Evidence map›Paper›PMID 23234606›Full record

Trial reportMalaria journal2012

Efficacy and tolerability of a new formulation of artesunate-mefloquine for the treatment of uncomplicated malaria in adult in Senegal: open randomized trial.

Roger C K Tine, Babacar Faye, Khadime Sylla, Jean L Ndiaye, Magatte Ndiaye, Doudou Sow, Aminata C Lo, Annie Abiola, Mamadou C Ba, Oumar Gaye

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Malaria journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.6field-weighted citation impact, top 15% 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

9 citing papers in PubMed, 20 citations in OpenAlex.

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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 at 1 institution in 1 country.

Roger C K TineDepartment of Parasitology, Faculty of Medicine, University Cheikh Anta DIOP, Dakar, Senegal. roger.tine@ucad.edu.sn
Babacar Faye
Khadime Sylla
Jean L Ndiaye
Magatte Ndiaye
Doudou Sow
Aminata C Lo
Annie Abiola
Mamadou C Ba
Oumar Gaye
Cheikh Anta Diop University · SN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrompt treatment of malaria attacks with arteminisin-based combination therapy (ACT) is an essential tool for malaria control. A new co-blister tablet of artesunate-mefloquine (AM) with 25 mg/kg mefloquine has been developed for the management of uncomplicated malaria attacks. This non-inferiority randomized trial, was conducted to evaluate the efficacy and safety of the new formulation of AM in comparison to artemether-lumefantrine (AL) for the treatment of acute uncomplicated Plasmodium falciparum malaria in adults in Senegal.

methodsThe study was carried out from September to December 2010 in two health centres in Senegal. The study end points included (i) PCR corrected adequate clinical and parasitological response (ACPR) at day 28, (ii) ACPR at days 42 and 63, (iii) parasites and fever clearance time, (iv) incidence of adverse events and patients biological profile at day 7 using the WHO 2003 protocol for anti-malarial drug evaluation.

resultsOverall, 310 patients were randomized to receive either AM (n = 157) or AL (n = 153). PCR corrected ACPR at day 28 was at 95.5% in the AM arm while that in the AL arm was at 96.7% (p = 0.83). Therapeutic efficacy was at 98.5% in the AM arm versus 98.2% in the AL group at day 42 (p = 1). At day 63, ACPR in the AM and AL arms was at 98.2% and 97.7%, respectively (p = 0.32). The two treatments were well tolerated with similar biological profile at day 7. However, dizziness was more frequent in the AM arm.

conclusionArtesunate-mefloquine (25 mg/Kg mefloquine) is efficacious and well-tolerated for the treatment of uncomplicated P. falciparum malaria in adult patients.

Indexed as

AdolescentAdultAntigens, ProtozoanAntimalarialsArtemisininsArtesunateBase SequenceChemistry, PharmaceuticalDNA, ProtozoanDrug CombinationsFemaleGenes, ProtozoanHumansMalaria, FalciparumMaleMefloquineAntigens, ProtozoanAntimalarialsArtemisininsArtesunateDNA, ProtozoanDrug CombinationsMefloquineMerozoite Surface Protein 1merozoite surface protein 2, PlasmodiumProtozoan Proteins

Identifiers

PMID23234606
PMCPMC3554515
OpenAlexW2110023396

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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.