Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up

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dc.contributor.author Adjei, G.O.
dc.contributor.author Kurtzhals, J.A.L.
dc.contributor.author Rodrigues, O.P.
dc.contributor.author Alifrangis, M.
dc.contributor.author Hoegberg, L.C.G.
dc.contributor.author Kitcher, E.D.
dc.contributor.author Badoe, E.V.
dc.contributor.author Lamptey, R.
dc.contributor.author Goka, B.Q.
dc.date.accessioned 2014-08-14T13:39:37Z
dc.date.available 2014-08-14T13:39:37Z
dc.date.issued 2008-07-11
dc.identifier.uri http://197.255.68.203/handle/123456789/5638
dc.description.abstract Abstract Background Artesunate-amodiaquine (AS+AQ) and artemether-lumefantrine (AM-L) are efficacious artemisinin combination therapy (ACT) regimens that have been widely adopted in sub-Saharan Africa. However, there is little information on the efficacy of these regimens on subsequent episodes beyond 28 days, or on the safety of repeated treatments. Methods Children aged six months to 14 years with uncomplicated malaria were randomly assigned to treatment with AS+AQ (n = 116), or AM-L (n = 111). Recruited subjects were followed-up, initially for 28 days, and then monthly for up to one year. All subsequent attacks of uncomplicated malaria after 28 days were treated with the same regimen as at randomization. Investigations aimed at determining efficacy and side effects were conducted. Results Adequate clinical and parasitological response in subjects with evaluable end-points were, 97.1% (100/103) and 98.2% (107/109) on day 14, and 94.2% (97/103) and 95.3% (102/107) on day 28 in the AM-L and AS+AQ groups, respectively. Similar results were obtained after PCR correction. The incidence of malaria attacks in the year following recruitment was similar between the two treatment groups (p = 0.93). There was a high incidence of potentially AQ-resistant parasites in the study area. The incidence of adverse events, such as pruritus, fatigue and neutropaenia were similar in the two treatment groups. No patient showed signs of hearing impairment, and no abnormal neurological signs were observed during one year of follow-up. Other adverse events were mild in intensity and overlapped with known malaria symptomatology. No adverse event exacerbation was observed in any of the subjects who received multiple treatment courses with these ACT regimens during one year follow-up. Conclusion AS+AQ and AM-L were efficacious for treatment of children with uncomplicated malaria in Ghana and drug-related adverse events were rare in treated subjects during one year of follow-up. The high prevalence of potentially AQ resistant parasites raises questions about the utility of AQ as a partner drug for ACT in Ghana. The efficacy of AS+AQ in Ghana requires, therefore, continuous monitoring and evaluation. Trial registration NCT 00406146 http://www.clinicaltrials.gov
dc.title Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up
dc.type Journal Article
dc.date.updated 2014-08-14T13:39:49Z
dc.description.version Peer Reviewed
dc.language.rfc3066 en
dc.rights.holder George O Adjei et al.; licensee BioMed Central Ltd.


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