A randomized trial of artesunate-amodiaquine versus artemether-lumefantrine in Ghanaian paediatric sickle cell and non-sickle cell disease patients with acute uncomplicated malaria

Malaria Journal

Research

Jorgen A Kurtzhals¹  Insaf Khalil¹  Michael Alifrangis¹  George O Adjei²  Abdul M Sulley²  Lorna Renner³  Bamenla Q Goka³  Christabel C Enweronu-Laryea³  Onike P Rodrigues³ 

[1]Centre for Medical Parasitology at Department of International Health, Immunology and Microbiology, University of Copenhagen and Department of Clinical Microbiology and Department of Infectious Diseases, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark

[2]Centre for Tropical Clinical Pharmacology and Therapeutics, University of Ghana Medical School, College of Health Sciences, Accra, Ghana

[3]Department of Child Health, University of Ghana Medical School, College of Health Sciences, Accra, Ghana

关键词: Sickle cell disease;    Malaria;    Children;    Clinical trial;    Artemisinin combination therapy;    Ghana;   

DOI  :  10.1186/1475-2875-13-369

 received in 2014-04-09, accepted in 2014-09-12,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundSickle cell disease (SCD) is a genetic disorder common in malaria endemic areas. In endemic areas, malaria is a major cause of morbidity and mortality among SCD patients. This suggests the need for prompt initiation of efficacious anti-malarial therapy in SCD patients with acute malaria. However, there is no information to date, on the efficacy or safety of artemisinin combination therapy when used for malaria treatment in SCD patients.MethodsChildren with SCD and acute uncomplicated malaria (n = 60) were randomized to treatment with artesunate-amodiaquine (AA), or artemether-lumefantrine (AL). A comparison group of non-SCD children (HbAA genotype; n = 59) with uncomplicated malaria were also randomized to treatment with AA or AL. Recruited children were followed up and selected investigations were done on days 1, 2, 3, 7, 14, 28, 35, and 42. Selected clinical and laboratory parameters of the SCD patients were also compared with a group of malaria-negative SCD children (n = 82) in steady state.ResultsThe parasite densities on admission were significantly lower in the SCD group, compared with the non-SCD group (p = 0.0006). The parasite reduction ratio (PRR) was lower, clearance was slower (p < 0.0001), and time for initial parasitaemia to decline by 50 and 90% were longer for the SCD group. Adequate clinical and parasitological response (ACPR) on day 28 was 98.3% (58/59) in the SCD group and 100% (57/57) in the non-SCD group. Corresponding ACPR rates on day 42 were 96.5% (55/57) in the SCD group and 96.4% (53/55) in the non-SCD group. The fractional changes in haemoglobin, platelets and white blood cell counts between baseline (day 0) and endpoint (day 42) were 16.9, 40.6 and 92.3%, respectively, for the SCD group, and, 12.3, 48.8 and 7.5%, respectively, for the non-SCD group. There were no differences in these indices between AA- and AL-treated subjects.ConclusionsThe parasite clearance of SCD children with uncomplicated malaria was slower compared with non-SCD children. AA and AL showed similar clinical and parasitological effects in the SCD and non-SCD groups. The alterations in WBC and platelet counts may have implications for SCD severity.Trial registrationCurrent controlled trials ISRCTN96891086.

【 授权许可】

CC BY   
© Adjei et al.; licensee BioMed Central Ltd. 2014