Evidence map›Paper›PMID 28049523›Full record

ArticleMalaria journal2017

Safety of a fixed-dose combination of artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in real-life conditions of use in Côte d'Ivoire.

Serge-Brice Assi, Yapo Thomas Aba, Jean Claude Yavo, Abouo Franklin Nguessan, N'cho Bertin Tchiekoi, Koffi Moïse San, Emmanuel Bissagnéné, Stephan Duparc, Valérie Lameyre, Mea Antoine Tanoh

Open access · goldAbstract read
In one paragraph

Article in Malaria journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
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  5. Article
  6. Review
  7. Review
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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 7 institutions in 3 countries.

Serge-Brice AssiInstitut Pierre Richet (IPR)/Institut National de Santé Publique (INSP), Bouaké, Ivory Coast. assisergi@yahoo.fr.ORCID 0000-0001-7055-5405
Yapo Thomas AbaInfectious and Tropical Diseases Department, Bouaké University Hospital, Bouaké, Ivory Coast.
Jean Claude YavoPharmacovigilance Unit, Medical Sciences, Felix Houphouët-Boigny, Abidjan, Ivory Coast.
Abouo Franklin NguessanInfectious and Tropical Diseases Unit, Treichville University Hospital, Abidjan, Ivory Coast.
N'cho Bertin TchiekoiInstitut Pierre Richet (IPR)/Institut National de Santé Publique (INSP), Bouaké, Ivory Coast.
Koffi Moïse SanNational Malaria Control Programme, Abidjan, Ivory Coast.
Emmanuel BissagnénéInfectious and Tropical Diseases Unit, Treichville University Hospital, Abidjan, Ivory Coast.
Stephan DuparcMedicines for Malaria Venture, Geneva, Switzerland.
Valérie LameyreSanofi Access to Medicines, Gentilly, France.
Mea Antoine TanohNational Malaria Control Programme, Abidjan, Ivory Coast.
Institut Universitaire d'Abidjan · CIUniversity Hospital Medical Center at Treichville · CIInstitut National de Santé Publique · CIMedicines for Malaria Venture · CHSanofi (France) · FRUniversité Alassane Ouattara · CIUniversité Félix Houphouët-Boigny · CI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn many malaria-endemic, sub-Saharan African countries, existing pharmacovigilance systems are not sufficiently operational to document reliably the safety profile of anti-malarial drugs. This study describes the implantation of a community-based pharmacovigilance system in Côte d'Ivoire and its use to document the safety of ASAQ Winthrop

methodsThis prospective, longitudinal, descriptive, non-comparative, non-interventional study on the use of artesunate-amodiaquine in real-life conditions of use was conducted in seven Community Health Centres of the Agboville district in Côte d'Ivoire. Twenty trained Health Centre employees and 70 trained community health workers were involved in data collection in the field. All patients with suspected uncomplicated falciparum malaria, seeking treatment at one of the participating Health Centres, and treated with artesunate-amodiaquine could be enrolled. Two visits were planned, one for inclusion at the Health Centre and a second at home, performed by a community health worker 3-10 days after the inclusion visit. Administration of artesunate-amodiaquine was unsupervised. Adverse events (AEs) were documented at the home visit or during any unexpected visit to the Health Centre or to the hospital and coded and adjudicated by a local pharmacovigilance committee. Symptoms suggestive of hepatic failure, severe neutropaenia, extrapyramidal disorders and retinopathy were considered a priori as AEs of special interest.

resultsSome 15,228 malaria episodes in 12,198 patients were evaluated; 2545 AEs were documented during 1978 malaria episodes (13.0%). The most frequently observed events were asthenia (682 cases), vomiting (482 cases) and somnolence (174 cases). Most reported AEs were of mild or moderate intensity and resolved without corrective treatment. One-hundred and five (105) AEs reported during 100 episodes (0.7%) were considered as serious. Three serious cases of transient extrapyramidal disorders, identified as AEs of special interest were reported in three patients.

conclusionThe fixed dose artesunate-amodiaquine combination ASAQ Winthrop

Indexed as

PharmacovigilanceAdolescentAdultAgedAged, 80 and overAmodiaquineAntimalarialsArtemisininsChildChild, PreschoolCote d'IvoireDrug CombinationsDrug-Related Side Effects and Adverse ReactionsFemaleHumansInfantAmodiaquineamodiaquine, artesunate drug combinationAntimalarialsArtemisininsDrug CombinationsArtesunate–amodiaquineCôte d’IvoireMalariaPharmacovigilance

Identifiers

PMID28049523
PMCPMC5209945
OpenAlexW2567561387

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.