Evaluation Of The Lung Microbiome In NTM Bronchiectasis

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT02779478
Status
Recruiting
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Conditions

  • Bronchiectasis
  • Nontuberculous Mycobacteria

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bronchoscopy — PROCEDURE

Study Details

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.

Key Dates

Start date
Oct 1, 2014
Status verified
Feb 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.

Primary Outcome Measure

Evaluation of airway microbiome in subjects with active pulmonary NTM disease and compare with controls [ Time Frame: 4 Hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016
Maria Tarallo, MD
[email protected]
Adrienne Scott
[email protected]
Leopoldo Segal, MD (PRINCIPAL_INVESTIGATOR)
Stephanie Lau, MD (SUB_INVESTIGATOR)
Milan Amin, MD (SUB_INVESTIGATOR)
David Kamelhar, MD (SUB_INVESTIGATOR)
Doreen Addrizzo-Harris, MD (SUB_INVESTIGATOR)
Katrina Bantis, MD (SUB_INVESTIGATOR)
Benjamin Wu, MD (SUB_INVESTIGATOR)
Ashwin Basavaraj, MD (SUB_INVESTIGATOR)

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