Evidence map›Paper›PMID 27776521›Full record

ArticleBMC medicine2016

Efficacy of artemether-lumefantrine in relation to drug exposure in children with and without severe acute malnutrition: an open comparative intervention study in Mali and Niger.

Lise Denoeud-Ndam, Alassane Dicko, Elisabeth Baudin, Ousmane Guindo, Francesco Grandesso, Halimatou Diawara, Sibiri Sissoko, Koualy Sanogo, Seydou Traoré, Sekouba Keita and 11 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01958905 (Efficacy and Bio-availability of Artemether-Lumefantrine Fixed Combination in Severely Malnourished Children Compared to Non-severely Malnourished Children), which is not on this map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT01958905 nacompletednot on this map

Efficacy and Bio-availability of Artemether-Lumefantrine Fixed Combination in Severely Malnourished Children Compared to Non-severely Malnourished Children

TypeinterventionalSponsorEpicentreRan2013 to 2015Enrolled399ConditionsMalaria, Severe Acute MalnutritionArmsArtemether-lumefantrine fixed combination
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 28 citations in OpenAlex.

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  17. Malaria and Nutritional Status Among Children With Severe Acute Malnutrition in Niger: A Prospective Cohort Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 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

21 authors at 8 institutions in 7 countries.

Lise Denoeud-NdamEpicentre, Paris, France. lise.denoeud@epicentre.msf.org.
Alassane DickoMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Elisabeth BaudinEpicentre, Paris, France.
Ousmane GuindoEpicentre, Maradi, Niger.
Francesco GrandessoEpicentre, Paris, France.
Halimatou DiawaraMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Sibiri SissokoMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Koualy SanogoMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Seydou TraoréMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Sekouba KeitaMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Amadou BarryMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Martin de SmetMedecins Sans Frontieres, Brussels, Belgium.
Estrella LasryMedecins Sans Frontieres, New York, NY, USA.
Michiel SmitDivision of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Lubbe WiesnerDivision of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Karen I BarnesDivision of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Abdoulaye A DjimdeMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Philippe J GuerinWorldWide Antimalarial Resistance Network (WWARN), Oxford, UK.
Rebecca F GraisEpicentre, Paris, France.
Ogobara K DoumboMalaria Research and Training Center, Faculté de Médecine et d'Odonto-stomatologie et Faculté de Pharmacie, Université des Sciences Techniques et Technologies de Bamako, Bamako, Mali.
Jean-François EtardEpicentre, Paris, France.
Université des Sciences, des Techniques et des Technologies de Bamako · MLUniversity of Cape Town · ZAInserm · FRMédecins Sans Frontières · USMédecins Sans Frontières · BEUnited Nations Children's Fund Niger · NEUniversity of Oxford · GBWorldwide Veterinary Service · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSevere acute malnutrition (SAM) affects almost all organs and has been associated with reduced intestinal absorption of medicines. However, very limited information is available on the pharmacokinetic properties of antimalarial drugs in this vulnerable population. We assessed artemether-lumefantrine (AL) clinical efficacy in children with SAM compared to those without.

methodsChildren under 5 years of age with uncomplicated P. falciparum malaria were enrolled between November 2013 and January 2015 in Mali and Niger, one third with uncomplicated SAM and two thirds without. AL was administered under direct observation with a fat intake consisting of ready-to-use therapeutic food (RUTF - Plumpy'Nut®) in SAM children, twice daily during 3 days. Children were followed for 42 days, with PCR-corrected adequate clinical and parasitological response (ACPR) at day 28 as the primary outcome. Lumefantrine concentrations were assessed in a subset of participants at different time points, including systematic measurements on day 7.

resultsA total of 399 children (360 in Mali and 39 in Niger) were enrolled. Children with SAM were younger than their non-SAM counterparts (mean 17 vs. 28 months, P < 0.0001). PCR-corrected ACPR was 100 % (95 % CI, 96.8-100 %) in SAM at both day 28 and 42, versus 98.8 % (96.4-99.7 %) at day 28 and 98.3 % (95.6-99.4 %) at day 42 in non-SAM (P = 0.236 and 0.168, respectively). Compared to younger children, children older than 21 months experienced more reinfections and SAM was associated with a greater risk of reinfection until day 28 (adjusted hazard ratio = 2.10 (1.04-4.22), P = 0.038). Day 7 lumefantrine concentrations were significantly lower in SAM than non-SAM (median 251 vs. 365 ng/mL, P = 0.049).

conclusionsThis study shows comparable therapeutic efficacy of AL in children without SAM and in those with SAM when given in combination with RUTF, but a higher risk of reinfection in older children suffering from SAM. This could be associated with poorer exposure to the antimalarials as documented by a lower lumefantrine concentration on day 7.

trial registrationClinicalTrials.gov: NCT01958905 , registration date: October 7, 2013.

Indexed as

AntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsChild, PreschoolDrug CombinationsEthanolaminesFemaleFluorenesHumansInfantMalaria, FalciparumMaleMaliNigerSevere Acute MalnutritionAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFluorenesArtemether-lumefantrineMaliNigerPharmacokineticsPlasmodium falciparum malariaSevere acute malnutritionTreatment outcome

Identifiers

PMID27776521
PMCPMC5079061
OpenAlexW2534710988

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.