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

ABSTRACT:

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 t

SUBMITTER: Gonzalez D 

PROVIDER: S-EPMC5468484 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature