Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in mainland Tanzania, 2019

• Published in: Malaria Journal
• Main Authors: Billy E. Ngasala, Mercy G. Chiduo, Bruno P. Mmbando, Filbert T. Francis, Samwel Bushukatale, Twilumba Makene, Celine I. Mandara, Deus S. Ishengoma, Erasmus Kamugisha, Maimuna Ahmed, Muhidin K. Mahende, Reginald A. Kavishe, Florida Muro, Fabrizio Molteni, Erik Reaves, Chonge Kitojo, George Greer, Ssanyu Nyinondi, Bilal Kabula, Shabbir Lalji, Frank Chacky, Ritha J. Njau, Marian Warsame, Ally Mohamed
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2024
• Subjects: Malaria; Plasmodium falciparum; Artemether-Lumefantrine; Therapeutic efficacy; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doi.org/10.1186/s12936-024-04931-0; https://doaj.org/article/2f631baa603c4789926c93c74c105867

Abstract Background Artemisinin-based combination therapy (ACT) has been a major contributor to the substantial reductions in global malaria morbidity and mortality over the last decade. In Tanzania, artemether-lumefantrine (AL) was introduced as the first-line treatment for uncomplicated Plasmodium falciparum malaria in 2006. The World Health Organization (WHO) recommends regular assessment and monitoring of the efficacy of the first-line treatment, specifically considering that artemisinin resistance has been confirmed in the Greater Mekong sub-region. This study's main aim was to assess the efficacy and safety of AL for treating uncomplicated P. falciparum malaria in Tanzania. Methods This was a single-arm prospective antimalarial drug efficacy trial conducted in four of the eight National Malaria Control Programme (NMCP) sentinel sites in 2019. The trial was carried out in outpatient health facilities in Karume-Mwanza region, Ipinda-Mbeya region, Simbo-Tabora region, and Nagaga-Mtwara region. Children aged six months to 10 years with microscopy confirmed uncomplicated P. falciparum malaria who met the inclusion criteria were recruited based on the WHO protocol. The children received AL (a 6-dose regimen of AL twice daily for three days). Clinical and parasitological parameters were monitored during follow-up over 28 days to evaluate drug efficacy. Results A total of 628 children were screened for uncomplicated malaria, and 349 (55.6%) were enrolled between May and September 2019. Of the enrolled children, 343 (98.3%) completed the 28-day follow-up or attained the treatment outcomes. There were no early treatment failures; recurrent infections during follow-up were common at two sites (Karume 29.5%; Simbo 18.2%). PCR-corrected adequate clinical and parasitological response (ACPR) by survival analysis to AL on day 28 of follow-up varied from 97.7% at Karume to 100% at Ipinda and Nagaga sites. The commonly reported adverse events were cough, skin pallor, and abdominal pain. The drug was well tolerated, and no ...