Efficacy and Saftey of Artemether-Lumefantrine with Single Dose Primaquine for Treatment of Uncomplicated Plasmodium Falciparum Malaria in Arbaminch, Southwest Ethiopia
No Thumbnail Available
Date
2024-04-13
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Addis Ababa University
Abstract
Background: In Ethiopia, 60% of the population resides in areas prone to malaria infection. The first-line treatment for uncomplicated Plasmodium falciparum (P. falciparum) infection in Ethiopia is artemether-lumefantrine (AL), as outlined in the national malaria diagnosis and treatment guideline. The World Health Organization (WHO) recommends monitoring the efficacy of first-line antimalarial drugs at least once every two years post-implementations. Such information is crucial for assessing resistance levels and implementing timely interventions.
Objective: To assess the therapeutic efficacy and safety of AL for the treatment of uncomplicated P. falciparum based on clinical, parasitological and hematological parameters.
Methods: A prospective single-arm efficacy study was conducted among adults and children ≥ 6 months confirmed with uncomplicated P. falciparum and attending outpatient care at Shecha Health Center, Arbaminch, Southwest Ethiopia. The study took place from October 2023 to January 2024, during which the participants were enrolled and followed up for 28 days to evaluate clinical and parasitological responses. Enrolled participants were treated with the standard artemether 20mg + lumefantrine 120mg tablet, administered twice daily for three consecutive days and single dose primaquine given as 0.25mg/kg based on the national malaria treatment guideline of Ethiopia and the revised WHO protocol. Baseline assessments, including standard physical examinations and recording of medical history, were conducted on day 0 before dosing. Subsequent assessments were performed on days 1, 2, 3, 7, 14, 21, and 28. Thick and thin blood smears were taken at all time-points during the 28-day follow-up to detect parasites. Hemoglobin levels were measured from finger-prick blood samples on days 0, 14, and 28 to monitor changes and classify anemia severity. P. falciparum samples underwent polymerase chain reaction (PCR) testing for merozoite surface protein-1 (msp1), merozoite surface protein 2 (msp2), and glutamate-rich protein (glurp) to compare genotypic profiles pre- and post-parasite strains, distinguishing recrudescence from newly acquired infection. The primary outcome was the cure rate of AL measured by the adequate clinical and parasitological response (ACPR) on day 28. Secondary outcomes were parasite and gametocyte clearance, fever clearance, change in hemoglobin, and incidence of drug adverse events. Kaplan-Meier survival analysis and Per-protocol analysis were used to estimate primary and secondary outcomes, with statistical analysis conducted using SPSS version 25. One-Way ANOVA was used to compare baseline parasitemia between age groups, and a paired sample t-test was used to compare mean hemoglobin levels across follow-up dates. All comparisons were made at a 95% confidence interval (CI), with a significance level set at 0.05.
Description
Keywords
Malaria Treatment EfficacySafetyArtemether-LumefantrineP. falciparum Ethiopia