Evidence map›Paper›PMID 39985024›Full record

Trial reportMalaria journal2025

Intermittent screening using ultra-sensitive malaria rapid diagnostic test and treatment with pyronaridine-artesunate compared to standard preventive treatment with sulfadoxine-pyrimethamine for malaria prevention in pregnant women in Kinshasa, DRC.

Japhet Kabalu Tshiongo, Flory Luzolo Khote, Melissa Kabena, Hypolite Muhindo Mavoko, Thierry Kalonji-Mukendi, Landrine Luzolo, Henk D F H Schallig, Kassoum Kayentao, Petra F Mens, Pascal Lutumba and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
In one paragraph

Trial report in Malaria journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04783051 (Comparison of IST Using Ultra-sensitive Malaria Rapid Diagnostic Test and Pyronaridine - Artesunate - PYRAMAX®) to Standard IPT Sulfadoxine-pyrimethamine to Prevent Malaria in Pregnant Women Living in Endemic Areas), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT04783051 phase3completednot on this map

Comparison of IST Using Ultra-sensitive Malaria Rapid Diagnostic Test and Pyronaridine - Artesunate - PYRAMAX®) to Standard IPT Sulfadoxine-pyrimethamine to Prevent Malaria in Pregnant Women Living in Endemic Areas

TypeinterventionalSponsorUniversity of KinshasaRan2021 to 2022Enrolled250ConditionsMalaria in PregnancyArmsSulfadoxine pyrimethamine, Pyramax
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. Review
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.

Japhet Kabalu TshiongoDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa, Democratic Republic of the Congo. kabalujaphet@gmail.com.
Flory Luzolo KhoteDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa, Democratic Republic of the Congo.
Melissa KabenaDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa, Democratic Republic of the Congo.
Hypolite Muhindo MavokoDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa, Democratic Republic of the Congo.
Thierry Kalonji-MukendiProgramme National de Lutte Contre le Monkeypox et les Fièvres Hémorragiques Virales, Ministère de la Santé (PNLMPX-FHV), Kinshasa, Democratic Republic of the Congo.
Landrine LuzoloDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa, Democratic Republic of the Congo.
Henk D F H SchalligLaboratory for Experimental Parasitology, Department of Medical Microbiology and Infection Prevention, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
Kassoum KayentaoMalaria Research and Training Center (MRTC), University of Sciences of Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
Petra F MensLaboratory for Experimental Parasitology, Department of Medical Microbiology and Infection Prevention, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
Pascal LutumbaDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa, Democratic Republic of the Congo.
Halidou TintoInstitut de Recherche en Sciences de la Santé-Clinical Research Unit of Nanoro (IRSS-CRUN), Nanoro, Burkina Faso.
Vivi MaketaDepartment of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa, Democratic Republic of the Congo.

Funding

This project is a part of the EDCTP2 program supported by the European Union (Grant number TMA2019CDF-2699-ULTRAPYRAPREG) TMA2019CDF-2699-ULTRAPYRAPREG
6 · The paper itself

Abstract

backgroundThe declining effectiveness of Intermittent Preventive Treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP) due to the emergence of Plasmodium falciparum resistance highlights the need for alternative malaria prevention strategies in pregnant women. A novel approach was proposed: screening with an ultra-sensitive rapid diagnostic test and treating positive with pyronaridine-artesunate (ISTp-uRDT-PA). This trial compared the impact of both strategies on maternal malaria and anaemia, abortion, intrauterine death, birth weight, preterm delivery.

methodsThis non-inferiority trial, conducted in Kinshasa, enrolled pregnant women in their second and third trimesters. Participants in the IPTp-SP arm (n = 124) received SP at monthly antenatal visit as per guidelines, while those in the ISTp-uRDT-PA arm (n = 126) were screened monthly with an uRDT and treated with PA if positive. Primary outcomes included asymptomatic parasitaemia (uRDT positive without fever) or symptomatic parasitaemia (uRDT positive with fever or history of fever, and parasite density by microscopy during pregnancy.

resultsAsymptomatic parasitaemia by uRDT during pregnancy was similar in both arms (20.8% in IPTp-SP vs 21.0% in ISTp-uRDT-PA). At delivery, asymptomatic parasitaemia was 51% higher in ISTp-uRDT-PA arm compared to IPTp-SP (cRR = 1.51 [95% CI 0.76-3.00], p = 0.24). Symptomatic parasitaemia by uRDT at delivery showed no significant difference. Malaria by microscopy at enrolment was detected in 34.4% of women. Malaria by microscopy during pregnancy was 9.6% in IPTp-SP and 10.1%. ISTp-uRDT-PA (p = 0.19), decreasing to 3.2% and 0.9%, respectively, at delivery (p = 0.24). Mean haemoglobin concentration at enrolment was 10.1 g/dl in the IPTp-SP and 9.8 g/dl in the ISTp-uRDT-PA with no significant difference in maternal anaemia at delivery (7%; cRR = 1.07 [95% CI 0.87-1.31], p = 0.52). No significant differences were found for spontaneous abortions and in utero death in both arms. The risk of a premature newborn declined by 14% in ISTp-uRDT-PA compared to the IPTp-SP arm (cRR = 0.86 [95% CI 0.29-2.85], p = 0.79) while low-birth-weight was not significantly higher (cRR = 1.74 [95% CI 0.86-3.53], p = 0.12).

conclusionISTp-uRDT-PA was non inferior to IPTp-SP and can be considered as a future alternative for IPTp-SP in case this intervention can no longer be used due to high SP resistance. CLINICAL TRIALS REGISTRATION: NCT04783051.

Indexed as

AntimalarialsArtesunateDiagnostic Tests, RoutineMalaria, FalciparumNaphthyridinesPregnancy Complications, ParasiticPyrimethamineSulfadoxineAdolescentAdultDemocratic Republic of the CongoDrug CombinationsFemaleHumansPregnancyRapid Diagnostic TestsAntimalarialsArtesunateDrug Combinationsfanasil, pyrimethamine drug combinationNaphthyridinesPyrimethaminepyronaridineSulfadoxineDemocratic Republic of the CongoMalaria in pregnancyPyronaridine-artesunateSulfadoxine-PyrimethamineUltra-sensitive rapid diagnostic test

Identifiers

PMID39985024
PMCPMC11846385

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.