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

التفاصيل البيبلوغرافية
العنوان: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in mainland Tanzania, 2019.
المؤلفون: Ngasala BE; Department of Parasitology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. bngasala70@gmail.com., Chiduo MG; National Institute for Medical Research, Tanga Research Centre, Tanga, Tanzania., Mmbando BP; National Institute for Medical Research, Tanga Research Centre, Tanga, Tanzania., Francis FT; National Institute for Medical Research, Tanga Research Centre, Tanga, Tanzania., Bushukatale S; Department of Parasitology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania., Makene T; Department of Parasitology, School of Public Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania., Mandara CI; National Institute for Medical Research, Headquarters, Dar es Salaam, Tanzania., Ishengoma DS; National Institute for Medical Research, Headquarters, Dar es Salaam, Tanzania., Kamugisha E; Catholic University of Health and Allied Sciences, Bugando Medical Centre, Mwanza, Tanzania., Ahmed M; Catholic University of Health and Allied Sciences, Bugando Medical Centre, Mwanza, Tanzania., Mahende MK; Ifakara Health Institute, Dar-es-Salaam, Tanzania., Kavishe RA; Kilimanjaro Christian Medical Centre, Kilimanjaro Christian Medical University College, Moshi, Tanzania., Muro F; Kilimanjaro Christian Medical Centre, Kilimanjaro Christian Medical University College, Moshi, Tanzania., Molteni F; National Malaria Control Program, Dodoma, Tanzania., Reaves E; U.S. President's Malaria Initiative, U.S. Centers for Disease Control and Prevention, Dar es Salaam, Tanzania., Kitojo C; U.S. President's Malaria Initiative, U.S. Agency for International Development, Dar es Salaam, Tanzania., Greer G; U.S. President's Malaria Initiative, U.S. Agency for International Development, Dar es Salaam, Tanzania., Nyinondi S; R.T.I. International, Dar es Salaam, Tanzania., Kabula B; R.T.I. International, Dar es Salaam, Tanzania., Lalji S; R.T.I. International, Dar es Salaam, Tanzania., Chacky F; National Malaria Control Program, Dodoma, Tanzania., Njau RJ; Muhimbili University of Health and Allied Science, Dar es Salaam, Tanzania., Warsame M; Gothenburg University, Gothenburg, Sweden., Mohamed A; National Malaria Control Program, Dodoma, Tanzania.
المصدر: Malaria journal [Malar J] 2024 Apr 09; Vol. 23 (1), pp. 101. Date of Electronic Publication: 2024 Apr 09.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101139802 Publication Model: Electronic Cited Medium: Internet ISSN: 1475-2875 (Electronic) Linking ISSN: 14752875 NLM ISO Abbreviation: Malar J Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2002-
مواضيع طبية MeSH: Antimalarials*/adverse effects , Malaria, Falciparum*/drug therapy , Artemisinins*/adverse effects , Malaria*/drug therapy, Child ; Humans ; Infant ; Artemether, Lumefantrine Drug Combination/adverse effects ; Tanzania ; Reinfection/chemically induced ; Reinfection/drug therapy ; Prospective Studies ; Drug Combinations ; Artemether/therapeutic use ; Amodiaquine/therapeutic use ; Treatment Outcome ; Plasmodium falciparum
مستخلص: 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 serious adverse event was reported.
Conclusion: This study showed that AL had adequate efficacy and safety for the treatment of uncomplicated falciparum malaria in Tanzania in 2019. The high recurrent infections were mainly due to new infections, highlighting the potential role of introducing alternative artemisinin-based combinations that offer improved post-treatment prophylaxis, such as artesunate-amodiaquine (ASAQ).
(© 2024. The Author(s).)
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فهرسة مساهمة: Keywords: Plasmodium falciparum; Artemether-Lumefantrine; Malaria; Therapeutic efficacy
المشرفين على المادة: 0 (Antimalarials)
0 (Artemether, Lumefantrine Drug Combination)
0 (Drug Combinations)
C7D6T3H22J (Artemether)
9RMU91N5K2 (artemisinin)
0 (Artemisinins)
220236ED28 (Amodiaquine)
تواريخ الأحداث: Date Created: 20240409 Date Completed: 20240411 Latest Revision: 20240425
رمز التحديث: 20240425
مُعرف محوري في PubMed: PMC11005286
DOI: 10.1186/s12936-024-04931-0
PMID: 38594679
قاعدة البيانات: MEDLINE
الوصف
تدمد:1475-2875
DOI:10.1186/s12936-024-04931-0