Studies airway bacteria in people with lung infection and bronchiectasis
Compares airway bacteria in people suspected of nontuberculous mycobacteria lung disease.
Key facts
- Who runs it
- NYU Langone Health
- Where
- New York, United StatesSee the site
- Trial code
- Registry title
- Evaluation Of The Lung Microbiome In NTM Bronchiectasis
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 1 Oct 2014
- Expected to end
- Jul 2031
- Type of study
- Observational, 2 groups
- Treatments tested
- Bronchoscopy
- Record updated
- 27 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who may have a lung infection with nontuberculous mycobacteria (NTM), with lung symptoms and abnormal lung imaging. It studies the germs living in the airways.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Lung symptoms (such as cough, fatigue, fever, weight loss, shortness of breath, coughing up blood or chest discomfort) and abnormal imaging within 2 years. Cases have NTM-positive cultures; controls do not.
- Earlier treatment
- No oral antibiotics or steroids in the last 1 month. Long-term macrolides and inhaled steroids are accepted if started more than 1 month before.
- Biomarker or test result
- NTM culture results: at least two positive sputum samples, or one positive BAL or lung biopsy, for cases.
Main reasons for not taking part
- Recent smoking
- Oral antibiotic or steroid use in the last 1 month
- For the bronchoscopy part: FEV1 below 70% of predicted
- For the bronchoscopy part: heart disease, diabetes, serious liver or kidney disease, severe clotting problems
- For the bronchoscopy part: pregnancy, heavy alcohol use, or unable to give informed consent
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Recent (<1 months prior) oral antibiotic or steroid use. (Continuous treatment with macrolides and inhaled steroids are acceptable >1 month prior)
- 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)
- Recent smoking history
- Forced expiratory volume at one second (FEV1) < 70%of predicted
- Pregnancy
- Ethanol (ETOH) use of more than >6 beers or >4 mixed drinks daily
- Lack of capacity to provide informed consent
Where in United States
- New York University School of MedicineNew York, United StatesContact: Maria Tarallo, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 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
Treatment: Bronchoscopy
- 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.
Treatment: Bronchoscopy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation Of The Lung Microbiome In NTM Bronchiectasis
- Plain-language title
- Studies airway bacteria in people with lung infection and bronchiectasisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 February 2026