Tiny patients, big dosing questions: scientists map how babies process a key antibiotic
NCT ID NCT07815613
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are studying how the antibiotic linezolid moves through the bodies of newborns and young infants. Up to 40 hospitalized infants will either receive linezolid as part of their routine care or a single study dose. Blood samples will measure drug levels over time, and researchers will use that data to build models that could guide more precise dosing for this vulnerable group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- linezolid, an oral antibiotic
- What this could lead to
- If the models work, doctors could dose linezolid more precisely in newborns, which may improve treatment and reduce the risk of under- or over-dosing.
- What could go wrong
- This is a small pharmacokinetic study of 40 infants, so the models may not capture all the variation in how sick newborns handle the drug. Blood sampling in infants carries some burden, and the findings may not apply to older children or adults.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 90 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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) * Severe anemia or other condition that precludes study-required blood sampling * Extracorporeal support or other devices expected to substantially alter drug pharmacokinetics (e.g., extracorporeal membrane oxygenation \[ECMO\]). * Therapeutic hypothermia * Ongoing clinical instability that, in the opinion of the treating team or principal investigator (PI), would make study participation unsafe (e.g., escalating vasoactive support or rapidly worsening organ dysfunction).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado, Denver
Aurora, Colorado, 80045, United States
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