02719nas a2200265   4500000000100000008004100001260004600042653002700088653001300115653001400128653001300142653001100155653002200166100001600188700002000204700001800224700001900242700001700261245012200278856013300400300001200533490000700545520187600552022002502428       2025                            d  bOvid Technologies (Wolters Kluwer Health)10avisceral leishmaniosis10aChildren10aTreatment10aEfficacy10aSafety10aSystematic review1 aDe Silva NL1 aHettiarachchi M1 aRanasinghe CS1 aYahathugoda TC1 aRanasinghe S00aTherapeutic efficacy and safety of antileishmanial agents for visceral leishmaniasis in children: A systematic review  uhttps://journals.lww.com/aptm/_layouts/15/oaks.journals/downloadpdf.aspx?trckng_src_pg=ArticleViewer&an=01542552-202506000-00002  a243-2520 v183 a<p><strong>Objective</strong></p>

<p>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.</p>

<p><strong>Methods</strong></p>

<p>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.</p>

<p><strong>Results</strong></p>

<p>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.</p>

<p><strong>Conclusions</strong></p>

<p>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.</p>
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