Abstract
BackgroundArtemether/Lumefantrine (Coartem®) has been used as a first-line treatment for uncomplicated Plasmodium falciparum infection since 2004 in Ethiopia. In the present study the therapeutic efficacy of artemether/lumefantrine for the treatment of uncomplicated P. falciparum infection at Kersa, Jima zone, South-west Ethiopia, has been assessed.MethodsA 28 day therapeutic efficacy study was conducted between November 2007 and January 2008, in accordance with the 2003 WHO guidelines. Outcomes were classified as early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF) and adequate clinical and parasitological response (ACPR).Results90 patients were enrolled and completed the 28 day follow-up period after treatment with artemether/lumefantrine. Cure rate was very high, 96.3%, with 95% CI of 0.897-0.992 (PCR uncorrected). Age-stratified data showed adequate clinical and parasitological response (ACPR) to be 100% for children under 5 and 97.4% and 87.3% for children aged 5-14, and adults, respectively. There was no early treatment failure (ETF) in all age groups. Fever was significantly cleared on day 3 (P < 0.05) and 98% of parasites where cleared on day 1 and almost all parasites were cleared on day 3. 72.5% of gametocytes were cleared on day 1, the remaining 27.5% of gametocytes were maintained up to day 3 and total clearance was observed on day 7. Hemoglobin concentration showed a slight increase with parasitic clearance (P > 0.05). No major side effect was observed in the study except the occurrence of mouth ulcers in 7% of the patients.ConclusionsThe current study proved the excellent therapeutic efficacy of artemether/lumefantrine in the study area and the value of using it. However, the proper dispensing and absorption of the drug need to be emphasized in order to utilize the drug for a longer period of time. This study recommends further study on the toxicity of the drug with particular emphasis on the development of oral ulcers in children.
Highlights
Artemether/Lumefantrine (Coartem®) has been used as a first-line treatment for uncomplicated Plasmodium falciparum infection since 2004 in Ethiopia
Subject inclusion criteria The following inclusion criteria were used for the study: Mono-infection with P. falciparum, a parasitemia level of 1000 - 100,000/μl, absence of danger signs or signs of severe and complicated malaria according to the definition given by [2] presence of axillary temperature
Exclusion criteria Patients with: (i) severe signs of malaria according to WHO criteria, which included severe anaemia defined by haemoglobin < 5 g/dl, (ii) history of allergic reactions to the study drug Coartem® (iii) concomitant presence of febrile condition with the potential to confound study outcome (Example: acute respiratory infection (ARI), measles, severe diarrhea, etc.) (iv) severe malnutrition and (v) pregnant and lactating women were not included in the study [2]
Summary
Artemether/Lumefantrine (Coartem®) has been used as a first-line treatment for uncomplicated Plasmodium falciparum infection since 2004 in Ethiopia. In the present study the therapeutic efficacy of artemether/ lumefantrine for the treatment of uncomplicated P. falciparum infection at Kersa, Jima zone, South-west Ethiopia, has been assessed. Diagnosis and treatment of cases are the most important strategies for the control and prevention of malaria. It is crucial for proper management of the disease and to prevent further complications. Coartem® is being used as the first-line drug for the treatment of uncomplicated malaria [3]. A base-line study in 2004 [4] showed that AL was a highly efficacious drug with a treatment success of 99.1% and with no report of adverse effects [4]
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