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Efficacy of artesunate plus chloroquine for uncomplicated malaria in children in Sao Tome and Principe: a double-blind, randomized, controlled trial

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Show simple item record Gil, V. S. en_US Ferreira, M. C. R. en_US d'Alva, F. S. M. en_US d'Abreu, J. A. en_US Will, I. M. en_US Gomes, M. L. en_US Castelli, F. en_US Taylor, W. R. en_US Olliaro, P. en_US D'Alessandro, U. en_US 2007-12-06T14:33:33Z 2007-12-06T14:33:33Z 2003 en_US
dc.identifier.issn 0035-9203 en_US
dc.identifier.other ITG-PLA en_US
dc.identifier.other PARAS en_US
dc.identifier.other U-MALAR en_US
dc.identifier.other JIF en_US
dc.identifier.other DOI en_US
dc.identifier.other ABSTRACT en_US
dc.description.abstract We conducted a double-blind, randomized, placebo-controlled trial in Sao Tome and Principe to investigate the safety, tolerability and efficacy of chloroquine (CQ) combined with artesunate (AS) over CQ monotherapy. Four hundred children, aged 6-59 months, with acute uncomplicated Plasmodium falciparum malaria were randomized to receive a standard dose of CQ (25 mg/kg bodyweight) over 3 d or CQ + AS (4 mg/kg bodyweight) daily for 3 d. Children were followed-up for 28 d. The combined treatment was well tolerated and there were no serious drug-related adverse events. By day 2 parasite clearance was significantly faster for children treated with CQ + AS compared with CQ alone (29/194 [14.9%] vs. 168/190 [88.4%] still parasitaemic, P< 0.0001). Day 14 parasitological failure rates were 153/191 (80.1%) for CQ alone compared with 32/193 (16.6%) in the CQ + AS group (odds ratio [OR] =20.2, 95% CI 11.7-35.4, P< 0.001). Corresponding clinical failure rates were 128/161 (67.0%) and 12/193 (6.2%) (OR = 30.6, 95% CI 15.3-62.7, P< 0.001). By day 28 the parasitological failure rates (new infections excluded) were 155/191 (81.1%) in the CQ group and 63/194 (32.4%) in the CQ + AS group (OR = 8.9, 95% CI 5.4-14.7, P< 0.001). Symptoms resolved faster in children who received AS. They were also less likely to be gametocytaemic after treatment. The combination treatment was well tolerated and considerably improved treatment efficacy. However, the current levels of CQ resistance preclude its use in Sao Tome where CQ should be abandoned as first-line drug. However, CQ + AS may be an option in areas where CQ resistance is lower. en_US
dc.language English en_US
dc.publisher Elsevier
dc.subject Protozoal diseases en_US
dc.subject Malaria en_US
dc.subject Plasmodium falciparum en_US
dc.subject Chloroquine en_US
dc.subject Drug resistance en_US
dc.subject Combination therapy en_US
dc.subject Artesunate en_US
dc.subject Treatment outcomes en_US
dc.subject Sao Tome and Principe en_US
dc.subject Africa, Central en_US
dc.subject Atlantic en_US
dc.title Efficacy of artesunate plus chloroquine for uncomplicated malaria in children in Sao Tome and Principe: a double-blind, randomized, controlled trial en_US
dc.type Article en_US
dc.citation.issue 6 en_US
dc.citation.jtitle Transactions of the Royal Society of Tropical Medicine and Hygiene en_US
dc.citation.volume 97 en_US
dc.citation.pages 703-706 en_US Amsterdam
dc.citation.jabbreviation Trans R Soc Trop Med Hyg en_US

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