Evidence map›Paper›PMID 34600544›Full record

ArticleMalaria journal2021

In vivo efficacy and safety of artemether-lumefantrine and amodiaquine-artesunate for uncomplicated Plasmodium falciparum malaria in Mozambique, 2018.

Abel Nhama, Lídia Nhamússua, Eusébio Macete, Quique Bassat, Crizolgo Salvador, Sónia Enosse, Baltazar Candrinho, Eva Carvalho, Arsénio Nhacolo, Arlindo Chidimatembue and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Malaria journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04370977 (In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Children), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT04370977 phase4completednot on this map

In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Children: A Multisite Open Label, Two-cohort Clinical Trial in Mozambique

TypeinterventionalSponsorCentro de Investigacao em Saude de ManhicaRan2018 to 2019Enrolled630ConditionsMalariaArmsCoartem™ (Artemether-lumefantrine combination), Winthrop™ (Amodiaquine-artesunate combination)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Mapping Antimalarial Drug Resistance in Mozambique: A Systematic Review ofInternational journal of molecular sciences · 2024
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Repurposing Histaminergic Drugs in Multiple Sclerosis.International journal of molecular sciences · 2022
    Article
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 5 institutions in 4 countries.

Abel NhamaCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Lídia NhamússuaCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Eusébio MaceteCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Quique BassatCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Crizolgo SalvadorInstituto Nacional de Saúde (INS), Ministério da Saúde, Maputo, Mozambique.
Sónia EnosseInstituto Nacional de Saúde (INS), Ministério da Saúde, Maputo, Mozambique.
Baltazar CandrinhoPrograma Nacional de Controlo da Malária, Ministério da Saúde, Maputo, Mozambique.
Eva CarvalhoWorld Health Organization, WHO Country Office Maputo, Maputo, Mozambique.
Arsénio NhacoloCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Arlindo ChidimatembueCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Abuchahama SaifodineUnited States President's Malaria Initiative, United States Agency for International Development, Maputo, Mozambique.
Rose ZulligerUnited States President's Malaria Initiative, Centers for Disease Control and Prevention, Maputo, Mozambique.
Naomi LucchiMalaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Samaly S SvigelMalaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Leah F MoriartyMalaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Eric S HalseyMalaria Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Alfredo MayorCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Pedro AideCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique. pedro.aide@manhica.net.ORCID http://orcid.org/0000-0002-2379-6529
Manhiça Health Research Centre · MZCenters for Disease Control and Prevention · USInstituto Nacional de Saúde · MZInstitució Catalana de Recerca i Estudis Avançats · ESUnited States Agency for International Development · US

Funding

U.S. Presient's Malaria Initiative RFA-656-16-00004World Health Organization 001
6 · The paper itself

Abstract

backgroundArtemisinin-based combination therapy (ACT) has been the recommended first-line treatment for uncomplicated malaria in Mozambique since 2006, with artemether-lumefantrine (AL) and amodiaquine-artesunate (AS-AQ) as the first choice. To assess efficacy of currently used ACT, an in vivo therapeutic efficacy study was conducted.

methodsThe study was conducted in four sentinel sites: Montepuez, Moatize, Mopeia and Massinga. Patients between 6 and 59 months old with uncomplicated Plasmodium falciparum malaria (2000-200,000 parasites/µl) were enrolled between February and September of 2018, assigned to either an AL or AS-AQ treatment arm, and monitored for 28 days. A Bayesian algorithm was applied to differentiate recrudescence from new infection using genotyping data of seven neutral microsatellites. Uncorrected and PCR-corrected efficacy results at day 28 were calculated.

resultsTotals of 368 and 273 patients were enrolled in the AL and AS-AQ arms, respectively. Of these, 9.5% (35/368) and 5.1% (14/273) were lost to follow-up in the AL and AS-AQ arms, respectively. There were 48 and 3 recurrent malaria infections (late clinical and late parasitological failures) in the AL and AS-AQ arms, respectively. The day 28 uncorrected efficacy was 85.6% (95% confidence interval (CI) 81.3-89.2%) for AL and 98.8% (95% CI 96.7-99.8%) for AS-AQ, whereas day 28 PCR-corrected efficacy was 97.9% (95% CI 95.6-99.2%) for AL and 99.6% (95% CI 97.9-100%) for AS-AQ. Molecular testing confirmed that 87.4% (42/48) and 33.3% (1/3) of participants with a recurrent malaria infection in the AL and AS-AQ arms were new infections; an expected finding in a high malaria transmission area. Adverse events were documented in less than 2% of participants for both drugs.

conclusionBoth AL and AS-AQ have therapeutic efficacies well above the 90% WHO recommended threshold and remain well-tolerated in Mozambique. Routine monitoring of therapeutic efficacy should continue to ensure the treatments remain efficacious. Trial registration Clinicaltrials.gov: NCT04370977.

Indexed as

AmodiaquineAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsChild, PreschoolDrug CombinationsHumansInfantMalaria, FalciparumMozambiqueParasitemiaSafetyTreatment OutcomeAmodiaquineamodiaquine, artesunate drug combinationAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsArtemether–lumefantrineArtesunate–amodiaquineChildrenEfficacyMozambiqueUncomplicated malaria

Identifiers

PMID34600544
PMCPMC8487544
OpenAlexW3168781683

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.