An Open-Label, Randomised Study of Dihydroartemisinin-Piperaquine Versus Artesunate-Mefloquine for F

An Open-Label, - An Open-Label Randomised Study of Dihydroartemisinin-Piperaquine Versus for Falciparum Malaria in Asia Neena Valecha1 Aung Pyae

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An Open-Label, Randomised Study of Dihydroartemisinin-Piperaquine Versus Artesunate- Mefloquine for Falciparum Malaria in Asia Neena Valecha 1 * , Aung Pyae Phyo 2 , Mayfong Mayxay 3,4 , Paul N. Newton 3,5 , Srivicha Krudsood 6 , Sommay Keomany 7 , Maniphone Khanthavong 8 , Tiengkham Pongvongsa 9 , Ronnatrai Ruangveerayuth 10 , Chirapong Uthaisil 11 , David Ubben 12 , Stephan Duparc 12 , Antonella Bacchieri 13 , Marco Corsi 13 , Bappanad H. K. Rao 14 , Prabash C. Bhattacharya 15 , Nagesh Dubhashi 16 , Susanta K. Ghosh 17 , Vas Dev 18 , Ashwani Kumar 19 , Sasithon Pukittayakamee 6 1 National Institute of Malaria Research, Delhi, India, 2 Shoklo Malaria Research Unit, Tak, Thailand, 3 Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic, 4 Faculty of Postgraduate Studies and Research, University of Health Sciences, Vientiane, Lao People’s Democratic Republic, 5 Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom, 6 Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand, 7 Salavan Provincial Hospital, Salavan, Lao People’s Democratic Republic, 8 Centre of Malariology, Parasitology and Entomology, Vientiane, Lao People’s Democratic Republic, 9 Savannakhet Provincial Malaria Station, Savannakhet, Lao People’s Democratic Republic, 10 Mae Sod Hospital, Tak, Thailand, 11 Mae Ramat Hospital, Tak, Thailand, 12 Medicines for Malaria Venture, International Centre Cointrin, Geneva, Switzerland, 13 Sigma-Tau Industrie Farmaceutiche Riunite, Pomezia, Italy, 14 Wenlock District Government Hospital, Mangalore, India, 15 Down Town Hospital, Guwahati, India, 16 Department of Medicine, Goa Medical College and Hospital, Bambolim, India, 17 National Institute of Malaria Research Field Unit, Bangalore, India, 18 National Institute of Malaria Research Field Unit, Guwahati, India, 19 National Institute of Malaria Research Field Unit, Panaji, India Abstract Background: The artemisinin-based combination treatment (ACT) of dihydroartemisinin (DHA) and piperaquine (PQP) is a promising novel anti-malarial drug effective against multi-drug resistant falciparum malaria. The aim of this study was to show non-inferiority of DHA/PQP vs. artesunate-mefloquine (AS + MQ) in Asia. Methods and Findings: This was an open-label, randomised, non-inferiority, 63-day follow-up study conducted in Thailand, Laos and India. Patients aged 3 months to 65 years with Plasmodium falciparum mono-infection or mixed infection were randomised with an allocation ratio of 2:1 to a fixed-dose DHA/PQP combination tablet (adults: 40 mg/160 mg; children: 20 mg/320 mg; n = 769) or loose combination of AS + MQ (AS: 50 mg, MQ: 250 mg; n = 381). The cumulative doses of study treatment over the 3 days were of about 6.75 mg/kg of DHA and 54 mg/kg of PQP and about 12 mg/kg of AS and 25 mg/kg of MQ. Doses were rounded up to the nearest half tablet. The primary endpoint was day-63 polymerase chain reaction (PCR) genotype-corrected cure rate. Results were 87.9% for DHA/PQP and 86.6% for AS + MQ in the intention-to-treat (ITT; 97.5% one- sided confidence interval, CI: .2 2.87%), and 98.7% and 97.0%, respectively, in the per protocol population (97.5%
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This note was uploaded on 12/03/2010 for the course PHAMACOLOG pcl470 taught by Professor Arnot during the Fall '10 term at University of Toronto- Toronto.

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An Open-Label, - An Open-Label Randomised Study of Dihydroartemisinin-Piperaquine Versus for Falciparum Malaria in Asia Neena Valecha1 Aung Pyae

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