Unité de Recherche Clinique de Nanoro, Nanoro, Burkina Faso.
Esperanca SeveneCentro de Investigacao em Saude de Manhica, Manhica, Mozambique.
Maminata TraoreInstitut de Recherche en Sciences de la Santé (IRSS) - Unité de Recherche Clinique de Nanoro, Ouagadougou, Burkina Faso.
Anifa ValaCentro de Investigação em Saúde de Manhiça, Manhica, Mozambique.
Salesio MacuacuaCentro de Investigação em Saúde da Manhiça (CISM), Maputo, Mozambique.
Berenger KaboreInstitut de Recherche en Sciences de la Santé (IRSS) - Unité de Recherche Clinique de Nanoro, Ouagadougou, Burkina Faso.
Edgard Diniba DabiraMRC Unit The Gambia (MRCG) at the London School of Hygiene and Tropical Medicine, The Gambia London, UK.
Annette ErhartMRC Unit The Gambia (MRCG) at the London School of Hygiene and Tropical Medicine, The Gambia London, UK.
Hamadoun DiakiteMalaria Research and Training Center, University of Sciences Techniques and Technologies of Bamako, Bamako, Mali.
Mohamed KeitaFaculty of Medicine Odontostomatology, University of Sciences Techniques and Technologies of Bamako, Bamako, Mali.
Mireia PiquerasInstituto de Salud Global Barcelona, Barcelona, Spain.
Raquel GonzálezInstituto de Salud Global Barcelona, Barcelona, Spain.ORCID 0000-0001-5487-801X
Clara MenendezInstituto de Salud Global Barcelona, Barcelona, Spain.
Thomas Pc DorloNetherlands Cancer Institute / Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Issaka SagaraMalaria Research and Training Center, University of Sciences Techniques and Technologies of Bamako, Bamako, Mali.
Petra MensAmsterdam University Medical Centres, Academic Medical Centre at the University of Amsterdam (AMC), Amsterdam, The Netherlands.
Henk SchalligAmsterdam University Medical Centres, Academic Medical Centre at the University of Amsterdam (AMC), Amsterdam, The Netherlands.
Umberto D'AlessandroMRC Laboratories The Gambia, Banjul, Gambia.
Kassoum KayentaoMalaria Research and Training Center, University of Sciences Techniques and Technologies of Bamako, Bamako, Mali kayentao@icermali.org.ORCID 0000-0001-6877-0093
Université des Sciences, des Techniques et des Technologies de Bamako · MLBarcelona Institute for Global Health · ESInstitut de Recherche en Sciences de la Santé · BFLondon School of Hygiene & Tropical Medicine · GBManhiça Health Research Centre · MZUniversity of Amsterdam · NLUniversity of Kinshasa · CDEduardo Mondlane University · MZMRC Unit the Gambia · GMUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMalaria infection during pregnancy increases the risk of low birth weight and infant mortality and should be prevented and treated. Artemisinin-based combination treatments are generally well tolerated, safe and effective; the most used being artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP). Pyronaridine-artesunate (PA) is a new artemisinin-based combination. The main objective of this study is to determine the efficacy and safety of PA versus AL or DP when administered to pregnant women with confirmed METHODS AND ANALYSIS: A phase 3, non-inferiority, randomised, open-label clinical trial to determine the safety and efficacy of AL, DP and PA in pregnant women with malaria in five sub-Saharan, malaria-endemic countries (Burkina Faso, Democratic Republic of the Congo, Mali, Mozambique and the Gambia). A total of 1875 pregnant women will be randomised to one of the treatment arms. Women will be actively monitored until Day 63 post-treatment, at delivery and 4-6 weeks after delivery, and infants' health will be checked on their first birthday. The primary endpoint is the PCR-adjusted rate of adequate clinical and parasitological response at Day 42 in the per-protocol population. ETHICS AND DISSEMINATION: This protocol has been approved by the Ethics Committee for Health Research in Burkina Faso, the National Health Ethics Committee in the Democratic Republic of Congo, the Ethics Committee of the Faculty of Medicine and Odontostomatology/Faculty of Pharmacy in Mali, the Gambia Government/MRCG Joint Ethics Committee and the National Bioethics Committee for Health in Mozambique. Written informed consent will be obtained from each individual prior to her participation in the study. The results will be published in peer-reviewed open access journals and presented at (inter)national conferences and meetings. TRIAL REGISTRATION NUMBER: PACTR202011812241529.

Indexed as

AntimalarialsArtemisininsMalariaMalaria, FalciparumArtemetherArtemether, Lumefantrine Drug CombinationArtesunateClinical Trials, Phase III as TopicDrug CombinationsEquivalence Trials as TopicFemaleHumansInfantNaphthyridinesPregnancyPregnant PeopleAntimalarialsArtemetherArtemether, Lumefantrine Drug CombinationartemisininArtemisininsartenimolArtesunateDrug CombinationsNaphthyridinespyronaridine tetraphosphate, artesunate drug combinationepidemiologyinfection controlparasitologytropical medicine

Identifiers

PMID37813539
PMCPMC10565244
OpenAlexW4387450760

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.