Oral Antibiotic Pharmacokinetics in Young Infants
8 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80045
- University of Colorado, Denver
-
Contact:
- Andrew S Haynes, MD
- Numéro de téléphone: 720-777-6783
- E-mail: andrew.haynes@childrenscolorado.org
-
Chercheur principal:
- Andrew S Haynes, MD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Group 1: Routine Clinical Linezolid
Participants receiving linezolid as part of routine clinical care will undergo pharmacokinetic blood sampling and clinical data collection.
|
|
|
Expérimental: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24)
Délai: From 0 to 24 hours after administration of an enteral linezolid dose
|
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.
|
From 0 to 24 hours after administration of an enteral linezolid dose
|
|
Apparent clearance of linezolid (CL/F)
Délai: From 0 to 12 hours after administration an enteral linezolid dose
|
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.
|
From 0 to 12 hours after administration an enteral linezolid dose
|
|
Apparent volume of distribution of linezolid (V/F)
Délai: From 0 to 12 hours after administration of an enteral linezolid dose
|
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.
|
From 0 to 12 hours after administration of an enteral linezolid dose
|
|
Absorption rate constant of linezolid (Ka)
Délai: From 0 to 12 hours after administration of an enteral linezolid dose
|
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.
|
From 0 to 12 hours after administration of an enteral linezolid dose
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Concentrations of Linezolid and Primary Metabolites in Plasma
Délai: From 0 to 12 hours after administration of an enteral linezolid dose
|
Measure plasma concentrations of linezolid and its primary metabolites at prespecified sampling time points following routine clinical dosing or a single study dose.
|
From 0 to 12 hours after administration of an enteral linezolid dose
|
|
Percentage of participants achieving the prespecified linezolid pharmacodynamic target
Délai: From 0 to 12 hours after administration of an enteral linezolid dose
|
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.
|
From 0 to 12 hours after administration of an enteral linezolid dose
|
|
Percentage of Participants Experiencing One or More Adverse Events or Serious Adverse Events
Délai: From signing the informed consent form through study completion, up to 5 days
|
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.
|
From signing the informed consent form through study completion, up to 5 days
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference between PBPK model predicted and observed linezolid plasma concentrations
Délai: From 0 to 12 hours after administration of an enteral linezolid dose
|
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.
|
From 0 to 12 hours after administration of an enteral linezolid dose
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 janvier 2027
Achèvement primaire (Estimé)
31 décembre 2029
Achèvement de l'étude (Estimé)
31 décembre 2030
Dates d'inscription aux études
Première soumission
6 août 2026
Première soumission répondant aux critères de contrôle qualité
8 septembre 2026
Première publication (Réel)
11 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26-1733
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .