Evidence map›Paper›PMID 37646608›Full record

Trial reportParasite (Paris, France)2023

Therapeutic efficacy and safety of artesunate + amodiaquine and artemether + lumefantrine in treating uncomplicated Plasmodium falciparum malaria in children on the rainy south-east coast of Madagascar.

Judickaëlle Irinantenaina, Gwénaëlle Carn, Dina Ny Aina Liantsoa Randriamiarinjatovo, Aina Nirina Harimanana, Seheno Razanatsiorimalala, Nicolas Ralemary, Maurice Randriarison, Celestin Razafinjato, Raphael Hotahiene, Milijaona Randrianarivelojosia

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Parasite (Paris, France), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Review
  2. 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

10 authors.

Judickaëlle IrinantenainaUnité d'Epidémiologie et de Recherche Clinique, Institut Pasteur de Madagascar, Antananarivo, 101, Madagascar.ORCID 0000-0002-8686-8411
Gwénaëlle CarnUnité d'Epidémiologie et de Recherche Clinique, Institut Pasteur de Madagascar, Antananarivo, 101, Madagascar - Drugs for Neglected Diseases initiative (DNDi), 1202, Geneva, Switzerland.ORCID 0009-0001-0656-0557
Dina Ny Aina Liantsoa RandriamiarinjatovoUnité de Parasitologie, Institut Pasteur de Madagascar, Antananarivo, 101, Madagascar.ORCID 0000-0002-6196-8504
Aina Nirina HarimananaUnité d'Epidémiologie et de Recherche Clinique, Institut Pasteur de Madagascar, Antananarivo, 101, Madagascar.ORCID 0000-0001-6690-2945
Seheno RazanatsiorimalalaUnité de Parasitologie, Institut Pasteur de Madagascar, Antananarivo, 101, Madagascar.ORCID 0009-0006-9781-3295
Nicolas RalemaryDirection Régionale de la Santé Publique Atsimo Atsinana, Farafangana, 309, Madagascar.
Maurice RandriarisonService de Santé de District de Santé Publique, Mananjary, 317, Madagascar.
Celestin RazafinjatoNational Malaria Control Program, Ministry of Health, Antananarivo, 101, Madagascar.
Raphael HotahieneDirection de Lutte contre les Maladies Transmissibles, Ministère de la santé publique, Antananarivo, 101, Madagascar.ORCID 0009-0005-2865-6436
Milijaona RandrianarivelojosiaUnité de Parasitologie, Institut Pasteur de Madagascar, Antananarivo, 101, Madagascar - Faculté des Sciences, Université de Toliara, Toliara, 601, Madagascar.ORCID 0000-0003-2767-0349

Funding

US Agency for International Development Grant No. AID-687-G-13-00003
6 · The paper itself

Abstract

Malaria is a major public health problem in Madagascar, particularly in coastal areas. We conducted a randomized, controlled, parallel-group study of artemisinin-based combination therapy (ACT) in Mananjary and Farafangana, two localities on the rainy south-east coast of Madagascar, from March to September 2018. The efficacy and safety of artesunate + amodiaquine (ASAQ) and artemether + lumefantrine (AL) were assessed according to the WHO protocol with a 28-day follow-up. Children aged 6 months to 14 years with uncomplicated Plasmodium falciparum malaria were randomized to receive ASAQ or AL for three days (1:1). 347/352 (98.5%) randomized patients reached the study endpoint on day 28. Crude adequate clinical and parasitological response (ACPR) rates were 100% (95% CI: 98.8-100%) in the ASAQ group and 96% (95% CI: 93.1-98.9%) in the AL group (per protocol population). However, the PCR-corrected ACPR rate was 97.7% (95% CI: 95.4-100%) in the AL group. Two cases of recrudescence and three of re-infection were observed. Mild and moderate adverse events, including gastrointestinal and/or nervous disorders, were reported in 11.9% (42/352) of patients. We found that ASAQ and AL were safe and efficacious for treating uncomplicated P. falciparum malaria. They may be used for treatment at health facilities and at the community level, and for mass drug administration campaigns.

Indexed as

AmodiaquineMalaria, FalciparumArtemether, Lumefantrine Drug CombinationArtesunateChildHumansMadagascarAmodiaquineArtemether, Lumefantrine Drug CombinationArtesunateArtemether-lumefantrineArtesunate-amodiaquineEfficacyMadagascar

Identifiers

PMID37646608
PMCPMC10467351

What OpenQuestion holds

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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.