Evidence map›Paper›PMID 41415126›Full record

ArticleBulletin of the World Health Organization2026

Single-step versus conventional injectable artesunate for severe malaria in children: an open label, non-inferiority randomized clinical trial, Democratic Republic of the Congo and United Republic of Tanzania.

Samwel Gesase, Marie Onyamboko, Caterina Fanello, Omari Abdul, Daddy Kalala Kayembe, Sarah Benie Bakomba, Daniel Tr Minja, Bejos Kifakiou Nzambiwishe, Pascal Epe Ekombolo, Anangisye Malabeja and 13 more

Abstract readEquivalence TrialMulticenter Study
In one paragraph

Article in Bulletin of the World Health Organization, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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.

Samwel GesaseNational Institute for Medical Research, Korogwe Research Laboratory, Tanga, United Republic of Tanzania.
Marie OnyambokoKinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
Caterina FanelloMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.
Omari AbdulNational Institute for Medical Research, Korogwe Research Laboratory, Tanga, United Republic of Tanzania.
Daddy Kalala KayembeKinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
Sarah Benie BakombaKinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
Daniel Tr MinjaNational Institute for Medical Research, Korogwe Research Laboratory, Tanga, United Republic of Tanzania.
Bejos Kifakiou NzambiwisheKinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
Pascal Epe EkomboloKinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.
Anangisye MalabejaNational Institute for Medical Research, Korogwe Research Laboratory, Tanga, United Republic of Tanzania.
Joyce R MbwanaNational Institute for Medical Research, Korogwe Research Laboratory, Tanga, United Republic of Tanzania.
Jaqueline DeenInstitute of Child Health and Human Development, University of the Philippines, Manila, Philippines.
George MtoveNational Institute for Medical Research, Korogwe Research Laboratory, Tanga, United Republic of Tanzania.
Bipin AdhikariMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.
Mohamed MapondelaNational Institute for Medical Research, Korogwe Research Laboratory, Tanga, United Republic of Tanzania.
Chiraporn TayaMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.
Brian MutindaMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.
Naomi WaithiraMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.
John Pa LusinguNational Institute for Medical Research, Korogwe Research Laboratory, Tanga, United Republic of Tanzania.
Lorenz von SeidleinMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.
Mavuto MukakaMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.
Arjen M DondorpMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.
Thomas J PetoMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok10400, Thailand.

Funding

Wellcome Trust
6 · The paper itself

Abstract

Objective: To determine time and cost differences between one- and two-step injectable artesunate formulations for treatment of severe malaria and compare their safety and treatment outcomes. Methods: We conducted an open-label randomized clinical trial at hospitals in Kinshasa, Democratic Republic of the Congo and Korogwe, United Republic of Tanzania in patients aged 3 months to 16 years with severe malaria. We randomly allocated patients to a new one-step injectable artesunate formulation or the conventional two-step formulation. After discharge, patients were followed for 4 weeks. The main outcomes evaluated were time and cost of administering treatment, and clinical and pharmacodynamic effects. Findings: Between 7 June 2022 and 11 August 2023, 200 patients were randomized (1:1) to either the one-step or two-step arm. Mean time to administer artesunate was 2 min 22 s (standard deviation, SD: 50 s) in the one-step arm and 3 min 41 s (SD: 95 s) in the two-step ( Conclusion: In children with severe malaria, one-step injectable artesunate was quicker and cheaper to administer and had equivalent safety and efficacy compared with the conventional formulation.

Indexed as

AntimalarialsArtesunateMalariaAdolescentChildChild, PreschoolDemocratic Republic of the CongoFemaleHumansInfantInjectionsMaleTanzaniaTreatment OutcomeAntimalarialsArtesunate

Identifiers

PMID41415126
PMCPMC12709452

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.