Safety and efficacy of artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in Ethiopia.

OBJECTIVE: To document baseline data on the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Ethiopia. DESIGN: Patients diagnosed for P. falciparum, who were treated with six doses of artemether-lumefantrine over three days, were followed for 28 days and treatment outcomes classified based on the WHO (2003) protocol. SETTING: Four health facilities located in malarious areas in two regions: Alamata and Humera hospitals in Tigray region and Assendabo and Nazareth in Oromia region. SUBJECTS: Patients with body weight of more than 10 kgs, excluding pregnant women, who or their guardians consented to participate in the study after fulfilling the inclusion criteria were enrolled in the study for a follow-up period of 28 days. MAIN OUTCOME MEASURES: Proportion of treatment success and adverse drug effects that required discontinuation of treatment and/or follow-up. RESULTS: A total of 213 patients who fulfilled the enrolment criteria completed the 28 days follow-up after treatment with artemether-lumefantrine. A treatment success rate of 99.1% (95% confidence interval [CI] 96.9, 99.8) and no adverse effects or complaints related to the drug that required discontinuation of treatment or withdrawal from follow-up was reported. Treatment success was not achieved in 213 (0.9%) subjects for whom fever and peripheral parasitaemia was demonstrated on day 21 and 28. The day 21 and day 28 blood samples of the treatment failure cases were not PCR corrected. CONCLUSION: The artemisinin based combination drug artemether-lumefantrine has shown very high (99.1%) clinical and parasitological cure for the treatment of uncomplicated falciparum malaria with no reports of adverse reaction that required withdrawal of treatment or discontinuation of follow-up. In the presence of the low efficacy of sulfadoxine-pyrimethamine, chloroquine and amodiaquine, the use of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria is the best choice for Ethiopia.

Efficacy of sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in Ethiopia.

OBJECTIVE: To assess the status of the therapeutic efficacy of sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria to enable evidence based policy decisions. DESIGN: The study used the new WHO (2003) protocol for the assessment of the therapeutic efficacy of anti-malarial drugs. SETTING: Eleven health facilities located in malarious areas with seasonal transmission. SUBJECTS: Patients aged six months and above who presented to the health facilities for febrile illness and for whom consent was obtained to participate in the study after fulfilling the inclusion criteria were enrolled in the study. MAIN OUTCOME MEASURES: Proportion of treatment failures. RESULTS: In eleven (90.9%) of the sites, where adequate sample was collected, a total of 598 subjects were enrolled and 487 (81.4%) completed the follow-up. A mean treatment failure rate of 35.9% (95% confidence interval [CI] 31.8, 40.3) on the 14 days follow-up and 71.7% (95% CI 67.5, 75.9) on the 28-days follow-up was recorded (not PCR corrected). The mean clinical failure on the 14-days follow-up was 20.9% (95% CI 17.5, 24.7) and 70% (n=10) sites had aggregated clinical failure rates higher than 15%, while in 80% (n=10) sites the total treatment failure exceeded 25%. There was no significant difference in treatment failure rates in areas with malaria transmission duration of six months and above as compared to areas with below six months of transmission (odds ratio [OR] = 0.9, 95% CI 0.43,1.83 p = 0.75). The difference in mean treatment failure between the <5 and > or =15 years of age was not significant (OR 0.8, 95% CI 0.39,1.67 P = 0.54). CONCLUSION: The level of treatment failure detected is much higher than the WHO recommended tolerable levels. The findings, therefore, strongly indicate the need for an immediate review of the existing national anti-malarial treatment guideline.

Malaria epidemics in the highlands of Ethiopia.

OBJECTIVE: To confirm the occurrence and describe the patterns of the 2003 malaria epidemics reported in the highlands of Ethiopia. DESIGN: A retrospective descriptive study. SETTINGS: Fifty epidemic affected districts between altitude ranges of 1500 and 2500 m in three regions in Ethiopia. RESULTS: Exaggerated seasonal transmission was observed in 25 districts, 16 in Oromia region and 9 in SNNPR. A sustained upward trend with 3-4 consecutive abnormal seasonal transmissions, which has started since 2002, has been identified in 22 districts. True explosive epidemic malaria was recorded at exceptionally high altitude (around 2500m) in at least one of the health facilities in seven districts. The incidence of malaria in 2003 epidemic has showed a six fold increase on average (range 2-20) from the threshold level. CONCLUSION: Occurrence of a malaria epidemic was confirmed in all studied districts showing that the level of malaria endemicity and magnitude of the problem is increasing. The findings suggest the strategic importance of taking well-timed and appropriately targeted preventive and control interventions.