Efficacy and safety of artemether-lumefantrine against uncomplicated falciparum malaria infection in Tanzania, 2022, a single arm clinical trial.

Autor: Laury JE; Public Health Institute, Oakland, CA, USA.; Division of Parasitic Diseases and Malaria, National Center for Emerging and Zoonotic Infectious Disease, Centers for Disease Control and Prevention, Atlanta, GA, USA.; US President's Malaria Initiative, U.S. Centers for Disease Control and Prevention, Atlanta, GA, USA., Mugittu K; Shinda Malaria, Ifakara Health Institute, Dar es Salaam, Tanzania., Kajeguka DC; Kilimanjaro Christian Medical University College, Moshi, Tanzania., Kamugisha E; Catholic University of Health and Allied Sciences, Bugando Medical Centre, Mwanza, Tanzania., Ishengoma DS; National Institute for Medical Research, Dar es Salaam, Tanzania., Mandara CI; National Institute for Medical Research, Dar es Salaam, Tanzania., Ngasala B; Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania., Chiduo MG; National Institute for Medical Research, Tanga Research Center, Tanga, Tanzania., Mahende MK; Shinda Malaria, Ifakara Health Institute, Dar es Salaam, Tanzania., Kitau J; World Health Organization, Country Office, P.O. Box, Dar es Salaam, Tanzania., Ahmed MM; Catholic University of Health and Allied Sciences, Bugando Medical Centre, Mwanza, Tanzania., Mkumbaye SI; Kilimanjaro Christian Medical University College, Moshi, Tanzania., Francis F; National Institute for Medical Research, Tanga Research Center, Tanga, Tanzania., Chacky F; National Malaria Control Program, Mtumba, Dodoma, Tanzania., Warsame M; Gothenburg University, Gothenburg, Sweden., Serbantez N; U.S. President's Malaria Initiative, U.S. Agency for International Development, Dar es Salaam, Tanzania., Kitojo C; U.S. President's Malaria Initiative, U.S. Agency for International Development, Dar es Salaam, Tanzania., Reaves EJ; U.S. President's Malaria Initiative, U.S. Centers for Disease Control and Prevention, Dar es Salaam, Tanzania., Bishanga DR; Shinda Malaria, Ifakara Health Institute, Dar es Salaam, Tanzania., Bajic M; Division of Parasitic Diseases and Malaria, National Center for Emerging and Zoonotic Infectious Disease, Centers for Disease Control and Prevention, Atlanta, GA, USA.; US President's Malaria Initiative, U.S. Centers for Disease Control and Prevention, Atlanta, GA, USA., Kabula BI; USAID/Okoa Maisha Dhibiti Malaria, RTI International, Dar Es Salaam, Tanzania., Muro F; Kilimanjaro Christian Medical University College, Moshi, Tanzania.; Kilimanjaro Christian Medical Centre, Moshi Tanzania., Kavishe RA; Kilimanjaro Christian Medical University College, Moshi, Tanzania.
Jazyk: angličtina
Zdroj: The Journal of infectious diseases [J Infect Dis] 2024 Aug 26. Date of Electronic Publication: 2024 Aug 26.
DOI: 10.1093/infdis/jiae425
Abstrakt: Background: Artemether-lumefantrine (AL) is the first line anti-malarial drug for the treatment of uncomplicated malaria in Tanzania. The World Health Organization (WHO) recommends regular efficacy monitoring of anti-malarial drugs to inform case management policy decisions. This study assessed the safety and efficacy of AL for treating uncomplicated P. falciparum malaria in Tanzania in 2022.
Methods: Children 6 months to 10 years with uncomplicated P. falciparum malaria were recruited from four sentinel sites and treated with the standard 6 dose, 3-day regimen for AL. Clinical and parasitological responses were monitored for 28 days using the WHO standard protocol. Genotyping based on msp1, msp2 and glurp was used to distinguish recrudescence from reinfection. SANGER sequencing was used to detect K13 mutations.
Results: 352 participants, 88 per site, were enrolled. Four withdrew and 55 experienced parasite recurrence. The PCR corrected Kaplan-Meier efficacies were, 89.9% in Pwani, 95.0% in Kigoma, 94.4% in Tanga, and 98.9% in Morogoro. No K13 mutations were found.
Conclusions: Artemether-lumefantrine remains highly efficacious in three regions of Tanzania but the PCR-corrected efficacy in Pwani fell below the WHO-defined 90% threshold at which policy change is recommended. Implementing strategies to diversify ACTs to ensure effective case management in Tanzania is critical.
(Published by Oxford University Press on behalf of Infectious Diseases Society of America 2024.)
Databáze: MEDLINE
načítá se...