Evidence map›Paper›PMID 29764419›Full record

Trial reportMalaria journal2018

Pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial.

Johanna M Roth, Patrick Sawa, Nicodemus Makio, George Omweri, Victor Osoti, Selpha Okach, Felix Choy, Henk D F H Schallig, Pètra Mens

Registry-linked trialOpen access · goldAbstract readEquivalence TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Malaria journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02411994 (Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
3.7field-weighted citation impact, top 7% 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.

NCT02411994 phase3completednot on this map

Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya

TypeinterventionalSponsorRoyal Tropical InstituteRan2015 to 2017Enrolled197ConditionsMalariaArmsPyronaridine-artesunate, Artemether-lumefantrine combination
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
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  6. Efficacy, Safety and Tolerability of Pyronaridine-artesunate in Asymptomatic Malaria-infected Individuals: a Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
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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

9 authors at 2 institutions in 2 countries.

Johanna M RothDepartment of Medical Microbiology, Laboratory for Clinical Parasitology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. j.m.roth@amc.uva.nl.ORCID http://orcid.org/0000-0002-8750-1304
Patrick SawaHuman Health Division, International Centre of Insect Physiology and Ecology, Mbita Point, Kenya.
Nicodemus MakioHuman Health Division, International Centre of Insect Physiology and Ecology, Mbita Point, Kenya.
George OmweriHuman Health Division, International Centre of Insect Physiology and Ecology, Mbita Point, Kenya.
Victor OsotiHuman Health Division, International Centre of Insect Physiology and Ecology, Mbita Point, Kenya.
Selpha OkachHuman Health Division, International Centre of Insect Physiology and Ecology, Mbita Point, Kenya.
Felix ChoyDepartment of Medical Microbiology, Laboratory for Clinical Parasitology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Henk D F H SchalligDepartment of Medical Microbiology, Laboratory for Clinical Parasitology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Pètra MensDepartment of Medical Microbiology, Laboratory for Clinical Parasitology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
International Centre of Insect Physiology and Ecology · KEAmsterdam UMC Location University of Amsterdam · NL

Funding

EU FP7-Health-2013.0-1 601714
6 · The paper itself

Abstract

backgroundPyronaridine-artesunate is a novel artemisinin-based combination therapy. The efficacy and safety of pyronaridine-artesunate were compared with artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children.

methodsThis phase III open-label randomized controlled non-inferiority trial was conducted in Western Kenya. Children aged 6 months to ≤ 12 years with a bodyweight > 5 kg and microscopically confirmed P. falciparum malaria were randomly assigned in a 1:1 ratio to orally receive pyronaridine-artesunate or artemether-lumefantrine, dosed according to bodyweight, for 3 days.

resultsOf 197 participants, 101 received pyronaridine-artesunate and 96 received artemether-lumefantrine. The day-28 adequate clinical and parasitological response in the per-protocol population, PCR-corrected for reinfections, was 98.9% (93/94, 95% CI 94.2-99.8) for pyronaridine-artesunate and 96.4% (81/84, 95% CI 90.0-98.8) for artemether-lumefantrine. Pyronaridine-artesunate was found to be non-inferior to artemether-lumefantrine: the treatment difference was 2.5% (95% CI - 2.8 to 9.0). Adverse events occurred in 41.6% (42/101) and 34.4% (33/96) of patients in the pyronaridine-artesunate group and the artemether-lumefantrine group, respectively. No participants were found to have alanine or aspartate aminotransferase levels > 3 times the upper limit of normal.

conclusionsPyronaridine-artesunate was well tolerated, efficacious and non-inferior to artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria in Kenyan children. Results are in line with previous reports and inclusion of pyronaridine-artesunate in paediatric malaria treatment programmes should be considered. This study is registered at clinicaltrials.gov under NCT02411994. Registration date: 8 April 2015. https://clinicaltrials.gov/ct2/show/NCT02411994?term=pyronaridine-artesunate&cond=Malaria&cntry=KE&rank=1.

Indexed as

AntimalarialsArtemether, Lumefantrine Drug CombinationArtesunateChildChild, PreschoolFemaleHumansInfantKenyaMalaria, FalciparumMaleNaphthyridinesAntimalarialsArtemether, Lumefantrine Drug CombinationArtesunateNaphthyridinespyronaridineArtemether–lumefantrineKenyaMalariaPaediatricPlasmodium falciparumPyronaridine–artesunate

Identifiers

PMID29764419
PMCPMC5952621
OpenAlexW2805309778

What OpenQuestion holds

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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.