NCT02779478 Evaluation Of The Lung Microbiome In NTM Bronchiectasis
| NCT ID | NCT02779478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Nontuberculous Mycobacteria |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2014-10-01 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2014-10-01 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) * 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.
Contact & Investigator
Lisa Guiterrez
✉ Lira.Gutierrez@nyulangone.orgLeopoldo Segal, MD
PRINCIPAL INVESTIGATOR
New York University Medical School
Frequently Asked Questions
Who can join the NCT02779478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nontuberculous Mycobacteria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02779478 currently recruiting?
Yes, NCT02779478 is actively recruiting participants. Contact the research team at Lira.Gutierrez@nyulangone.org for enrollment information.
Where is the NCT02779478 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT02779478 clinical trial?
NCT02779478 is sponsored by NYU Langone Health. The principal investigator is Leopoldo Segal, MD at New York University Medical School. The trial plans to enroll 1,000 participants.