Evidence map›Paper›PMID 21267072›Full record

Trial reportPloS one2011

Pyronaridine-artesunate versus chloroquine in patients with acute Plasmodium vivax malaria: a randomized, double-blind, non-inferiority trial.

Yi Poravuth, Duong Socheat, Ronnatrai Rueangweerayut, Chirapong Uthaisin, Aung Pyae Phyo, Neena Valecha, B H Krishnamoorthy Rao, Emiliana Tjitra, Asep Purnama, Isabelle Borghini-Fuhrer and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00440999 (A Phase III Comparative), which is not on this map. Cited by 56 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 9 pooled it
11.3field-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.

NCT00440999 phase3completednot on this map

A Phase III Comparative (Double-blind, Double-dummy) Randomised Multicentre Study to Assess the Safety & Efficacy of Oral Pyronaridine Artesunate (180:60 mg) Versus Chloroquine (155 mg) in Children & Adult Patients With Acute Vivax Malaria

TypeinterventionalSponsorMedicines for Malaria VentureRan2007 to 2008Enrolled456ConditionsMalariaArmsPyronaridine artesunate, Chloroquine
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 9 syntheses or guidelines pooled it, 107 citations in OpenAlex.

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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

13 authors at 9 institutions in 7 countries.

Yi PoravuthNational Malaria Center, Phnom Penh, Cambodia.
Duong Socheat
Ronnatrai Rueangweerayut
Chirapong Uthaisin
Aung Pyae Phyo
Neena Valecha
B H Krishnamoorthy Rao
Emiliana Tjitra
Asep Purnama
Isabelle Borghini-Fuhrer
Stephan Duparc
Chang-Sik Shin
Lawrence Fleckenstein
Cambodia National Malaria Center · KHMedicines for Malaria Venture · CHKasturba Medical College, MangaloreMaesot General Hospital · THMinistry of Health · IDNational Institute of Malaria Research · INShin Poong Pharm (South Korea) · KRShoklo Malaria Research Unit · THUniversity of Iowa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. METHODS AND

findingsThis phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3-≤ 60 years) with microscopically confirmed P. vivax mono-infection were randomized (1:1) to receive pyronaridine-artesunate (target dose 7.2:2.4 mg/kg to 13.8:4.6 mg/kg) or chloroquine (standard dose) once daily for three days. Each treatment group included 228 randomized patients. Outcomes for the primary endpoint, Day-14 cure rate in the per-protocol population, were 99.5%, (217/218; 95%CI 97.5, 100) with pyronaridine-artesunate and 100% (209/209; 95%CI 98.3, 100) with chloroquine. Pyronaridine was non-inferior to chloroquine: treatment difference -0.5% (95%CI -2.6, 1.4), i.e., the lower limit of the 2-sided 95%CI for the treatment difference was greater than -10%. Pyronaridine-artesunate cure rates were non-inferior to chloroquine for Days 21, 28, 35 and 42. Parasite clearance time was shorter with pyronaridine-artesunate (median 23.0 h) versus chloroquine (32.0 h; p<0.0001), as was fever clearance time (median 15.9 h and 23.8 h, respectively; p = 0.0017). Kaplan-Meier estimates of post-baseline P. falciparum infection incidence until Day 42 were 2.5% with pyronaridine-artesunate, 6.1% with chloroquine (p = 0.048, log-rank test). Post-baseline P. vivax or P. falciparum infection incidence until Day 42 was 6.8% and 12.4%, respectively (p = 0.022, log rank test). There were no deaths. Adverse events occurred in 92/228 (40.4%) patients with pyronaridine-artesunate and 72/228 (31.6%) with chloroquine. Mild and transient increases in hepatic enzymes were observed for pyronaridine-artesunate.

conclusionPyronaridine-artesunate efficacy in acute uncomplicated P. vivax malaria was at least that of chloroquine. As pyronaridine-artesunate is also efficacious against P. falciparum malaria, this combination has potential utility as a global antimalarial drug.

trial registrationClinicaltrials.gov NCT00440999.

Indexed as

AdolescentAdultAntimalarialsArtemisininsArtesunateChildChild, PreschoolChloroquineDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleFeverHumansMalaria, VivaxMaleMiddle AgedAntimalarialsArtemisininsArtesunateChloroquineNaphthyridinespyronaridine

Identifiers

PMID21267072
PMCPMC3022577
OpenAlexW1990484619

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.