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.
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
Known hypersensitivity or allergy to linezolid
Renal dysfunction (defined by age-appropriate serum creatinine and/or urine output)
Hepatic dysfunction (AST or ALT ≥3x age-specific upper limit of normal or clinically significant hepatic failure)
Gastrointestinal disorders expected to significantly impair drug absorption (e.g., short bowel syndrome, severe malabsorption)
Parallel
Linezolid (LZD)
DrugLinezolid 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.
Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24)
Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24) will be estimated using plasma linezolid concentrations collected after enteral administration of linezolid (either routine clinical dosing or a single study dose) and pharmacokinetic modeling. AUC0-24 will be reported in mcg hour per mL.
Apparent clearance of linezolid (CL/F)
Apparent clearance of linezolid following enteral administration (either routine clinical dosing or a single study dose) will be estimated from plasma linezolid concentrations using population pharmacokinetic modeling. Apparent clearance will be reported in L/hour.
Apparent volume of distribution of linezolid (V/F)
Apparent volume of distribution of linezolid following enteral administration (either routine clinical dosing or a single study dose) will be estimated from plasma linezolid concentrations using population pharmacokinetic modeling. Apparent volume of distribution will be reported in L per kilogram of body weight.
Absorption rate constant of linezolid (Ka)
The absorption rate constant of linezolid following enteral administration (either routine clinical dosing or a single study dose) will be estimated from plasma linezolid concentrations using population pharmacokinetic modeling. The absorption rate constant will be reported in 1/hour.
Concentrations of Linezolid and Primary Metabolites in Plasma
Measure plasma concentrations of linezolid and its primary metabolites at prespecified sampling time points following routine clinical dosing or a single study dose.
Percentage of participants achieving the prespecified linezolid pharmacodynamic target
Pharmacodynamic target attainment will be determined using model-estimated linezolid exposure and a prespecified pharmacodynamic target based on the AUC0-24/MIC ratio. The specific target threshold will be defined in the study analysis plan based on available pharmacodynamic data. The outcome will be reported as the percentage of participants achieving the prespecified target.
Percentage of Participants Experiencing One or More Adverse Events or Serious Adverse Events
Adverse events and serious adverse events will be assessed from signing the informed consent form through study completion, up to 5 days. The incidence, severity, and type of adverse events and serious adverse events will be assessed. The outcome will be reported as the percentage of participants experiencing one or more adverse events or serious adverse events.
Difference between PBPK model predicted and observed linezolid plasma concentrations
PBPK model predicted plasma linezolid concentrations will be compared with observed plasma linezolid concentrations collected at prespecified sampling time points. Predictive performance will be summarized using the ratio of predicted to observed concentrations.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
