Evaluation Of The Lung Microbiome In NTM Bronchiectasis
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis, Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | April 2016 |
| End Date: | July 2024 |
| Contact: | Maria Tarallo |
| Email: | taralm01@nyumc.org |
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.
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.
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)
- Recent smoking history
Exclusion Criteria for bronchoscopic study (Aims 3-4):
- 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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Leopoldo Segal, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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