# name
Artemisinin-Naphthoquine versus Artemether-Lumefantrine for Uncomplicated Malaria in Papua New Guinean Children: An Open-Label Randomized Trial

# metadata.dc.description.abstract[].value
BACKGROUND: Artemisinin 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 FINDINGS: An 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. CONCLUSIONS:
                Artemisinin-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 REGISTRATION: Australian New Zealand
                Clinical Trials Registry ACTRN12610000913077 Please see later in
                the article for the Editors' Summary.

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
Artemisinin-Naphthoquine versus Artemether-Lumefantrine for Uncomplicated Malaria in Papua New Guinean Children: An Open-Label Randomized Trial