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NOT YET RECRUITING
NCT07815613
PHASE4

Oral Antibiotic Pharmacokinetics in Young Infants

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This observational study will characterize the pharmacokinetics of linezolid in young infants. Participants will receive linezolid either as part of routine clinical care or as a single, one-time study dose. Blood samples collected following linezolid administration will be used to measure drug concentrations and describe how linezolid is absorbed, distributed, metabolized, and eliminated in this population. Clinical information, including demographic characteristics, laboratory values, and treatment details, will also be collected. The results will be used to develop pharmacokinetic models to improve linezolid dosing recommendations and support precision dosing in young infants.

Official title: Characterizing Absorption Kinetics of Oral Antibiotics in Young Infants to Enhance Precision Dosing

Key Details

Gender

All

Age Range

0 Days - 90 Days

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2027-01-01

Completion Date

2030-12-31

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

Linezolid (LZD)

Linezolid is administered either as part of routine clinical care or as a single, one-time study dose (10 mg/kg/dose enterally), depending on study arm. Participants undergo pharmacokinetic blood sampling after linezolid administration to characterize drug disposition in young infants.

Locations (1)

University of Colorado, Denver

Aurora, Colorado, United States