Evidence map›Paper›PMID 32580771›Full record

Trial reportMalaria journal2020

Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine and prevalence of molecular markers associated with resistance, Guinea: an open-label two-arm randomised controlled trial.

Abdoul Habib Beavogui, Alioune Camara, Alexandre Delamou, Mamadou Saliou Diallo, Abdoulaye Doumbouya, Karifa Kourouma, Patrice Bouedouno, Timothée Guilavogui, Samaly Dos Santos Souza, Julia Kelley and 3 more

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

Trial report in Malaria journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
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

13 authors at 4 institutions in 3 countries.

Abdoul Habib BeavoguiCentre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea. bea@maferinyah.org.ORCID http://orcid.org/0000-0003-4950-6224
Alioune CamaraCentre d'Excellence Africain pour la Prévention et le Contrôle des Maladies Transmissibles (CEA-PCMT), Gamal Abdel Nasser University, Conakry, Guinea.
Alexandre DelamouCentre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.
Mamadou Saliou DialloCentre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.
Abdoulaye DoumbouyaCentre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.
Karifa KouroumaCentre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.
Patrice BouedounoCentre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea.
Timothée GuilavoguiDirection of Epidemiology, Ministry of Health, Conakry, Guinea.
Samaly Dos Santos SouzaMalaria Branch, Centers for Disease Control and Prevention, Atlanta, USA.
Julia KelleyAtlanta Research and Education Foundation and Malaria Branch, Centers for Disease Control and Prevention, Atlanta, USA.
Eldin TalundzicMalaria Branch, Centers for Disease Control and Prevention, Atlanta, USA.
Aissata FofanaRTI International, Conakry, Guinea.
Mateusz M PlucinskiMalaria Branch and U.S. President's Malaria Initiative, Centers for Disease Control and Prevention, Atlanta, USA.
Centers for Disease Control and Prevention · USInstitut de Recherche Agronomique de Guinée · GNGamal Abdel Nasser University of Conakry · GNMinistry of Health and Public Hygiene · GN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnti-malarial resistance is a threat to recent gains in malaria control. This study aimed to assess the efficacy and safety of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) in the management of uncomplicated malaria and to measure the prevalence of molecular markers of resistance of Plasmodium falciparum in sentinel sites in Maferinyah and Labé Health Districts in Guinea in 2016.

methodsThis was a two-arm randomised controlled trial of the efficacy of AL and ASAQ among children aged 6-59 months with uncomplicated Plasmodium falciparum malaria in two sites. Children were followed for 28 days to assess clinical and parasitological response. The primary outcome was the Kaplan-Meier estimate of Day 28 (D28) efficacy after correction by microsatellite-genotyping. Pre-treatment (D0) and day of failure samples were assayed for molecular markers of resistance in the pfk13 and pfmdr1 genes.

resultsA total of 421 participants were included with 211 participants in the Maferinyah site and 210 in Labé. No early treatment failure was observed in any study arms. However, 22 (5.3%) participants developed a late treatment failure (8 in the ASAQ arm and 14 in the AL arm), which were further classified as 2 recrudescences and 20 reinfections. The Kaplan-Meier estimate of the corrected efficacy at D28 was 100% for both AL and ASAQ in Maferinyah site and 99% (95% Confidence Interval: 97.2-100%) for ASAQ and 99% (97.1-100%) for AL in Labé. The majority of successfully analysed D0 (98%, 380/389) and all day of failure (100%, 22/22) samples were wild type for pfk13. All 9 observed pfk13 mutations were polymorphisms not associated with artemisinin resistance. The NFD haplotype was the predominant haplotype in both D0 (197/362, 54%) and day of failure samples (11/18, 61%) successfully analysed for pfmdr1.

conclusionThis study observed high efficacy and safety of both ASAQ and AL in Guinea, providing evidence for their continued use to treat uncomplicated malaria. Continued monitoring of ACT efficacy and safety and molecular makers of resistance in Guinea is important to detect emergence of parasite resistance and to inform evidence-based malaria treatment policies.

Indexed as

Drug ResistanceAmodiaquineAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsChild, PreschoolDrug CombinationsFemaleGuineaHumansInfantMalaria, FalciparumMalePlasmodium falciparumTreatment FailureAmodiaquineamodiaquine, artesunate drug combinationAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsArtemether–lumefantrineArtesunate–amodiaquineEfficacyGuineaMolecular makersPlasmodium falciparum

Identifiers

PMID32580771
PMCPMC7315541
OpenAlexW3037963376

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.