Open-label trial with artemether-lumefantrine against uncomplicated Plasmodium falciparum malaria three years after its broad introduction in Jimma Zone, Ethiopia

Malaria Journal

Research

Sintayehu Fekadu¹  Thomas Löscher²  Teferi Eshetu³  Michael Pritsch⁴  Nicole Berens-Riha⁴  Nasir Abdo⁵  Kunuz H Bedru⁵  Andreas Wieser⁶ 

[1] Department of Internal Medicine, Jimma University (JU), Jimma, Ethiopia;Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich (LMU), Leopoldstrasse 5, 80802, Munich, Germany;Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich (LMU), Leopoldstrasse 5, 80802, Munich, Germany;Department of Medical Laboratory Sciences and Pathology, Jimma University (JU), Jimma, Ethiopia;Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich (LMU), Leopoldstrasse 5, 80802, Munich, Germany;German Centre for Infection Research (DZIF) at LMU, Munich, Germany;Jimma Zone Health Bureau, Jimma, Ethiopia;Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Munich, Germany;

关键词: Malaria;    Plasmodium falciparum;    Artemether-Lumefantrine;    ACT;    Ethiopia;   

DOI  :  10.1186/1475-2875-11-240

 received in 2012-05-31, accepted in 2012-07-23,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundIn Jimma Zone, Ethiopia, the first-line treatment of uncomplicated falciparum malaria has been changed from sulphadoxine-pyrimethamine (SP) to artemether-lumefantrine (AL) in 2006. The objective of this study was to assess the effectiveness of AL in Jimma Zone two to three years after its broad introduction.MethodsAn open-label, single-arm, 42-day study of AL against falciparum malaria was conducted in four areas with moderate transmission in Jimma Zone between November 2008 and January 2009 and between August and December 2009. Patients (one-81 years) with uncomplicated Plasmodium falciparum mono-infection were consecutively enrolled. Follow-up visits were at day 2, 3, 7, 28 and 42 or any other day if symptoms reoccurred. Primary and secondary endpoints were PCR-corrected and uncorrected cure rates (molecular differentiation between recrudescence and re-infection) on days 28 and 42. Other secondary endpoints were gametocytaemia at day 7 and day 28, parasitaemia at day 2 and 3, and re-infection rates at day 28 and day 42.ResultsOf 348 enrolled patients, 313 and 301 completed follow-up at day 28 and at day 42, respectively. No early treatment failure occurred. For per protocol analysis, PCR-uncorrected cure rates at day 28 and 42 were 99.1% (95% CI 98.0-100.0) and 91.1% (95% CI 87.9-94.3), respectively. PCR-corrected cure rates at day 28 and 42 were 99.4% (95% CI 98.5-100.0) and 94.7% (95% CI 92.2-97.2), respectively. PCR-corrected cure rate at day 42 for children ≤5 years was 90.6% (95% CI 82.4-98.7) only. Adverse events were in general mild to moderate. Incidence of new infections was 3.4% during 42 days, no new infections with Plasmodium vivax were observed. Microscopically detected gametocytaemia was reduced by 80% between day 0 and day 7.ConclusionIn general, AL was effective and well tolerated in Jimma Zone, Ethiopia. However, the PCR-corrected recrudescence rate per-protocol at day 42 for children ≤5 years was 9.4%. Therefore, further development should be monitored on a regular basis as recommended by WHO.

【 授权许可】

Unknown   
© Eshetu et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.