Pharmacokinetics and safety of a single dose of telavancin in pediatric subjects 2-17 years of age.

Autor:	Bradley JS; Department of Pediatrics, University of California San Diego School of Medicine and Rady Children's Hospital , San Diego, California, USA., Goldman JL; Department of Pediatrics, University of Missouri-Kansas City and Children's Mercy Hospital , Kansas City, Missouri, USA., James LP; Department of Pediatrics, Arkansas Children's Hospital Research Institute , Little Rock, Arkansas, USA., Kaelin B; Product Development, Cumberland Pharmaceuticals Inc. , Nashville, Tennessee, USA., Gibson BHY; Product Development, Cumberland Pharmaceuticals Inc. , Nashville, Tennessee, USA., Arrieta A; Division of Infectious Diseases, Children's Hospital of Orange County , Orange County, California, USA.
Jazyk:	angličtina
Zdroj:	Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2023 Nov 15; Vol. 67 (11), pp. e0098723. Date of Electronic Publication: 2023 Oct 10.
DOI:	10.1128/aac.00987-23
Abstrakt:	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. Competing Interests: J.S.B., J.L.G., L.P.J., and A.A. were investigators on this clinical study. B.K. and B.H.Y.G. are employees of Cumberland Pharmaceuticals.
Databáze:	MEDLINE
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