Objective
To evaluate the dosing, efficacy and safety of the main antileishmanial agents amphotericin B (conventional or liposomal), pentavalent antimonials, miltefosine and paromomycin recommended for the treatment of visceral leishmaniasis in children.
Methods
The efficacy and safety of visceral leishmaniasis treatments in children were systematically reviewed using literature from PubMed, Cochrane, clinicaltrials.gov, and Google Scholar, focusing on randomised trials with separate pediatric data (published from 2000-2024). The risk of bias of selected trials was assessed using the revised Cochrane risk-of-bias tool for randomised trials (RoB 2). Reporting was done per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist.
Results
Of 1 186 records, only 7 were eligible for qualitative synthesis. Three trials exclusively included children. The treatment regimens studied showed high heterogeneity and lacked sufficient data for a meta-analysis. Most trial arms reported efficacies over 94% for children across different regimens. Miltefosine monotherapy showed the highest rate of late treatment failures, highlighting that allometric dosing is crucial to ensure proper drug exposure in children. Safety data for children were available in only three studies with varied reporting systems of adverse events. Although regimens in this review were generally considered to be safe in children, antimonial-related cardiac toxicity remains a threat.
Conclusions
This review highlights the need for pediatric-specific trials, clear presentation of pediatric data, and systematic documentation of adverse events to enhance evidence for policy-making and pediatric guideline development.
BT - Asian Pacific Journal of Tropical Medicine DO - 10.4103/apjtm.apjtm_685_24 IS - 6 LA - ENG M3 - Article N2 -Objective
To evaluate the dosing, efficacy and safety of the main antileishmanial agents amphotericin B (conventional or liposomal), pentavalent antimonials, miltefosine and paromomycin recommended for the treatment of visceral leishmaniasis in children.
Methods
The efficacy and safety of visceral leishmaniasis treatments in children were systematically reviewed using literature from PubMed, Cochrane, clinicaltrials.gov, and Google Scholar, focusing on randomised trials with separate pediatric data (published from 2000-2024). The risk of bias of selected trials was assessed using the revised Cochrane risk-of-bias tool for randomised trials (RoB 2). Reporting was done per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist.
Results
Of 1 186 records, only 7 were eligible for qualitative synthesis. Three trials exclusively included children. The treatment regimens studied showed high heterogeneity and lacked sufficient data for a meta-analysis. Most trial arms reported efficacies over 94% for children across different regimens. Miltefosine monotherapy showed the highest rate of late treatment failures, highlighting that allometric dosing is crucial to ensure proper drug exposure in children. Safety data for children were available in only three studies with varied reporting systems of adverse events. Although regimens in this review were generally considered to be safe in children, antimonial-related cardiac toxicity remains a threat.
Conclusions
This review highlights the need for pediatric-specific trials, clear presentation of pediatric data, and systematic documentation of adverse events to enhance evidence for policy-making and pediatric guideline development.
PB - Ovid Technologies (Wolters Kluwer Health) PY - 2025 SP - 243 EP - 252 T2 - Asian Pacific Journal of Tropical Medicine TI - Therapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review UR - https://journals.lww.com/aptm/_layouts/15/oaks.journals/downloadpdf.aspx?trckng_src_pg=ArticleViewer&an=01542552-202506000-00002 VL - 18 SN - 1995-7645, 2352-4146 ER -