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

Malaria Journal

Research

Umberto D'Alessandro¹  Modest Mulenga²  Sebastian Hachizovu²  Michael Nambozi²  Mike Chaponda²  Doreen Mukwamataba²  Jean-Pierre Van Geertruyden³  David Ubben⁴ 

[1] Department Parasitology, Institute of Tropical Medicine, Antwerp, Belgium;Department of Clinical Sciences, Tropical Disease Research Center, P.O Box 71769, Ndola, Zambia;International Health Unit, Antwerp University, Universiteitsplein 1, BE-2610, Antwerpen (Wilrijk), Antwerp, Belgium;Medicines for Malaria Venture, P.O Box 1826, 20, rte de Pré-Bois, 1215, Geneva 15, Switzerland;

关键词: Malaria;    Severe Malaria;    Parasite Density;    Uncomplicated Malaria;    Lumefantrine;   

DOI  :  10.1186/1475-2875-10-50

 received in 2010-11-19, accepted in 2011-02-28,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundMalaria 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.ObjectiveThe 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.MethodsBetween 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.ResultsNo 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.ConclusionDHA/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 RegistrationISRCTN16263443, at http://www.controlled-trials.com/isrctn

【 授权许可】

CC BY   
© Nambozi et al; licensee BioMed Central Ltd. 2011