University of Colorado, Denver
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.
Young infants are at increased risk for serious bacterial infections, yet limited pharmacokinetic data are available to guide evidence-based dosing of oral linezolid in this population. Developmental changes in drug absorption, distribution, metabolism, and elimination during early infancy contribute to variability in drug exposure, making it difficult to optimize dosing using existing recommendations. This prospective pharmacokinetic study will enroll young infants who receive linezolid either as part of routine clinical care or as a single, one-time study dose. Blood samples will be collect…
Inclusion Criteria: * Hospitalized neonate or young infant ≤90 days postnatal age at screening * Weight ≥2 kg * Receiving systemic antibiotic therapy * Tolerating enteral medication(s) and/or enteral feeds * Group 1: Receiving oral linezolid as part of routine clinical care. * Group 2: Receiving systemic antibiotic therapy but not prescribed linezolid clinically and eligible to receive a single oral study dose. Exclusion Criteria: * Known hypersensitivity or allergy to linezolid * Renal dysfunction (defined by age-appropriate serum creatinine and/or urine output) * Hepatic dysfunction (AST…
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.
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