Document Type

Article

Publication Date

11-15-2023

Identifier

DOI: 10.1128/aac.00987-23; PMCID: PMC10649008

Abstract

Antimicrobial resistance increases infection morbidity in both adults and children, necessitating the development of new therapeutic options. Telavancin, an antibiotic approved in the United States for certain bacterial infections in adults, has not been examined in pediatric patients. The objectives of this study were to evaluate the short-term safety and pharmacokinetics (PK) of a single intravenous infusion of telavancin in pediatric patients. Single-dose safety and PK of 10 mg/kg telavancin was investigated in pediatric subjects >12 months to ≤17 years of age with known or suspected bacterial infection. Plasma was collected up to 24-h post-infusion and analyzed for concentrations of telavancin and its metabolite for noncompartmental PK analysis. Safety was monitored by physical exams, vital signs, laboratory values, and adverse events following telavancin administration. Twenty-two subjects were enrolled: 14 subjects in Cohort 1 (12-17 years), 7 subjects in Cohort 2 (6-11 years), and 1 subject in Cohort 3 (2-5 years). A single dose of telavancin was well-tolerated in all pediatric age cohorts without clinically significant effects. All age groups exhibited increased clearance of telavancin and reduced exposure to telavancin compared to adults, with mean peak plasma concentrations of 58.3 µg/mL (Cohort 1), 60.1 µg/mL (Cohort 2), and 53.1 µg/mL (Cohort 3). A 10 mg/kg dose of telavancin was well tolerated in pediatric subjects. Telavancin exposure was lower in pediatric subjects compared to adult subjects. Further studies are needed to determine the dose required in phase 3 clinical trials in pediatrics.

Journal Title

Antimicrobial agents and chemotherapy

Volume

67

Issue

11

First Page

0098723

Last Page

0098723

MeSH Keywords

Adult; Humans; Child; Aminoglycosides; Anti-Bacterial Agents; Lipoglycopeptides; Infusions, Intravenous

Keywords

antimicrobial agents; clinical therapeutics; pediatric drug therapy; pharmacokinetics

Comments

Grants and funding

This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

Publisher's Link: https://doi.org/10.1128/aac.00987-23

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