Oral Antibiotic Pharmacokinetics in Young Infants
8 september 2026 bijgewerkt door: University of Colorado, Denver
Characterizing Absorption Kinetics of Oral Antibiotics in Young Infants to Enhance Precision Dosing
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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 collected to measure plasma linezolid concentrations, and demographic, clinical, laboratory, and medication data will be collected from the medical record. These data will be used to develop pharmacokinetic models and evaluate sources of variability in linezolid exposure, including developmental and clinical factors.
The results of this study are expected to improve the understanding of oral linezolid pharmacokinetics in young infants and support the development of model-informed dosing strategies to optimize antibiotic exposure, maximize treatment effectiveness, and minimize toxicity in this vulnerable population.
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado, Denver
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Contact:
- Andrew S Haynes, MD
- Telefoonnummer: 720-777-6783
- E-mail: andrew.haynes@childrenscolorado.org
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Hoofdonderzoeker:
- Andrew S Haynes, MD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Group 1: Routine Clinical Linezolid
Participants receiving linezolid as part of routine clinical care will undergo pharmacokinetic blood sampling and clinical data collection.
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Experimenteel: 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.
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24)
Tijdsspanne: From 0 to 24 hours after administration of an enteral linezolid dose
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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.
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From 0 to 24 hours after administration of an enteral linezolid dose
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Apparent clearance of linezolid (CL/F)
Tijdsspanne: From 0 to 12 hours after administration an enteral linezolid dose
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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.
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From 0 to 12 hours after administration an enteral linezolid dose
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Apparent volume of distribution of linezolid (V/F)
Tijdsspanne: From 0 to 12 hours after administration of an enteral linezolid dose
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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.
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From 0 to 12 hours after administration of an enteral linezolid dose
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Absorption rate constant of linezolid (Ka)
Tijdsspanne: From 0 to 12 hours after administration of an enteral linezolid dose
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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.
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From 0 to 12 hours after administration of an enteral linezolid dose
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Concentrations of Linezolid and Primary Metabolites in Plasma
Tijdsspanne: From 0 to 12 hours after administration of an enteral linezolid dose
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Measure plasma concentrations of linezolid and its primary metabolites at prespecified sampling time points following routine clinical dosing or a single study dose.
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From 0 to 12 hours after administration of an enteral linezolid dose
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Percentage of participants achieving the prespecified linezolid pharmacodynamic target
Tijdsspanne: From 0 to 12 hours after administration of an enteral linezolid dose
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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.
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From 0 to 12 hours after administration of an enteral linezolid dose
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Percentage of Participants Experiencing One or More Adverse Events or Serious Adverse Events
Tijdsspanne: From signing the informed consent form through study completion, up to 5 days
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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.
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From signing the informed consent form through study completion, up to 5 days
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Difference between PBPK model predicted and observed linezolid plasma concentrations
Tijdsspanne: From 0 to 12 hours after administration of an enteral linezolid dose
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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.
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From 0 to 12 hours after administration of an enteral linezolid dose
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 januari 2027
Primaire voltooiing (Geschat)
31 december 2029
Studie voltooiing (Geschat)
31 december 2030
Studieregistratiedata
Eerst ingediend
6 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 september 2026
Eerst geplaatst (Werkelijk)
11 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 september 2026
Laatste update ingediend die voldeed aan QC-criteria
8 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 26-1733
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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