Evidence map›Paper›PMID 19099594›Full record

Trial reportMalaria journal2008

A randomized trial on effectiveness of artemether-lumefantrine versus artesunate plus amodiaquine for unsupervised treatment of uncomplicated Plasmodium falciparum malaria in Ghanaian children.

Robin Kobbe, Philipp Klein, Samuel Adjei, Solomon Amemasor, William Nana Thompson, Hanna Heidemann, Maja V Nielsen, Julia Vohwinkel, Benedikt Hogan, Benno Kreuels and 4 more

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

Trial report in Malaria journal, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 4 pooled it
6.0field-weighted citation impact, top 4% 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

15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  4. Artemisinin-based combination therapy for treating uncomplicated malaria.The Cochrane database of systematic reviews · 2009
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  9. Treatment with coartem (artemether-lumefantrine) in Papua New Guinea.The American journal of tropical medicine and hygiene · 2010
    Trial
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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

14 authors at 5 institutions in 2 countries.

Robin KobbeInfectious Disease Epidemiology, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany. kobbe@bni-hamburg.de
Philipp Klein
Samuel Adjei
Solomon Amemasor
William Nana Thompson
Hanna Heidemann
Maja V Nielsen
Julia Vohwinkel
Benedikt Hogan
Benno Kreuels
Martina Bührlen
Wibke Loag
Daniel Ansong
Jürgen May
Bernhard Nocht Institute for Tropical Medicine · DEPresbyterian University, Ghana · GHGhana Health Service · GHKwame Nkrumah University of Science and Technology · GHUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNumerous trials have demonstrated high efficacy and safety of artemisinin-based combination therapy (ACT) under supervised treatment. In contrast, effectiveness studies comparing different types of ACT applied unsupervised are scarce. The aim of this study was to compare effectiveness, tolerability and acceptance of artesunate plus amodiaquine (ASAQ) against that of artemether-lumefantrine (AL) in Ghanaian children with uncomplicated Plasmodium falciparum malaria.

methodsA randomized open-label trial was conducted at two district hospitals in the Ashanti region, Ghana, an area of intense malaria transmission. A total of 246 children under five years of age were randomly assigned to either ASAQ (Arsucam) or AL (Coartem). Study participants received their first weight-adjusted dose under supervision. After the parent/guardian was advised of times and mode of administration the respective three-day treatment course was completed unobserved at home. Follow-up visits were performed on days 3, 7, 14 and 28 to evaluate clinical and parasitological outcomes, adverse events, and haematological recovery. Length polymorphisms of variable regions of msp1 and msp2 were determined to differentiate recrudescences from reinfections. Acceptance levels of both treatment regimens were assessed by means of standardized interviews.

resultsAdequate clinical and parasitological responses after AL and ASAQ treatment were similar (88.3% and 91.7%, respectively). Interestingly, more late clinical failures until day 28 occurred in AL-treated children than in those who received ASAQ (17.5% and 7.3%, respectively; Hazard Ratio 2.41, 95% CI 1.00-5.79, p < 0.05).Haematological recovery and drug tolerability were not found to be significantly different in both study arms. The acceptance of treatment with ASAQ was higher than that with AL (rank-scores 10.6 and 10.3, respectively; p < 0.05).

conclusionUnobserved AL and ASAQ treatment showed high adequate clinical and parasitological responses, though AL was inferior in preventing late clinical failures.

Indexed as

AmodiaquineAnimalsArtemether, Lumefantrine Drug CombinationArtemisininsChild, PreschoolDrug CombinationsEthanolaminesFluorenesGhanaHumansInfantMalaria, FalciparumPatient Acceptance of Health CarePlasmodium falciparumTreatment OutcomeAmodiaquineamodiaquine, artesunate drug combinationArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFluorenes

Identifiers

PMID19099594
PMCPMC2625364
OpenAlexW2106806905

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.