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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/51415
Title: Short-course primaquine for the radical cure of Plasmodium vivax malaria: a multicentre, randomised, placebo-controlled non-inferiority trial
Authors: Walter R.J. Taylor
Kamala Thriemer
Lorenz von Seidlein
Prayoon Yuentrakul
Thanawat Assawariyathipat
Ashenafi Assefa
Sarah Auburn
Krisin Chand
Nguyen Hoang Chau
Phaik Yeong Cheah
Le Thanh Dong
Mehul Dhorda
Tamiru Shibru Degaga
Angela Devine
Lenny L. Ekawati
Fahmi Fahmi
Asrat Hailu
Mohammad Anwar Hasanzai
Tran Tinh Hien
Htee Khu
Benedikt Ley
Yoel Lubell
Jutta Marfurt
Hussein Mohammad
Kerryn A. Moore
Mohammad Nader Naddim
Ayodhia Pitaloka Pasaribu
Syahril Pasaribu
Cholrawee Promnarate
Awab Ghulam Rahim
Pasathron Sirithiranont
Hiwot Solomon
Herawati Sudoyo
Inge Sutanto
Ngo Viet Thanh
Nguyen Thi Tuyet-Trinh
Naomi Waithira
Adugna Woyessa
Fazal Yamin Yamin
Arjen Dondorp
Julie A. Simpson
J. Kevin Baird
Nicholas J. White
Nicholas P. Day
Ric N. Price
Melbourne School of Population and Global Health
Arba Minch University
Federal Ministry of Health - Ethiopia
Addis Ababa University
Universitas Sumatera Utara
Eijkman Institute for Molecular Biology
Universitas Indonesia
Menzies School of Health Research
UCL
Mahidol University
Nuffield Department of Clinical Medicine
Burnet Institute
Krong-Pa Health Centre
Ethiopian Public Health Institute
Nangarhar University
Eijkman Institute of Molecular Biology
Health Protection and Research Organisation
Health and Social Development Organization
Institute of Malariology, Parasitology and Entomology
Keywords: Medicine
Issue Date: 14-Sep-2019
Citation: The Lancet. Vol.394, No.10202 (2019), 929-938
Abstract: © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: Primaquine is the only widely used drug that prevents Plasmodium vivax malaria relapses, but adherence to the standard 14-day regimen is poor. We aimed to assess the efficacy of a shorter course (7 days) of primaquine for radical cure of vivax malaria. Methods: We did a randomised, double-blind, placebo-controlled, non-inferiority trial in eight health-care clinics (two each in Afghanistan, Ethiopia, Indonesia, and Vietnam). Patients (aged ≥6 months) with normal glucose-6-phosphate dehydrogenase (G6PD) and presenting with uncomplicated vivax malaria were enrolled. Patients were given standard blood schizontocidal treatment and randomly assigned (2:2:1) to receive 7 days of supervised primaquine (1·0 mg/kg per day), 14 days of supervised primaquine (0·5 mg/kg per day), or placebo. The primary endpoint was the incidence rate of symptomatic P vivax parasitaemia during the 12-month follow-up period, assessed in the intention-to-treat population. A margin of 0·07 recurrences per person-year was used to establish non-inferiority of the 7-day regimen compared with the 14-day regimen. This trial is registered at ClinicalTrials.gov (NCT01814683). Findings: Between July 20, 2014, and Nov 25, 2017, 2336 patients were enrolled. The incidence rate of symptomatic recurrent P vivax malaria was 0·18 (95% CI 0·15 to 0·21) recurrences per person-year for 935 patients in the 7-day primaquine group and 0·16 (0·13 to 0·18) for 937 patients in the 14-day primaquine group, a difference of 0·02 (−0·02 to 0·05, p=0·3405). The incidence rate for 464 patients in the placebo group was 0·96 (95% CI 0·83 to 1·08) recurrences per person-year. Potentially drug-related serious adverse events within 42 days of starting treatment were reported in nine (1·0%) of 935 patients in the 7-day group, one (0·1%) of 937 in the 14-day group and none of 464 in the control arm. Four of the serious adverse events were significant haemolysis (three in the 7-day group and one in the 14-day group). Interpretation: In patients with normal G6PD, 7-day primaquine was well tolerated and non-inferior to 14-day primaquine. The short-course regimen might improve adherence and therefore the effectiveness of primaquine for radical cure of P vivax malaria. Funding: UK Department for International Development, UK Medical Research Council, UK National Institute for Health Research, and the Wellcome Trust through the Joint Global Health Trials Scheme (MR/K007424/1) and the Bill & Melinda Gates Foundation (OPP1054404).
URI: http://repository.li.mahidol.ac.th/dspace/handle/123456789/51415
metadata.dc.identifier.url: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85071980923&origin=inward
ISSN: 1474547X
01406736
Appears in Collections:Scopus 2019

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