Evidence map›Paper›PMID 23113947›Full record

Trial reportMalaria journal2012

Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial.

Kassoum Kayentao, Ogobara K Doumbo, Louis K Pénali, André T Offianan, Kirana M Bhatt, Joshua Kimani, Antoinette K Tshefu, Jack H T Kokolomami, Michael Ramharter, Pablo Martinez de Salazar and 8 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Malaria journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 36 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT00541385 phase3completednot on this map

Phase III Comparative, Open-labelled, Randomised, Clinical Study to Assess a Fixed Dose of Oral Pyronaridine Artesunate Granule Formulation vs. Coartem® Crushed Tablets in Infants With Acute Uncomplicated Plasmodium Falciparum Malaria

TypeinterventionalSponsorMedicines for Malaria VentureRan2007 to 2008Enrolled535ConditionsMalariaArmspyronaridine artesunate, arthemeter lumefantrine
NCT05757167 phase4active not recruitingnot on this mapstarted 2023, after this paper: background citation

Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity

TypeinterventionalSponsorDuke UniversityRan2023 to 2026Enrolled2,174ConditionsMalaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, PregnancyArmsMalaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  10. 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

18 authors.

Kassoum KayentaoMalaria Research and Training Center, Faculté de Médecine de Pharmacie et d'Odonto-Stomatologie, Bamako, Mali.
Ogobara K Doumbo
Louis K Pénali
André T Offianan
Kirana M Bhatt
Joshua Kimani
Antoinette K Tshefu
Jack H T Kokolomami
Michael Ramharter
Pablo Martinez de Salazar
Alfred B Tiono
Alphonse Ouédraogo
Maria Dorina G Bustos
Frederick Quicho
Isabelle Borghini-Fuhrer
Stephan Duparc
Chang-Sik Shin
Lawrence Fleckenstein

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildren are most vulnerable to malaria. A pyronaridine-artesunate pediatric granule formulation is being developed for the treatment of uncomplicated Plasmodium falciparum malaria.

methodsThis phase III, multi-center, comparative, open-label, parallel-group, controlled clinical trial included patients aged ≤12 years, bodyweight ≥5 to <25 kg, with a reported history of fever at inclusion or in the previous 24 h and microscopically-confirmed uncomplicated P. falciparum malaria. Patients were randomized (2:1) to pyronaridine-artesunate granules (60/20 mg) once daily or artemether-lumefantrine crushed tablets (20/120 mg) twice daily, both dosed by bodyweight, orally (liquid suspension) for three days.

resultsOf 535 patients randomized, 355 received pyronaridine-artesunate and 180 received artemether-lumefantrine. Day-28 adequate clinical and parasitological response (ACPR), corrected for re-infection using polymerase chain reaction (PCR) genotyping (per-protocol population) was 97.1% (329/339; 95% CI 94.6, 98.6) for pyronaridine-artesunate; 98.8% (165/167; 95% CI 95.7, 99.9) for artemether-lumefantrine. The primary endpoint was achieved: pyronaridine-artesunate PCR-corrected day-28 ACPR was statistically significantly >90% (P < .0001). Pyronaridine-artesunate was non-inferior to artemether-lumefantrine: treatment difference -1.8% (95% CI -4.3 to 1.6). The incidence of drug-related adverse events was 37.2% (132/355) with pyronaridine-artesunate, 44.4% (80/180) with artemether-lumefantrine. Clinical biochemistry results showed similar mean changes versus baseline in the two treatment groups. From day 3 until study completion, one patient in each treatment group had peak alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN) and peak total bilirubin >2xULN (i.e. within the Hy's law definition).

conclusionsThe pyronaridine-artesunate pediatric granule formulation was efficacious and was non-inferior to artemether-lumefantrine. The adverse event profile was similar for the two comparators. Pyronaridine-artesunate should be considered for inclusion in paediatric malaria treatment programmes.

trial registrationClinicalTrials.gov: identifier NCT00541385.

Indexed as

AntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsArtesunateChildChild, PreschoolDosage FormsDrug CombinationsEthanolaminesFemaleFluorenesHumansInfantMalaria, FalciparumMaleNaphthyridinesAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsArtesunateDosage FormsDrug CombinationsEthanolaminesFluorenesNaphthyridinespyronaridineTablets

Identifiers

PMID23113947
PMCPMC3566922

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.