Therapeutic Efficacy of Artemether–Lumefantrine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Shendi, Sudan: A Prospective WHO Therapeutic Efficacy Study
Afaf Ali Abdalrahim
Department of Clinical Pharmacy, Faculty of Medicine, Shendi University, Shendi, Sudan.
Osama Khedr Mansour
Department of Internal Medicine, Faculty of Medicine, Shendi University, Shendi, Sudan.
Tarig Hassan Alsanjak *
Department of Internal Medicine, Faculty of Medicine, Shendi University, Shendi, Sudan.
Waddah Sharafel-deen Mahmoud
Department of Internal Medicine, Faculty of Medicine, Shendi University, Shendi, Sudan.
Mojahed Yasir Abdalgauom
Department of Internal Medicine, Faculty of Medicine, Shendi University, Shendi, Sudan.
Amal Mohamed Mohamed Elhassan
Department of Internal Medicine, Faculty of Medicine, Shendi University, Shendi, Sudan.
*Author to whom correspondence should be addressed.
Abstract
Background: Continuous surveillance of antimalarial therapeutic efficacy is essential for the early detection of emerging drug resistance and for informing national malaria treatment policies. Artemether–lumefantrine (AL) remains the first-line treatment for uncomplicated Plasmodium falciparum malaria in Sudan; however, periodic therapeutic efficacy monitoring in accordance with World Health Organization (WHO) recommendations remains necessary.
Objective: This study evaluated the therapeutic efficacy and parasitological response of artemether–lumefantrine among adults with uncomplicated P. falciparum malaria in Shendi, Sudan.
Methods: A prospective WHO therapeutic efficacy study was conducted among 100 adults aged 18–65 years with uncomplicated P. falciparum malaria. Participants received standard weight-based artemether–lumefantrine therapy and were followed for 28 days according to WHO therapeutic efficacy guidelines. Clinical and parasitological responses were assessed on scheduled follow-up days, including Days 3, 7 and 28. The primary outcome was the uncorrected Day-28 adequate clinical and parasitological response (ACPR), because PCR genotyping was not performed to distinguish recrudescence from reinfection.
Results: All 100 enrolled participants completed the 28-day follow-up. Fever resolved rapidly after treatment, and parasite clearance was observed in most patients by Day 3; however, 17% had persistent parasitaemia on Day 3. The uncorrected Day-28 ACPR was 90.0% (95% CI: 82.4%–95.1%), whereas 10.0% experienced recurrent parasitaemia during follow-up. Because PCR genotyping was not performed, recurrent infections could not be classified as recrudescence or reinfection.
Conclusions: Artemether–lumefantrine demonstrated a 90% uncorrected Day-28 therapeutic response in this study population. However, treatment efficacy should be interpreted cautiously because PCR correction was unavailable and persistent Day-3 parasitaemia was observed in a proportion of patients. Continued therapeutic efficacy surveillance, including molecular genotyping in accordance with WHO recommendations, is warranted to monitor antimalarial drug performance and detect early signals of emerging resistance.
Keywords: Artemether–lumefantrine, Plasmodium falciparum, uncomplicated malaria, therapeutic efficacy, adequate clinical and parasitological response, parasitaemia clearance, antimalarial resistance, PCR correction, Sudan, WHO therapeutic efficacy study.