Therapeutic efficacy and safety of artemether-lumefantrine combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria at Teda Health Centre, Northwest Ethiopia, 2022/23

Abstract<br> Background The emergence of Plasmodium falciparum drug resistance against artemisinin-based combination<br> therapy has threatened malaria control efforts. Since malaria control and elimination plans are dependent on these<br> drugs, they must remain efficacious. However, resistance to these drugs was detected in low-transmission settings<br> and is predicted to emerge in high-transmission settings, including in unspecified areas of Ethiopia. Therefore, this<br> study aimed to assess the therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria.<br> Methods A single-arm prospective observational study was conducted at Teda Health Centre, Northwest Ethiopia, by following the 2009 World Health Organization efficacy study guidelines from September 2022 to February<br> 2023. Patients with uncomplicated falciparum malaria were conveniently selected and treated with a standard<br> dose of artemether-lumefantrine, along with a single low dose of primaquine. Then clinical and parasitological<br> responses and haemoglobin levels were assessed during the 28-day scheduled follow-up. Blood films were examined<br> and asexual parasites were quantified; axillary temperature was measured; and drug adverse events were assessed<br> throughout the follow-up. Finally, the drug efficacy (adequate clinical and parasitological response) was determined<br> by Kaplan–Meier and per-protocol analyses. The data were analysed using the WHO Excel spreadsheet and SPSS version 25 software.<br> Results The success rates of PCR uncorrected and corrected Kaplan–Meier analysis on day 28 were 95.8% (95% CI<br> 87.5–98.6) and 97.3% (95% CI 89.4–99.3), respectively. The per-protocol PCR uncorrected and corrected adequate clinical and parasitological responses were 95.5% (95% CI 87.5–99.1) and 97% (95% CI 89.5–99.6), respectively. On day-3,<br> 97% of study participants were free of asexual parasitaemia, and all of them were fever-free on day-2. All of the gametocyte-positive patients at baseline were found to be negative for gametocytes on day-2. Moreover, the baseline<br> mean hemoglobin of 13.10 g/dl increased slightly on day-14 to 13.27 g/dl but significantly on day-28 to 13.69 g/dl<br> in a paired sample t test. All adverse events reported were mild.<br> Conclusion Artemether-lumefantrine continued to be an efficacious and safe drug for the treatment of uncomplicated Plasmodium falciparum malaria at the Teda Health Centre.<br> Trial registration: unique ID# PACTR202309773069812 at https://pactr.samrc.ac.za on September 1, 2023.<br> Keywords Efficacy, Plasmodium falciparum, Malaria, Artemether-lumefantrine, Teda