Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis

31 de agosto de 2021 actualizado por: National Jewish Health
Cystic fibrosis (CF) is the most common inherited disease in the western world. On a yearly basis, 56% of CF patients, or nearly 17,000 individuals in the US, suffer from acute pulmonary exacerbations (APE). The purpose of this study is to test a candidate assay for its ability to diagnose APE, the most important disease event in CF. While previous studies have been able to identify biomarkers of CF prognosis and risk stratification, three markers have demonstrated characteristics ideal for APE diagnosis: CD64, TLR2, and GILT. CD64 is a cellular receptor, expressed on numerous cells of the immune system, whose role is to bind antibodies which are attached to infected cells or pathogens. TLR2 plays a major role in early host-microbial interactions. GILT has been shown to be more precise in targeting immune responses against antigens and influences T lymphocyte response. This study looks to identify the differences in the expression of neutrophil CD64 and CD4+ T cell TLR2 and GILT between acute illness and baseline health as a sensitive marker of acute pulmonary exacerbation so that it may facilitate rapid hematologic diagnosis of the condition. The study also looks to compare sensitivity and specificity of the assays above to standard measures, such as health related quality of life scores (CFQ-R), loss of lung function, white blood cell counts and CRP, for diagnosing acute exacerbations.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

150

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

  • Estados Unidos
    • Colorado
      • Denver, Colorado, Estados Unidos, 80206
        • National Jewish Health

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

CF patients aged 18 years or older at the time of an acute pulmonary exacerbation or at baseline health who are followed by the Adult CF Program at National Jewish Health will be eligible to enroll in this study.

Descripción

Inclusion Criteria:

  • Documented diagnosis of CF.
  • Age 18 years old or greater.
  • Presentation at baseline health OR at the start of treatment for a pulmonary exacerbation of CF.
  • Ability to perform reproducible Pulmonary Function Tests
  • Ability to produce sputum.
  • Willingness to complete a health-related quality of life questionnaire
  • Willingness to comply with study procedure and provide written consent.

Exclusion Criteria:

• Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.

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

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Acute Pulmonary Exacerbation (APE)
Those subjects presenting with APE will be treated with at least two pathogen specific I.V. antibiotics, as dictated by their treating physician and compliant with standard guidelines for care of an APE.
Baseline Health
Those subjects presenting at baseline health will be identified by their treating physician as such and will not be starting on any treatments for APE.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in neutrophil CD64 expression
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
The primary outcome measure is the difference in expression of neutrophil CD64 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Difference in CD4+ T cell TLR2 expression
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
The primary outcome measure is the difference in expression of CD4+ T cell TLR2 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Difference in GILT expression
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
The primary outcome measure is the difference in expression of GILT as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation of primary outcome measurements with lung function tests
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with changes in FEV1 as measured by spirometry.
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Correlation of primary outcome measurements with C-Reactive Protein
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in C-Reactive Protein (CRP)
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Correlation of primary outcome measurements with total white blood cell counts
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in total white blood cell counts (WBC).
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Correlation of primary outcome measurements with sputum inflammatory markers
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in sputum inflammatory markers as measured by sputum neutrophil counts and neutrophil elastase expression.
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Correlation of primary outcome measurements with phagocytosis
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in the percentage of phagocytosis by isolated neutrophils.
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Correlation of primary outcome measurements with quality of life questionnaire score
Periodo de tiempo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in patient reported health related quality of life scores as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R).
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Jewish Health

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 (Actual)

10 de septiembre de 2014

Finalización primaria (Actual)

23 de mayo de 2019

Finalización del estudio (Actual)

31 de agosto de 2021

Fechas de registro del estudio

Enviado por primera vez

18 de mayo de 2020

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2020

Publicado por primera vez (Actual)

21 de mayo de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de septiembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

31 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 14BGF-10

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Fibrosis quística

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Singapore

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

Suscribir