Oral Antibiotic Pharmacokinetics in Young Infants

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07815613
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Infant and Young Children
  • Linezolid
  • Linezolid Pharmacokinetics in Young Infants
  • Pharmacokinetic Analysis

Eligibility Criteria

Sex
ALL
Age
0 Days - 90 Days
Healthy Volunteers
Not accepted

Interventions

  • Linezolid (LZD) — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 11, 2026
Start date
Jan 1, 2027
Status verified
Sep 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Group 1: Routine Clinical Linezolid
    Participants receiving linezolid as part of routine clinical care will undergo pharmacokinetic blood sampling and clinical data collection.
  • Experimental: Group 2: Single Study Dose of Linezolid
    Participants will receive a single study-administered dose of linezolid (10 mg/kg/dose enterally) followed by pharmacokinetic blood sampling and clinical data collection.

Primary Outcome Measure

Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24) [ Time Frame: From 0 to 24 hours after administration of an enteral linezolid dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado, DenverAuroraColorado80045
Andrew S Haynes, MD
[email protected]
720-777-6783
Andrew S Haynes, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado, Denver· Aurora, CO