Open-label trial on efficacy of artemether/lumefantrine against the uncomplicated <em>Plasmodium falciparum</em> malaria in Metema district, Northwestern Ethiopia

Abstract

PurposeFollowing the increased Plasmodium falciparum resistance to chloroquine and sulfadoxine/pyrimethamine, Ethiopia adopted artemether/lumefantrine (AL) as the first-line treatment for uncomplicated P. falciparum in 2004. According to the recommendation of the World Health Organization, this study was carried out for regular monitoring of the efficacy of AL in treating the uncomplicated P. falciparum malaria in Metema district, Gondar Zone, Northwest Ethiopia.Patients and methodsThis is a one-arm prospective 28-day in vivo therapeutic efficacy study among the uncomplicated P. falciparum malaria patients aged 6 months and older. The study was conducted from October 2014 to January 2015, based on the revised World Health Organization protocol of 2009 for surveillance of antimalarial drug therapeutic efficacy study. Standard six-dose regimen of AL was given twice daily for 3 days, and then the treatment outcomes were assessed on days 0, 1, 2, 3, 7, 14, 21, 28, and any other unscheduled day for emergency cases.ResultsThere were 91 study subjects enrolled in this study, of whom 80 study subjects completed the full follow-up schedules and showed adequate clinical and parasitological responses on day 28, with no major adverse event. Per protocol analysis, the unadjusted cure rate of Coartem® was 98.8% (95% confidence interval: 93.3%–100%) in the study area. Recurrence of one P. falciparum case was detected on day 28, with a late parasitological failure rate of 1.2%. No early treatment failure occurred. Complete parasite and fever clearance was observed on day 3. Gametocyte carriage was 4.4% at enrollment that cleared on day 21. Although the difference is statistically not significant, a slight increase in the level of mean hemoglobin from baseline to day 28 was observed.ConclusionThe study showed high efficacy and tolerability of Coartem® against uncomplicated P. falciparum malaria, suggesting the continuation as a first-line drug in the study district. However, regular monitoring of the therapeutic efficacy of the drug, possibly with plasma drug-level measurement, is critical among the mobile border population.

Anti-malarial treatment outcomes in Ethiopia: a systematic review and meta-analysis

“…One unpublished Master’s thesis dissertation [ 36 ] was included and the rest were published in scientific journals [ 18 – 35 , 37 , 38 ]. Some 1868 patients with P. falciparum [ 21 , 23 – 27 , 30 , 31 , 34 – 38 ] and 1255 patients with P. vivax [ 18 – 20 , 22 , 28 , 29 , 32 – 35 ] were analysed with an age range between 6 months and 91 years.…”

Therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Ethiopia: a systematic review and meta-analysis

“… November 2007 and January 2008 28 day 90 NR 9 Kinfu G. et al (2012) [ 35 ] single arm, open label Prospective cohort study Tumuga health center Alamata district, Tigrai regional state, North Ethiopia August–November 2009. 28 days 71 > 6 months old 10 Wudneh F. et al (2016) [ 36 ] one-arm prospective open label trial Gendewuha (Metema) Health Center, NW ethiopia October 2014 to January 2015 28-day 91 > 6 months old …”

Transmission dynamics of co-endemic Plasmodium vivax and P. falciparum in Ethiopia and prevalence of antimalarial resistant genotypes

“…falciparum in 2004 in response to increased resistance to CQ and SP [ 2 ]. Unlike the Greater Mekong Subregion of SE Asia where delayed ACTs response has been reported, AL is shown to be highly effective in clearing parasite and fever within three days of drug treatment in Ethiopia [ 92 ]. The high efficacy of AL concords with our finding of predominantly wild type pfK13 genotypes in P .…”