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Safety and efficacy of dihydroartemisinin-piperaquine versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Zambian children

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dc.contributor.author Nambozi, M.
dc.contributor.author Van geertruyden, J. P.
dc.contributor.author Hachizovu, S.
dc.contributor.author Chaponda, M.
dc.contributor.author Mukwamataba, D.
dc.contributor.author Mulenga, M.
dc.contributor.author Ubben, D.
dc.contributor.author D'Alessandro, U.
dc.date.accessioned 2011-03-22T16:02:09Z
dc.date.available 2011-03-22T16:02:09Z
dc.date.issued 2011
dc.identifier.issn 1475-2875
dc.identifier.doi http://dx.doi.org/10.1186/1475-2875-10-50
dc.identifier.other ITG-N2P
dc.identifier.other ITG-PLA
dc.identifier.other PARAS
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other FTA
dc.identifier.other Electronic
dc.identifier.other UPD32
dc.identifier.uri http://hdl.handle.net/10390/6523
dc.description.abstract BACKGROUND: Malaria in Zambia remains a public health and developmental challenge, affecting mostly children under five and pregnant women. In 2002, the first-line treatment for uncomplicated malaria was changed to artemether-lumefantrine (AL) that has proved to be highly efficacious against multidrug resistant Plasmodium falciparum. OBJECTIVE: The study objective was to determine whether dihydroartemisinin-piperaquine (DHA/PQP) had similar efficacy, safety and tolerability as AL for the treatment of children with uncomplicated P. falciparum malaria in Ndola, Zambia. METHODS: Between 2005 and 2006, 304 children (6-59 months old) with uncomplicated P. falciparum were enrolled, randomized to AL (101) or DHA/PQP (203) and followed up for 42 days. Outcome of treatment was defined according to the standard WHO classification, i.e. early treatment failure (ETF), late clinical failure (LCF, late parasitological failure (LPF) and adequate clinical and parasitological response (ACPR). Recurrent infections were genotyped to distinguish between recrudescence and new infection. RESULTS: No ETF was observed. At day 28, PCR-uncorrected ACPR was 92% in the DHA/PQP and 74% in the AL arm (OR: 4.05; 95%CI: 1.89-8.74; p<0.001). Most failure were new infections and PCR-corrected ACPR was similar in the two study arms (OR: 0.69; 95%CI: 0.22-2.26; p=0.33). Similar results were observed for day 42, i.e. higher PCR-uncorrected ACPR for DHA/PQP, mainly due to the difference observed up to day 28, while the PCR-corrected ACPR was similar: DHA/PQP: 93% (179/192), AL: 93% (84/90), (OR: 0.92; 95%CI: 0.30-2.64; p=0.85). Except for cough, more frequent in the DHA/PQP arm (p=0.04), there were no differences between treatment arms in the occurrence of adverse events. Two serious adverse events were probably associated to AL treatment. CONCLUSION: DHA/PQP was as efficacious, safe and well tolerated in treatment of uncomplicated malaria as AL, though in the latter group more new infections during the follow up were observed. DHA/PQP seems a potential candidate to be used as an alternative first-line or rescue treatment in Zambia. Trial Registration: ISRCTN16263443, at http://www.controlled-trials.com/isrctn. en
dc.language English en
dc.subject Protozoal diseases en
dc.subject Malaria en
dc.subject Plasmodium falciparum en
dc.subject Vectors en
dc.subject Mosquitoes en
dc.subject Anopheles en
dc.subject Treatment en
dc.subject Multidrug therapy en
dc.subject Dihydroartemisinin-piperaquine en
dc.subject Artemether-lumefantrine en
dc.subject Children en
dc.subject Treatment outcome en
dc.subject Tolerance en
dc.subject Safety en
dc.subject Efficacy en
dc.subject Follow-up en
dc.subject Adverse effects en
dc.subject Laboratory techniques and procedures en
dc.subject Randomized clinical trials en
dc.subject Zambia en
dc.subject Africa, Southern en
dc.title Safety and efficacy of dihydroartemisinin-piperaquine versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Zambian children en
dc.type Article-E en
dc.citation.issue 50 en
dc.citation.jtitle Malaria Journal en
dc.citation.volume 10 en
dc.citation.pages 1-9 en
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/21352609
dc.citation.jabbreviation Malar J en


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