Search > Linezolid
My employer runs this trial

Linezolid Pharmacokinetics for Infants

Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This study is for infants and young children who are already receiving linezolid as part of their medical care or can safely receive a single dose. Specific inclusion and exclusion criteria are not detailed, but participants must be able to provide blood samples.

Inclusion Criteria

I am taking antibiotics but have not been prescribed linezolid and can take one study dose.
Weight ≥2 kg
I am a baby who is 90 days old or younger and currently in the hospital.
See 3 more

Exclusion Criteria

Ongoing clinical instability that would make study participation unsafe as judged by treating team or principal investigator, including escalating vasoactive support or rapidly worsening organ dysfunction
Extracorporeal support or devices expected to substantially alter drug pharmacokinetics such as extracorporeal membrane oxygenation (ECMO)
Known hypersensitivity or allergy to linezolid
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • Linezolid

Trial Overview

Researchers are studying how the antibiotic linezolid moves through the bodies of young infants by measuring drug levels in blood after dosing. This will help improve future dosing recommendations for this age group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group 2: Single Study Dose of LinezolidExperimental Treatment1 Intervention
Group II: Group 1: Routine Clinical LinezolidActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.