Please use this identifier to cite or link to this item: http://docs.prosentient.com.au/prosentientjspui/handle/1/11196
Title: Efficacy of Artesunate-mefloquine for Chloroquine-resistant Plasmodium vivax Malaria in Malaysia: An Open-label, Randomized, Controlled Trial.
Authors: Grigg, Matthew J
William, Timothy
Menon, Jayaram
Barber, Bridget E
Wilkes, Christopher S
Rajahram, Giri S
Edstein, Michael D
Auburn, Sarah
Price, Ric N
Yeo, Tsin W
Anstey, Nicholas M
Affiliation: Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.. Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu..
Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu.. Clinical Research Centre, Queen Elizabeth Hospital.. Jesselton Medical Centre..
Clinical Research Centre, Queen Elizabeth Hospital.. Sabah Department of Health, Kota Kinabalu, Malaysia..
Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.. Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu..
Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.. Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu..
Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu.. Clinical Research Centre, Queen Elizabeth Hospital.. Sabah Department of Health, Kota Kinabalu, Malaysia..
Department of Drug Evaluation, Australian Army Malaria Institute, Brisbane, Queensland..
Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia..
Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.. Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, United Kingdom..
Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.. Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu.. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore..
Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.. Infectious Diseases Society Sabah-Menzies School of Health Research Clinical Research Unit, Kota Kinabalu.. Division of Medicine, Royal Darwin Hospital, Darwin, Northern Territory, Australia..
Issue Date: 2016
Citation: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2016; 62(11): 1403-1411
Abstract: Chloroquine (CQ)-resistant Plasmodium vivax is increasingly reported throughout southeast Asia. The efficacy of CQ and alternative artemisinin combination therapies (ACTs) for vivax malaria in Malaysia is unknown. A randomized, controlled trial of CQ vs artesunate-mefloquine (AS-MQ) for uncomplicated vivax malaria was conducted in 3 district hospitals in Sabah, Malaysia. Primaquine was administered on day 28. The primary outcome was the cumulative risk of treatment failure by day 28 by Kaplan-Meier analysis. From 2012 to 2014, 103 adults and children were enrolled. Treatment failure by day 28 was 61.1% (95% confidence interval [CI], 46.8-75.6) after CQ and 0% (95% CI, 0-.08) following AS-MQ (P < .001), of which 8.2% (95% CI, 2.5-9.6) were early treatment failures. All patients with treatment failure had therapeutic plasma CQ concentrations at day 7. Compared with CQ, AS-MQ was associated with faster parasite clearance (normalized clearance slope, 0.311 vs 0.127; P < .001) and fever clearance (mean, 19.0 vs 37.7 hours; P =001) and with lower risk of anemia at day 28 (odds ratio = 3.7; 95% CI, 1.5-9.3; P =005). Gametocytes were present at day 28 in 23.8% (10/42) of patients following CQ vs none with AS-MQ (P < .001). AS-MQ resulted in lower bed occupancy: 4037 vs 6510 days/1000 patients (incidence rate ratio 0.62; 95% CI, .60-.65; P < .001). One patient developed severe anemia not regarded as related to their AS-MQ treatment. High-grade CQ-resistant P. vivax is prevalent in eastern Malaysia. AS-MQ is an efficacious ACT for all malaria species. Wider CQ-efficacy surveillance is needed in vivax-endemic regions with earlier replacement with ACT when treatment failure is detected.Clinical Trials Registration NCT01708876.
URI: http://docs.prosentient.com.au/prosentientjspui/handle/1/11196
DOI: 10.1093/cid/ciw121
Type: Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Subjects: Plasmodium vivax
artesunate-mefloquine
chloroquine
malaria
randomized, controlled trial
Adolescent
Adult
Aged
Antimalarials
Artemisinins
Child
Child, Preschool
Chloroquine
Female
Humans
Infant
Male
Mefloquine
Middle Aged
Treatment Outcome
Young Adult
Drug Resistance
Malaria, Vivax
Plasmodium vivax
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