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Title: Improving the radical cure of vivax malaria (IMPROV): A study protocol for a multicentre randomised, placebo-controlled comparison of short and long course primaquine regimens
Authors: Tesfay Abreha
Bereket Alemayehu
Ashenafi Assefa
Ghulam Rahim Awab
J. Kevin Baird
Beay Bezabih
Phaik Yeong Cheah
Nicholas P. Day
Angela Devine
Mehul Dorda
Arjen M. Dondorp
Samuel Girma
Tran Tinh Hien
Daddi Jima
Moges Kassa
Amha Kebende
Naw Htee Khu
Toby Leslie
Benedikt Ley
Yoel Lubell
Ismail Mayan
Zenebe Meaku
Ayodhia P. Pasaribu
Nguyen Hoan Phu
Ric N. Price
Julie A. Simpson
Hiwot Solomon
Inge Sutanto
Yehualahet Tadesse
Bob Taylor
Ngo Viet Thanh
Kamala Thriemer
Lorenz von Seidlein
Nicholas White
Adugna Woyessa
Prayoon Yuentrakul
Rohullah Zekria
Columbia University Mailman School of Public Health
Columbia University Medical Center
Ethiopian Public Health Institute
Nangarhar Medical Faculty of Nangarhar University
Eijkman-Oxford Clinical Research Unit
Nuffield Department of Clinical Medicine
Amhara Regional Health Bureau
Mahidol University
Worldwide Antimalarial Resistance Network (WWARN)
London School of Hygiene & Tropical Medicine
Health Protection and Research Organization
Menzies School of Health Research
Universitas Sumatera Utara
University of Melbourne
Federal Ministry of Health - Ethiopia
Universitas Indonesia
Keywords: Medicine
Issue Date: 7-Dec-2015
Citation: BMC Infectious Diseases. Vol.15, No.1 (2015)
Abstract: © 2015 The IMPROV Study Group. Background: Plasmodium vivax malaria is a major cause of morbidity and recognised as an important contributor to mortality in some endemic areas. The current recommended treatment regimen for the radical cure of P. vivax includes a schizontocidal antimalarial, usually chloroquine, combined with a 14 day regimen of primaquine. The long treatment course frequently results in poor adherence and effectiveness. Shorter courses of higher daily doses of primaquine have the potential to improve adherence and thus effectiveness without compromising safety. The proposed multicentre randomised clinical trial aims to provide evidence across a variety of endemic settings on the safety and efficacy of high dose short course primaquine in glucose-6-phosphate-dehydrogenase (G6PD) normal patients. Design: This study is designed as a placebo controlled, double blinded, randomized trial in four countries: Indonesia, Vietnam, Afghanistan and Ethiopia. G6PD normal patients diagnosed with vivax malaria are randomized to receive either 7 or 14 days high dose primaquine or placebo. G6PD deficient (G6PDd) patients are allocated to weekly primaquine doses for 8 weeks. All treatment is directly observed and recurrent episodes are treated with the same treatment than allocated at the enrolment episode. Patients are followed daily until completion of treatment, weekly until 8 weeks and then monthly until 1 year after initiation of the treatment. The primary endpoint is the incidence rate (per person year) of symptomatic recurrent P. vivax parasitaemia over 12 months of follow-up, for all individuals, controlling for site, comparing the 7 versus 14-day primaquine treatment arms. Secondary endpoints are other efficacy measures such as incidence risk at different time points. Further endpoints are risks of haemolysis and severe adverse events. Discussion: This study has been approved by relevant institutional ethics committees in the UK and Australia, and all participating countries. Results will be disseminated to inform P. vivax malaria treatment policy through peer-reviewed publications and academic presentations. Findings will contribute to a better understanding of the risks and benefits of primaquine which is crucial in persuading policy makers as well as clinicians of the importance of radical cure of vivax malaria, contributing to decreased transmission and a reduce parasite reservoir. Trial registration: Identifier: NCT01814683. Registered March 18, 2013
ISSN: 14712334
Appears in Collections:Scopus 2011-2015

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