Evidence map›Paper›PMID 19936217›Full record

Trial reportPloS one2009

Dihydroartemisinin-piperaquine and artemether-lumefantrine for treating uncomplicated malaria in African children: a randomised, non-inferiority trial.

Quique Bassat, Modest Mulenga, Halidou Tinto, Patrice Piola, Steffen Borrmann, Clara Menéndez, Michael Nambozi, Innocent Valéa, Carolyn Nabasumba, Philip Sasi and 5 more

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

Trial report in PloS one, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 10 pooled it
13.1field-weighted citation impact, top 1% 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

93 citing papers in PubMed, 10 syntheses or guidelines pooled it, 161 citations in OpenAlex.

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33 more citing papers are in PubMed but not listed here.

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

15 authors at 10 institutions in 11 countries.

Quique BassatBarcelona Centre for International Health Research (CRESIB), Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.
Modest Mulenga
Halidou Tinto
Patrice Piola
Steffen Borrmann
Clara Menéndez
Michael Nambozi
Innocent Valéa
Carolyn Nabasumba
Philip Sasi
Antonella Bacchieri
Marco Corsi
David Ubben
Ambrose Talisuna
Umberto D'Alessandro
Centre Muraz · BFEpicentre Uganda · UGInstituut voor Tropische Geneeskunde · BESigma Tau (Italy) · ITTropical Diseases Research Centre · ZMKenya Medical Research Institute · KEManhiça Health Research Centre · MZMedicines for Malaria Venture · CHMuhimbili University of Health and Allied Sciences · TZUniversitat de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundArtemisinin combination therapies (ACTs) are currently the preferred option for treating uncomplicated malaria. Dihydroartemisinin-piperaquine (DHA-PQP) is a promising fixed-dose ACT with limited information on its safety and efficacy in African children. METHODOLOGY/PRINCIPAL

findingsThe non-inferiority of DHA-PQP versus artemether-lumefantrine (AL) in children 6-59 months old with uncomplicated P. falciparum malaria was tested in five African countries (Burkina Faso, Kenya, Mozambique, Uganda and Zambia). Patients were randomised (2:1) to receive either DHA-PQP or AL. Non-inferiority was assessed using a margin of -5% for the lower limit of the one-sided 97.5% confidence interval on the treatment difference (DHA-PQP vs. AL) of the day 28 polymerase chain reaction (PCR) corrected cure rate. Efficacy analysis was performed in several populations, and two of them are presented here: intention-to-treat (ITT) and enlarged per-protocol (ePP). 1553 children were randomised, 1039 receiving DHA-PQP and 514 AL. The PCR-corrected day 28 cure rate was 90.4% (ITT) and 94.7% (ePP) in the DHA-PQP group, and 90.0% (ITT) and 95.3% (ePP) in the AL group. The lower limits of the one-sided 97.5% CI of the difference between the two treatments were -2.80% and -2.96%, in the ITT and ePP populations, respectively. In the ITT population, the Kaplan-Meier estimate of the proportion of new infections up to Day 42 was 13.55% (95% CI: 11.35%-15.76%) for DHA-PQP vs 24.00% (95% CI: 20.11%-27.88%) for AL (p<0.0001). CONCLUSIONS/SIGNIFICANCE: DHA-PQP is as efficacious as AL in treating uncomplicated malaria in African children from different endemicity settings, and shows a comparable safety profile. The occurrence of new infections within the 42-day follow up was significantly lower in the DHA-PQP group, indicating a longer post-treatment prophylactic effect.

trial registrationControlled-trials.com ISRCTN16263443.

Indexed as

AfricaAntiparasitic AgentsArtemetherArtemisininsChild, PreschoolDrug Therapy, CombinationEthanolaminesFluorenesHumansInfantLumefantrineMalariaMalaria, FalciparumPiperazinesPlasmodium falciparumPolymerase Chain ReactionAntiparasitic AgentsArtemetherArtemisininsartenimolEthanolaminesFluorenesLumefantrinepiperaquinePiperazinesQuinolines

Identifiers

PMID19936217
PMCPMC2776302
OpenAlexW2128743785

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.