Abstract

BackgroundPlasmodium falciparum accounts for approximately 60% of malaria cases in Ethiopia and artemether–lumefantrine has been used as a first-line treatment for uncomplicated P. falciparum malaria since 2004. The aim of this study was to assess the therapeutic efficacy of artemether–lumefantrine (AL) for the treatment of uncomplicated P. falciparum malaria in north-western Ethiopia.MethodsA 28-day one-arm, prospective evaluation of the clinical and parasitological response to the first-line treatment for uncomplicated P. falciparum malaria was conducted in Enfranze Health Centre in accordance with the 2009 WHO efficacy study guidelines. Patients were treated with a 3-day course of AL and clinical and parasitological parameters were monitored over a 28-day follow-up. All data from recruited patients were imported into an electronic data base and Kaplan–Meier survival analysis was used for analysing primary [early treatment failures (ETF), late clinical failure (LCF), late parasitological failures (LPF), and adequate clinical and parasitological response (ACPR)] and secondary (PCT, GCT and FCT) outcomes.ResultsEighty patients were enrolled and all of them completed the 28-day follow-up period. The PCR-corrected cure rate was 95.0% (95% CI 87.0–98.4%) and there were two ETF, one LCF and three LPF. Two of the LPF were classified as re infections by PCR. Seventy three point seven five percent, 91.25 and 95% of patients had cleared their parasitaemia by days 1, 2, and 3, respectively, and 75, 91.25 and 96.25% of patients had cleared their fever by days 1, 2, and 3. All patients completely cleared their gametocytes by day 7.ConclusionThe relatively high cure rate, low proportion of patients still positive on day 3 as well as parasite clearance times in this study would indicate no imminent threat of artemisinin resistance development in the region. However, the threat of spreading or de novo development of artemisinin resistance warrants regular monitoring of drug efficacy throughout the region.

Highlights

  • Plasmodium falciparum accounts for approximately 60% of malaria cases in Ethiopia and artemether– lumefantrine has been used as a first-line treatment for uncomplicated P. falciparum malaria since 2004

  • Cure rate of AL against uncomplicated Plasmodium falciparum malaria The PCR-corrected cure rate by Kaplan–Meier analysis was 95.0%

  • This study suggests that with a cure rate of around 95% AL remains an efficacious treatment for uncomplicated P. falciparum malaria in the region

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Summary

Introduction

Plasmodium falciparum accounts for approximately 60% of malaria cases in Ethiopia and artemether– lumefantrine has been used as a first-line treatment for uncomplicated P. falciparum malaria since 2004. Diagnosis and prompt treatment is one of the main strategies in malaria prevention and control and it is the key to reducing morbidity and preventing mortality [8]. Efforts towards controlling malaria are greatly challenged by the increasing spread of anti-malarial drug resistance [3]. Use of ineffective anti-malarial drugs contributes to the difficulties in reducing malaria morbidity and mortality, leads to the spread of malaria to new areas, re-emergence of malaria in areas where the disease had been eliminated and it has played an important role in the occurrence and severity of epidemics [9]. Anti-malarial drug resistance is observed in P. falciparum malaria, but has been identified in P. vivax [10, 11]

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