Dalbavancin Pharmacokinetics and Safety in Children 3 Months to 11 Years of Age.

Published

Journal Article

BACKGROUND: Dalbavancin is a novel lipoglycopeptide antibiotic that has potent in vitro activity against Gram-positive microorganisms. METHODS: We performed a phase 1, open-label, multicenter study to investigate the pharmacokinetics (PK) and safety of a single dose of intravenous dalbavancin in hospitalized pediatric subjects 3 months to 11 years of age. We combined these data with previously collected adolescent PK data and performed a population PK analysis. RESULTS: Model development was performed using 311 dalbavancin plasma concentrations from 43 subjects. The median age was 5.9 years (range: 0.3-16.9). A 3-compartment, linear PK model was developed. Based on simulations, the following age-dependent dosing regimen was found to achieve similar dalbavancin exposure to that in adults administered a 2-dose regimen: children 6 to <18 years of age, 12 mg/kg (1000 mg maximum) on day 1 and 6 mg/kg (500 mg maximum) on day 8 and children 3 months to <6 years of age, 15 mg/kg (1000 mg maximum) on day 1 and 7.5 mg/kg (500 mg maximum) on day 8. Similarly, the following age-dependent regimen was found to match adult exposure after a single-dose (1500 mg): 6 to <18 years of age, 18 mg/kg (1500 mg maximum) on day 1 and 3 months to <6 years of age, 22.5 mg/kg (1500 mg maximum) on day 1. Nineteen subjects experienced 36 treatment-emergent adverse events. Five of 36 adverse events were assessed as possibly or probably related to treatment. CONCLUSIONS: Dalbavancin pediatric dosing that matched adult exposure was identified. Overall, dalbavancin was well tolerated in our study population.

Full Text

Duke Authors

Cited Authors

  • Gonzalez, D; Bradley, JS; Blumer, J; Yogev, R; Watt, KM; James, LP; Palazzi, DL; Bhatt-Mehta, V; Sullivan, JE; Zhang, L; Murphy, J; Ussery, XT; Puttagunta, S; Dunne, MW; Cohen-Wolkowiez, M

Published Date

  • July 2017

Published In

Volume / Issue

  • 36 / 7

Start / End Page

  • 645 - 653

PubMed ID

  • 28060045

Pubmed Central ID

  • 28060045

Electronic International Standard Serial Number (EISSN)

  • 1532-0987

Digital Object Identifier (DOI)

  • 10.1097/INF.0000000000001538

Language

  • eng

Conference Location

  • United States