دورية أكاديمية
أعرض في EDS

Therapeutic efficacy and tolerability of artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria in Niger, 2020.

التفاصيل البيبلوغرافية
العنوان: Therapeutic efficacy and tolerability of artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria in Niger, 2020.
المؤلفون: Laminou IM; Medical and Health Research Centre, Niamey, Niger. lamine.cermes@gmail.com., Issa I; Medical and Health Research Centre, Niamey, Niger., Adehossi E; Abdou Moumouni School of Health Sciences at University of Niamey-Niger , Niamey, Niger., Maman K; National Malaria Control Programme, Niamey, Niger., Jackou H; National Malaria Control Programme, Niamey, Niger., Coulibaly E; U.S. President's Malaria Initiative, USAID, Niamey, Niger., Tohon ZB; U.S. President's Malaria Initiative, USAID, Niamey, Niger., Ahmed J; U.S. President's Malaria Initiative Impact Malaria, Atlanta, USA., Sanoussi E; U.S. President's Malaria Initiative Impact Malaria, Niamey, Niger., Koko D; U.S. President's Malaria Initiative Impact Malaria, Niamey, Niger.
المصدر: Malaria journal [Malar J] 2024 May 13; Vol. 23 (1), pp. 144. Date of Electronic Publication: 2024 May 13.
نوع المنشور: Journal Article; Multicenter Study
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: Artemether, Lumefantrine Drug Combination*/therapeutic use , Malaria, Falciparum*/drug therapy , Antimalarials*/therapeutic use , Antimalarials*/adverse effects , Plasmodium falciparum*/drug effects , Plasmodium falciparum*/genetics, Child, Preschool ; Humans ; Niger ; Child ; Infant ; Adolescent ; Male ; Female ; Drug Resistance/genetics
مستخلص: Background: Monitoring therapeutic efficacy is important to ensure the efficacy of artemisinin-based combination therapy (ACT) for malaria. The current first-line treatment for uncomplicated malaria recommended by the National Malaria Control Program in Niger is artemether-lumefantrine (AL). In 2020, an in vivo study was carried out to evaluate clinical and parasitological responses to AL as well as the molecular resistance to the drug in three sentinel sites: Agadez, Tessaoua and Gaya, in Niger.
Methods: A multi-center, single-arm trial was conducted according to the 28-day World Health Organization (WHO) 2009 therapeutic efficacy study protocol. Children between 6 months and 15 years with confirmed uncomplicated Plasmodium falciparum infection and 1000-200,000 asexual parasites/μL of blood were enrolled and followed up for 28 days. Uncorrected and PCR-corrected efficacy results at day 28 were calculated, and molecular correction was performed by genotyping the msp1, msp2, and glurp genes. The pfk13, pfdhfr, pfdhps, pfcrt and pfmdr genes were analyzed by PCR and Sanger sequencing. The Kaplan-Meier curve assessed parasite clearance.
Results: A total of 255 patients were enrolled in the study. The adequate clinical and parasitological response after PCR correction was 98.9% (95% CI 96.4-101.0%), 92.2% (85.0-98.5%) and 97.1% (93.1-101.0%) in Gaya, Tessaoua and Agadez, respectively. No adverse events were observed. Ten mutations (SNP) were found, including 7 synonyms (K248K, G690G, E691E, E612E, C469C, G496G, P718P) and 3 non-synonyms (N594K, R255K, V714S). Two mutations emerged: N594K and V714S. The R255K mutation detected in Southeast Asia was also detected. The pfdhpsK540E and pfdhfrI164L mutations associated with high levels of resistance are absent. There is a reversal of chloroquine resistance.
Conclusion: The study findings indicate that AL is effective and well tolerated for the treatment of uncomplicated malaria in three sites in Niger. The emergence of a pfk13 mutation requires additional testing such as the Ring Stage Assay and CRISPR/Cas9 to confirm the role of these emerging mutations. Trial registration NCT05070520, October 7, 2021.
(© 2024. The Author(s).)
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فهرسة مساهمة: Keywords: P. falciparum; Artemether–lumefantrine; Efficacy; Niger; Resistance
سلسلة جزيئية: ClinicalTrials.gov NCT05070520
المشرفين على المادة: 0 (Artemether, Lumefantrine Drug Combination)
0 (Antimalarials)
تواريخ الأحداث: Date Created: 20240513 Date Completed: 20240514 Latest Revision: 20240516
رمز التحديث: 20240516
مُعرف محوري في PubMed: PMC11092133
DOI: 10.1186/s12936-024-04945-8
PMID: 38741101
قاعدة البيانات: MEDLINE
الوصف
تدمد:1475-2875
DOI:10.1186/s12936-024-04945-8