Evidence map›Paper›PMID 25549086›Full record

Trial reportPLoS medicine2014

Artemisinin-naphthoquine versus artemether-lumefantrine for uncomplicated malaria in Papua New Guinean children: an open-label randomized trial.

Moses Laman, Brioni R Moore, John M Benjamin, Gumul Yadi, Cathy Bona, Jonathan Warrel, Johanna H Kattenberg, Tamarah Koleala, Laurens Manning, Bernadine Kasian and 10 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PLoS medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 6 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.

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

23 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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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

20 authors.

Moses LamanSchool of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia; Papua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Brioni R MooreSchool of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia; Papua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
John M BenjaminPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Gumul YadiPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Cathy BonaPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Jonathan WarrelPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Johanna H KattenbergPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea; Infection and Immunity Division, Walter and Eliza Hall Institute, Parkville, Victoria, Australia.
Tamarah KolealaPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Laurens ManningSchool of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia.
Bernadine KasianPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Leanne J RobinsonPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea; Infection and Immunity Division, Walter and Eliza Hall Institute, Parkville, Victoria, Australia.
Naomi SambalePapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Lina LorryPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Stephan KarlSchool of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia; Infection and Immunity Division, Walter and Eliza Hall Institute, Parkville, Victoria, Australia.
Wendy A DavisSchool of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia.
Anna Rosanas-UrgellPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Ivo MuellerInfection and Immunity Division, Walter and Eliza Hall Institute, Parkville, Victoria, Australia; Center de Recerca en Salut Internacional de Barcelona, Barcelona, Spain.
Peter M SibaPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Inoni BetuelaPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Timothy M E DavisSchool of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundArtemisinin combination therapies (ACTs) with broad efficacy are needed where multiple Plasmodium species are transmitted, especially in children, who bear the brunt of infection in endemic areas. In Papua New Guinea (PNG), artemether-lumefantrine is the first-line treatment for uncomplicated malaria, but it has limited efficacy against P. vivax. Artemisinin-naphthoquine should have greater activity in vivax malaria because the elimination of naphthoquine is slower than that of lumefantrine. In this study, the efficacy, tolerability, and safety of these ACTs were assessed in PNG children aged 0.5-5 y. METHODS AND

findingsAn open-label, randomized, parallel-group trial of artemether-lumefantrine (six doses over 3 d) and artemisinin-naphthoquine (three daily doses) was conducted between 28 March 2011 and 22 April 2013. Parasitologic outcomes were assessed without knowledge of treatment allocation. Primary endpoints were the 42-d P. falciparum PCR-corrected adequate clinical and parasitologic response (ACPR) and the P. vivax PCR-uncorrected 42-d ACPR. Non-inferiority and superiority designs were used for falciparum and vivax malaria, respectively. Because the artemisinin-naphthoquine regimen involved three doses rather than the manufacturer-specified single dose, the first 188 children underwent detailed safety monitoring. Of 2,542 febrile children screened, 267 were randomized, and 186 with falciparum and 47 with vivax malaria completed the 42-d follow-up. Both ACTs were safe and well tolerated. P. falciparum ACPRs were 97.8% and 100.0% in artemether-lumefantrine and artemisinin-naphthoquine-treated patients, respectively (difference 2.2% [95% CI -3.0% to 8.4%] versus -5.0% non-inferiority margin, p = 0.24), and P. vivax ACPRs were 30.0% and 100.0%, respectively (difference 70.0% [95% CI 40.9%-87.2%], p<0.001). Limitations included the exclusion of 11% of randomized patients with sub-threshold parasitemias on confirmatory microscopy and direct observation of only morning artemether-lumefantrine dosing.

conclusionsArtemisinin-naphthoquine is non-inferior to artemether-lumefantrine in PNG children with falciparum malaria but has greater efficacy against vivax malaria, findings with implications in similar geo-epidemiologic settings within and beyond Oceania.

trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12610000913077. Please see later in the article for the Editors' Summary.

Indexed as

AdultAntimalarialsArtemetherArtemisininsEthanolaminesFemaleFluorenesHumansLumefantrineMalaria, FalciparumMaleMiddle AgedAntimalarialsArtemetherartemisininArtemisininsEthanolaminesFluorenesLumefantrine

Identifiers

PMID25549086
PMCPMC4280121

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.