Abstract
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
Highlights
Malaria in Zambia remains a public health and developmental challenge, affecting mostly children under five and pregnant women
Parents of one patient in the DHA/ PQP arm withdrew consent, 3 in the DHA/PQP arm and 4 in the AL arm were excluded from the analysis after having wrongly received an anti-malarial drug during follow up in absence of a microscopically confirmed malaria infection or after vomiting twice the study medication
Considering the above challenges, the direct and indirect costs, and the lessons learnt from the current treatment policy change, DHA/PQP could be employed as rescue and/or alternative treatment to AL or as second-line treatment for patients re-attending the health facility with malaria a few weeks after receiving the first line treatment
Summary
Malaria in Zambia remains a public health and developmental challenge, affecting mostly children under five and pregnant women. AL was deployed as first line drug with remaining concerns whether sufficient health staff had been trained on its use and the risk of a vertically oriented approach as opposed to strengthening the health service provision During this transition period, between 2003 and 2005, a clinical trial carried out in Ndola on adult patients showed that AL was significantly more efficacious than SP [9]. In 2005, a study comparing dihydroartemisininpiperaquine (DHA/PQP) with AL for the treatment of uncomplicated P. falciparum malaria in children was carried out in Ndola This was part of a phase III multicentre study done, besides Zambia, in four other African countries (Burkina Faso, Kenya, Mozambique and Uganda) [10]. More detailed results of the Zambian study are presented below
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