Effectiveness and safety of artemether– lumefantrine versus artesunate–amodiaquine for unsupervised treatment of uncomplicated falciparum malaria in patients of all age groups in Nanoro, Burkina Faso: a randomized open label trial
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Date
2015
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BioMed Central
Abstract
Background: Several studies have reported high efficacy and safety of artemisinin-based combination therapy (ACT)
mostly under strict supervision of drug intake and limited to children less than 5 years of age. Patients over 5 years
of age are usually not involved in such studies. Thus, the findings do not fully reflect the reality in the field. This study
aimed to assess the effectiveness and safety of ACT in routine treatment of uncomplicated malaria among patients of
all age groups in Nanoro, Burkina Faso.
Methods: A randomized open label trial comparing artesunate–amodiaquine (ASAQ) and artemether–lumefantrine (AL)
was carried out from September 2010 to October 2012 at two primary health centres (Nanoro and Nazoanga) of Nanoro
health district. A total of 680 patients were randomized to receive either ASAQ or AL without any distinction by age. Drug
intake was not supervised as pertains in routine practice in the field. Patients or their parents/guardians were advised on the
time and mode of administration for the 3 days treatment unobserved at home. Follow-up visits were performed on days 3, 7,
14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. PCR geno‑
typing of merozoite surface proteins 1 and 2 (msp-1, msp-2) was used to differentiate recrudescence and new infection.
Results: By day 28, the PCR corrected adequate clinical and parasitological response was 84.1 and 77.8 % respectively
for ASAQ and AL. The cure rate was higher in older patients than in children under 5 years old. The risk of re-infection
by day 28 was higher in AL treated patients compared with those receiving ASAQ (p < 0.00001). Both AL and ASAQ
treatments were well tolerated.
Conclusion: This study shows a lowering of the efficacy when drug intake is not directly supervised. This is worrying
as both rates are lower than the critical threshold of 90 % required by the WHO to recommend the use of an anti malarial drug
in a treatment policy.
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This article is published by BioMed Central.
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Citation
Sondo et al. Malar J (2015) 14:325 DOI 10.1186/s12936-015-0843-8