Related Experiment Video
Updated: Mar 9, 2026
A Reference Broth Microdilution Method for Dalbavancin In Vitro Susceptibility Testing of Bacteria that Grow Aerobically
Published on: September 9, 2015
Dalbavancin Pharmacokinetics and Safety in Children 3 Months to 11 Years of Age
Daniel Gonzalez1, John S Bradley, Jeffrey Blumer
1From the*Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; †University of California San Diego School of Medicine and Rady Children's Hospital, San Diego, California; ‡University of Toledo Medical Center, Toledo, Ohio; §Ann & Robert H. Lurie Children's Hospital of Chicago, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; ¶Department of Pediatrics, Duke University Medical Center, and ‖Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; **Arkansas Children's Hospital Research Institute and University of Arkansas for Medical Sciences, Little Rock, Arkansas; ††Infectious Diseases Section, Baylor College of Medicine, Houston, Texas; ‡‡College of Pharmacy and Department of Pediatrics, University of Michigan, Ann Arbor, Michigan; §§Kosair Charities Pediatric Clinical Research Unit, Department of Pediatrics, University of Louisville, and ¶¶Kosair Children's Hospital, Louisville, Kentucky; ‖‖Institute for Clinical Pharmacodynamics, Latham, New York; and ***Durata Therapeutics, a subsidiary of Actavis plc, Branford, Connecticut.
Insights
New dosing regimens for dalbavancin (a lipoglycopeptide antibiotic) in pediatric patients were identified to match adult exposure levels. Dalbavancin demonstrated good tolerability in children aged 3 months to 11 years.
Area of Science:
- Pharmacology
- Infectious Diseases
- Pediatrics
Background:
- Dalbavancin is a novel lipoglycopeptide antibiotic with potent in vitro activity against Gram-positive bacteria.
- Effective antibiotic treatment in pediatric populations requires careful consideration of pharmacokinetic properties.
Purpose of the Study:
- To investigate the pharmacokinetics (PK) and safety of intravenous dalbavancin in hospitalized pediatric subjects.
- To establish age-dependent dosing regimens for dalbavancin in children to achieve exposures comparable to adults.
Main Methods:
- A phase 1, open-label, multicenter study was conducted in pediatric subjects aged 3 months to 11 years.
- Population PK analysis was performed using 311 dalbavancin plasma concentrations from 43 subjects, combined with adolescent PK data.
- Age-dependent dosing regimens were simulated to match adult dalbavancin exposure.
Main Results:
- A 3-compartment, linear PK model was developed.
- Age-dependent dosing regimens were proposed to achieve similar dalbavancin exposure to adults: (1) 12 mg/kg (day 1) and 6 mg/kg (day 8) for ages 6 to <18 years, and (2) 15 mg/kg (day 1) and 7.5 mg/kg (day 8) for ages 3 months to <6 years.
- Alternatively, single-dose regimens of 18 mg/kg (ages 6 to <18 years) and 22.5 mg/kg (ages 3 months to <6 years) were identified to match adult single-dose exposure.
- 36 treatment-emergent adverse events were reported in 19 subjects, with 5 assessed as possibly or probably related to dalbavancin.
Conclusions:
- Pediatric dosing regimens for dalbavancin were identified that successfully match adult exposure levels.
- Dalbavancin was found to be well tolerated in the studied pediatric population.
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.
More Related Videos
09:17A Robust Pneumonia Model in Immunocompetent Rodents to Evaluate Antibacterial Efficacy against S. pneumoniae, H. influenzae, K. pneumoniae, P. aeruginosa or A. baumannii
Published on: January 2, 2017
06:36Establishing the Minimal Bactericidal Concentration of an Antimicrobial Agent for Planktonic Cells MBC-P and Biofilm Cells MBC-B
Published on: January 2, 2014
Related Concept Videos
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
01:29Drug Dosing: Infants and Children
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
01:17Pharmacokinetics in Pediatric Patients: Drug Distribution
01:15Determination of Multiple Dosing Parameters: Steady-State, Minimum and Maximum Concentrations