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A randomised trial to assess the safety and efficacy of artemether-lumefantrine (Coartem) for the treatment of uncomplicated Plasmodium falciparum malaria in Rwanda

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dc.contributor.author Fanello, C. I. en_US
dc.contributor.author Karema, C. en_US
dc.contributor.author van Doren, W. en_US
dc.contributor.author Van Overmeir, C. en_US
dc.contributor.author Ngamije, D. en_US
dc.contributor.author D'Alessandro, U. en_US
dc.date.accessioned 2007-12-06T14:33:29Z
dc.date.available 2007-12-06T14:33:29Z
dc.date.issued 2007 en_US
dc.identifier.issn 0035-9203 en_US
dc.identifier.doi http://dx.doi.org/10.1016/j.trstmh.2006.06.010
dc.identifier.other ITG-P4B 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.identifier.uri http://hdl.handle.net/10390/143
dc.description.abstract We tested the efficacy and safety of chlorproguanil/dapsone co-administered with artesunate (CD+A) for the treatment of uncomplicated Plasmodium falciparum malaria in children compared with amodiaquine+sulfadoxine/pyrimethamine (AQ+SP) at two different sites in Rwanda. The trial was open label and 800 patients were randomly assigned to AQ+SP (n=400) or CD+A (n=400). Patients were hospitalised for 3 days and then followed-up weekly until Day 28 after treatment. Clinical and parasitological outcomes were recorded. Results showed that neither treatment was adequately efficacious. At one site, the adequate clinical and parasitological response (ACPR), PCR-adjusted, was 73.3% in the CD+A arm and 87.8% in the AQ+SP arm (P<0.001), and at the second site the ACPR, PCR-adjusted, was 70.5% in the CD+A arm and 38.1% in the AQ+SP arm (P<0.001). The combination CD+A is considered an alternative to, or replacement for, SP in Africa because CD has been shown to be effective in patients for whom SP treatment has failed and, with its short half-life, it is expected to exert less selection pressure for resistant parasites than SP. However, the results of this trial indicate that in an area of high SP resistance, CD+A may not be the best choice. [ClinicalTrials.gov identifier: NCT00461578]. 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 Drug therapy en_US
dc.subject Artemisinin combination therapies (ACT) en_US
dc.subject Artemether en_US
dc.subject Lumefantrine en_US
dc.subject Efficacy en_US
dc.subject Safety en_US
dc.subject Tolerability en_US
dc.subject Randomized clinical trials en_US
dc.subject Rwanda en_US
dc.subject Africa, Central en_US
dc.title A randomised trial to assess the safety and efficacy of artemether-lumefantrine (Coartem) for the treatment of uncomplicated Plasmodium falciparum malaria in Rwanda en_US
dc.type Article en_US
dc.citation.issue 4 en_US
dc.citation.jtitle Transactions of the Royal Society of Tropical Medicine and Hygiene en_US
dc.citation.volume 101 en_US
dc.citation.pages 344-350 en_US
dc.publisher.place Amsterdam
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/18328518
dc.identifier.url http://www.elsevier.com/locate/trstmh
dc.citation.jabbreviation Trans R Soc Trop Med Hyg en_US


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