Evidence map›Paper›PMID 23866774›Full record

Trial reportMalaria journal2013

Efficacy of artesunate-amodiaquine and artemether-lumefantrine fixed-dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria among children aged six to 59 months in Nimba County, Liberia: an open-label randomized non-inferiority trial.

Birgit Schramm, Parastou Valeh, Elisabeth Baudin, Charles S Mazinda, Richard Smith, Loretxu Pinoges, Mehul Dhorda, Yap Boum, Timothy Sundaygar, Yah M Zolia and 8 more

Open access · goldAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Malaria journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 6 pooled it
4.9field-weighted citation impact, top 5% 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

24 citing papers in PubMed, 6 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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  17. Polymorphisms in the K13 Gene inThe American journal of tropical medicine and hygiene · 2018
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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

18 authors at 8 institutions in 6 countries.

Birgit SchrammEpicentre, 75011 Paris, France. birgit.schramm@epicentre.msf.org
Parastou Valeh
Elisabeth Baudin
Charles S Mazinda
Richard Smith
Loretxu Pinoges
Mehul Dhorda
Yap Boum
Timothy Sundaygar
Yah M Zolia
Joel J Jones
Eric Comte
Pascal Houzé
Vincent Jullien
Gwenaelle Carn
Jean-René Kiechel
Elizabeth A Ashley
Philippe J Guérin
Drugs for Neglected Diseases Initiative · CHEpicentre Uganda · UGMinistry of Health and Social Welfare · LRUniversity of Oxford · GBDélégation Paris 5 · FREpicentre (South Africa) · ZAHôpital Saint-Louis · FRMédecins Sans Frontières · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProspective efficacy monitoring of anti-malarial treatments is imperative for timely detection of resistance development. The in vivo efficacy of artesunate-amodiaquine (ASAQ) fixed-dose combination (FDC) was compared to that of artemether-lumefantrine (AL) among children aged six to 59 months in Nimba County, Liberia, where Plasmodium falciparum malaria is endemic and efficacy data are scarce.

methodsAn open-label, randomized controlled non-inferiority trial compared the genotyping adjusted day 42 cure rates of ASAQ FDC (ASAQ Winthrop®) to AL (Coartem®) in 300 children aged six to 59 months with uncomplicated falciparum malaria. Inclusion was between December 2008 and May 2009. Randomization (1:1) was to a three-day observed oral regimen (ASAQ: once a day; AL: twice a day, given with fatty food). Day 7 desethylamodiaquine and lumefantrine blood-concentrations were also measured.

resultsThe day 42 genotyping-adjusted cure rate estimates were 97.3% [95% CI: 91.6-99.1] for ASAQ and 94.2% [88.1-97.2] for AL (Kaplan-Meier survival estimates). The difference in day 42 cure rates was -3.1% [upper limit 95% CI: 1.2%]. These results were confirmed by observed proportion of patients cured at day 42 on the per-protocol population. Parasite clearance was 100% (ASAQ) and 99.3% (AL) on day 3. The probability to remain free of re-infection was 0.55 [95% CI: 0.46-0.63] (ASAQ) and 0.66 [0.57-0.73] (AL) (p = 0.017).

conclusionsBoth ASAQ and AL were highly efficacious and ASAQ was non-inferior to AL. The proportion of patients with re-infection was high in both arms in this highly endemic setting. In 2010, ASAQ FDC was adopted as the first-line national treatment in Liberia. Continuous efficacy monitoring is recommended.

trial registrationThe protocols were registered with Current Controlled Trials, under the identifier numbers ISRCTN51688713, ISRCTN40020296.

Indexed as

AmodiaquineAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsChild, PreschoolDrug CombinationsEthanolaminesFemaleFluorenesHumansInfantLiberiaMalaria, FalciparumMaleTreatment OutcomeAmodiaquineamodiaquine, artesunate drug combinationAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFluorenes

Identifiers

PMID23866774
PMCPMC3728070
OpenAlexW2143754068

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.