Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-01

Study Completion Date

2031-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nontuberculous Mycobacteria Bronchiectasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive NTM Culture

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

Bronchoscopy

Intervention Type PROCEDURE

Negative NTM Culture

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.

Bronchoscopy

Intervention Type PROCEDURE

Interventions

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Bronchoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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:

Definition of NTM control:

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No