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Title: Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): An open-label, randomised trial
Authors: Arjen M. Dondorp
Caterina I. Fanello
Ilse Ce Hendriksen
Ermelinda Gomes
Amir Seni
Kajal D. Chhaganlal
Kalifa Bojang
Rasaq Olaosebikan
Nkechinyere Anunobi
Kathryn Maitland
Esther Kivaya
Tsiri Agbenyega
Samuel Blay Nguah
Jennifer Evans
Samwel Gesase
Catherine Kahabuka
George Mtove
Behzad Nadjm
Jacqueline Deen
Juliet Mwanga-Amumpaire
Margaret Nansumba
Corine Karema
Noella Umulisa
Aline Uwimana
Olugbenga A. Mokuolu
Olanrewaju T. Adedoyin
Wahab Br Johnson
Antoinette K. Tshefu
Marie A. Onyamboko
Tharisara Sakulthaew
Wirichada Pan Ngum
Kamolrat Silamut
Kasia Stepniewska
Charles J. Woodrow
Delia Bethell
Bridget Wills
Martina Oneko
Tim E. Peto
Lorenz Von Seidlein
Nicholas Pj Day
Nicholas J. White
Hospital Central da Beira
Medical Research Council Laboratories Gambia
I/C Komfo Anokye Hosp.
Kilifi District Hospital
Magunga District Hospital
Teule Designated District Hospital
NIMR-Amani Centre
Ministry of Health
University of Ilorin
Mbarara University of Science and Technology
Kinshasa School of Public Health-Kingasani Research Centre
Mahidol University
Nuffield Department of Clinical Medicine
Menzies School of Health Research
Oxford University Clinical Research Unit
Keywords: Medicine
Issue Date: 13-Nov-2010
Citation: The Lancet. Vol.376, No.9753 (2010), 1647-1657
Abstract: Severe malaria is a major cause of childhood death and often the main reason for paediatric hospital admission in sub-Saharan Africa. Quinine is still the established treatment of choice, although evidence from Asia suggests that artesunate is associated with a lower mortality. We compared parenteral treatment with either artesunate or quinine in African children with severe malaria. This open-label, randomised trial was undertaken in 11 centres in nine African countries. Children (<15 years) with severe falciparum malaria were randomly assigned to parenteral artesunate or parenteral quinine. Randomisation was in blocks of 20, with study numbers corresponding to treatment allocations kept inside opaque sealed paper envelopes. The trial was open label at each site, and none of the investigators or trialists, apart from for the trial statistician, had access to the summaries of treatment allocations. The primary outcome measure was in-hospital mortality, analysed by intention to treat. This trial is registered, number ISRCTN50258054. 5425 children were enrolled; 2712 were assigned to artesunate and 2713 to quinine. All patients were analysed for the primary outcome. 230 (8·5) patients assigned to artesunate treatment died compared with 297 (10·9) assigned to quinine treatment (odds ratio [OR] stratified for study site 0·75, 95 CI 0·63-0·90; relative reduction 22·5, 95 CI 8·1-36·9; p=0·0022). Incidence of neurological sequelae did not differ significantly between groups, but the development of coma (65/1832 [3·5] with artesunate vs 91/1768 [5·1] with quinine; OR 0·69 95 CI 0·49-0·95; p=0·0231), convulsions (224/2712 [8·3] vs 273/2713 [10·1]; OR 0·80, 0·66-0·97; p=0·0199), and deterioration of the coma score (166/2712 [6·1] vs 208/2713 [7·7]; OR 0·78, 0·64-0·97; p=0·0245) were all significantly less frequent in artesunate recipients than in quinine recipients. Post-treatment hypoglycaemia was also less frequent in patients assigned to artesunate than in those assigned to quinine (48/2712 [1·8] vs 75/2713 [2·8]; OR 0·63, 0·43-0·91; p=0·0134). Artesunate was well tolerated, with no serious drug-related adverse effects. Artesunate substantially reduces mortality in African children with severe malaria. These data, together with a meta-analysis of all trials comparing artesunate and quinine, strongly suggest that parenteral artesunate should replace quinine as the treatment of choice for severe falciparum malaria worldwide. The Wellcome Trust. © 2010 Elsevier Ltd.
ISSN: 01406736
Appears in Collections:Scopus 2006-2010

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