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Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis

23 de mayo de 2017 actualizado por: Weill Medical College of Cornell University
Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization towards a distinct phenotype associated with impaired host defense function against Mtb and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophage (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.

Descripción general del estudio

Estado

Retirado

Condiciones

Descripción detallada

Samples from Non-Smokers with TB, Smokers with TB and Smokers with COPD and TB will be collected in Qatar under JIRB 14-00055. All subjects will be undergoing a clinical bronchoscopy as part of their disease evaluation and will be asked to give additional samples for research. All "in vivo" processing of specimens from subjects with TB will be performed in Qatar. Mycobacterium tuberculosis infection (Mtb) continues to have a detrimental impact of public health worldwide. Based on the epidemiological evidence linking smoking, COPD and Mtb, and our preliminary data we hypothesize that smoking reprograms Alveolar Macrophages (AM) polarization towards a distinct phenotype associated with impaired host defense function against Myobacterium tuberculosis (Mtb) and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophages (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.

Tipo de estudio

De observación

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

  • Katar
      • Doha, Katar
        • Hamad Medical Corporation

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 a 60 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Recruitment will be from the referral base of the responsible investigator and other physicians, and review of admissions and hospital database. Patients, who may qualify for this study, will be identified by chart review, physician referral, and recruited by study investigators. The source of potential subjects will be the population of potential subjects with TB (smokers or non smokers), and with both TB and COPD, as defined before. Accrual will be random with no bias as to gender or racial/ethnic group.

Descripción

Smokers and Non-smokers with TB

Inclusion Criteria:

  • Must provide informed consent
  • Current smokers and non-smokers
  • Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease
  • Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:
  • Symptoms consistent with TB
  • Chest xray and or chest CT with TB
  • Positive PPD test
  • Positive sputum test

Exclusion Criteria:

  • Females who are pregnant or nursing
  • History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic

Smokers with TB and COPD

Inclusion Criteria:

  • Must provide informed consent
  • Current smokers with COPD
  • Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease
  • Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed bu at least one of the following:
  • Symptoms consistent with TB
  • Chest xray and or chest CT consistent with TB
  • Positive PPD test
  • Positive sputum test

Exclusion Criteria:

  • Non-smokers
  • Females who are pregnant or nursing
  • History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic

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

Cohortes e Intervenciones

Grupo / Cohorte
Individuals with TB

Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:

  1. Symptoms consistent with TB
  2. Chest X-rays and or chest CT consistent with TB
  3. Positive PPD test
  4. Positive sputum test
Smokers

Active smoker as evidenced by self report and urine nicotine >30 ng/mL and urine cotinine >50 ng/mL

Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:

  1. Symptoms consistent with TB
  2. Chest X-rays and or chest CT consistent with TB
  3. Positive PPD test
  4. Positive sputum test
Non-smokers

Never smokers is defined as someone who has smoked < 100 cigarettes per lifetime and whose urine nicotine <2 ng/mL and urine cotinine <5 ng/mL, at entry into the study

Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:

  1. Symptoms consistent with TB
  2. Chest X-rays and or chest CT consistent with TB
  3. Positive PPD test
  4. Positive sputum test
Individuals with COPD

All study subjects should meet the "Lung Disease" protocol criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure

Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:

  1. Symptoms consistent with TB
  2. Chest X-rays and or chest CT consistent with TB
  3. Positive PPD test
  4. Positive sputum test

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Alveolar Macrophage
Periodo de tiempo: 1 week
Changes in alveolar macrophage
1 week

Colaboradores e Investigadores

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

Patrocinador

Weill Medical College of Cornell University

Colaboradores

Hamad Medical Corporation
Weill Cornell Medical College in Qatar

Investigadores

  • Investigador principal: Ronald Crystal, MD, Weill Medical College of Cornell University

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

1 de enero de 2014

Finalización primaria (Anticipado)

1 de octubre de 2016

Finalización del estudio (Anticipado)

1 de octubre de 2016

Fechas de registro del estudio

Enviado por primera vez

22 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

19 de diciembre de 2013

Publicado por primera vez (Estimar)

27 de diciembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de mayo de 2017

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

23 de mayo de 2017

Última verificación

1 de mayo de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 14-00055 [JIRB]
  • NPRP 5-400-3-107 (Otro identificador: Qatar National Research Fund)
  • 11262/11 (Otro identificador: HMC IRB)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

All results of the proposed studies will be published in international peer-reviewed scientific journals, presented at meetings in Qatar, the regional and international conferences, and disseminated through the local Qatari media, seminars and lectures for high school and college students. The original data will be available to interested investigators using the conventional standards of biomedical science.

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. .

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