Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Description

A biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will evaluate the airway microbiome using an aliquot of the induced sputum and upper airway samples. Since induced sputum may reflect different regions of the upper/lower airways, the investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.

Conditions

Nontuberculous Mycobacteria, Bronchiectasis

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Study Overview

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Study Details

Study overview

A biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will evaluate the airway microbiome using an aliquot of the induced sputum and upper airway samples. Since induced sputum may reflect different regions of the upper/lower airways, the investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.

Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Condition
Nontuberculous Mycobacteria
Intervention / Treatment

-

Contacts and Locations

New York

New York University School of Medicine, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * History of pulmonary symptoms: cough, fatigue, malaise, fever, weight loss, dyspnea, hemoptysis, or chest discomfort
  • * Imaging abnormalities (within 2 years): defined as nodular or cavitary opacities on chest radiograph, or a computed tomography scan that shows bronchiectasis or bronchial wall thickening with associated multiple small nodules.
  • * Subjects that meet inclusion criteria and have culture positivity for NTM: at least two separate expectorated induced sputum samples or from one bronchoalveolar lavage (BAL) or lung biopsy
  • * Subjects that meet inclusion criteria and have less than two separate expectorated induced sputum samples culture negative or culture negative bronchoalveolar lavage (BAL) or lung biopsy.
  • * Recent (\<1 months prior) oral antibiotic or steroid use. (Continuous treatment with macrolides and inhaled steroids are acceptable \>1 month prior)
  • * Recent smoking history
  • * Forced expiratory volume at one second (FEV1) \< 70%of predicted.
  • * Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
  • * Diabetes mellitus
  • * Significant liver or renal disease
  • * Severe coagulopathy (INR \> 1.4, Partial Thromboplastin Time (PTT) \> 40 seconds and platelet count \< 150x103 cells).
  • * Pregnancy
  • * Ethanol (ETOH) use of more than \>6 beers or \>4 mixed drinks daily
  • * Lack of capacity to provide informed consent.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Leopoldo Segal, MD, PRINCIPAL_INVESTIGATOR, New York University Medical School

Study Record Dates

2031-07