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

Malaria Journal

Research

Odile Zampa¹  Tinga Robert Guiguemde¹  Zekiba Tarnagda²  Paul Sondo²  Hermann Sorgho²  Jean-Bosco Ouedraogo²  Karim Derra²  Seydou Diallo-Nakanabo²  Adama Kazienga²  Halidou Tinto³  Innocent Valea³  Ellis Owusu-Dabo⁴ 

[1] Centre Muraz of Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso;IRSS, Clinical Research Unit of Nanoro (CRUN), CMA Saint Camille of Nanoro, BP 218 Ouagadougou CMS 11, Nanoro, Burkina Faso;IRSS, Clinical Research Unit of Nanoro (CRUN), CMA Saint Camille of Nanoro, BP 218 Ouagadougou CMS 11, Nanoro, Burkina Faso;Centre Muraz of Bobo-Dioulasso, Bobo-Dioulasso, Burkina Faso;Kumasi Center for Collaborative Research in Tropical Medicine (KCCR), Kumasi, Ghana;

关键词: Effectiveness;    Artesunate–amodiaquine;    Artemether–lumefantrine;    Unsupervised-treatment;    Malaria;   

DOI  :  10.1186/s12936-015-0843-8

 received in 2015-05-06, accepted in 2015-08-10,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundSeveral 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.MethodsA 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 genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) was used to differentiate recrudescence and new infection.ResultsBy 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.ConclusionThis 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.Trial registration: NCT01232530

【 授权许可】

CC BY   
© Sondo et al. 2015