Oral Antibiotic Pharmacokinetics in Young Infants
8 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado, Denver
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Contacto:
- Andrew S Haynes, MD
- Número de teléfono: 720-777-6783
- Correo electrónico: andrew.haynes@childrenscolorado.org
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Investigador principal:
- Andrew S Haynes, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concentrations of Linezolid and Primary Metabolites in Plasma
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference between PBPK model predicted and observed linezolid plasma concentrations
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
6 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Publicado por primera vez (Actual)
11 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-1733
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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