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Recruiting NCT02779478

Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Trial Parameters

Condition Nontuberculous Mycobacteria
Sponsor NYU Langone Health
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2014-10-01
Completion 2030-07
Interventions
Bronchoscopy

Brief Summary

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.

Eligibility Criteria

Inclusion 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. Definition of NTM case: * 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 Definition of NTM control: * 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. Exclusion Criteria for cohort study (Aim 1-2): * Recent (\<1 months prior) oral antibiotic or steroid use. (Continuous treatment with macrolides and inhaled steroids are acceptable \>1 month prior) *

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