Oral Antibiotic Pharmacokinetics in Young Infants
8 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado, Denver
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Contato:
- Andrew S Haynes, MD
- Número de telefone: 720-777-6783
- E-mail: andrew.haynes@childrenscolorado.org
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Investigador principal:
- Andrew S Haynes, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Area under the plasma linezolid concentration versus time curve from 0 to 24 hours (AUC0-24)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Concentrations of Linezolid and Primary Metabolites in Plasma
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference between PBPK model predicted and observed linezolid plasma concentrations
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de janeiro de 2027
Conclusão Primária (Estimado)
31 de dezembro de 2029
Conclusão do estudo (Estimado)
31 de dezembro de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
6 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de setembro de 2026
Primeira postagem (Real)
11 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-1733
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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