Status:
RECRUITING
Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD)
Lead Sponsor:
University College, London
Collaborating Sponsors:
Royal Free Hospital NHS Foundation Trust
Conditions:
Non-Tuberculous Mycobacteria Pulmonary Disease
Bronchiectasis
Eligibility:
All Genders
18+ years
Brief Summary
Nontuberculous mycobacteria (NTM) are environmental organisms found in soil and water. The majority do not cause human disease. When they do, this is mostly as a chronic lung infection in people with ...
Detailed Description
Nontuberculous mycobacteria are environmental organisms primarily found in soil and water, including locations such as lakes, rivers, agricultural zones, and some industrial sites. Environmental chang...
Eligibility Criteria
Inclusion
- \- Age: 18 years or older, able to provide informed consent.
- NTM-PD Group:
- Participants will be adults diagnosed with confirmed NTM-PD based on the British Thoracic Society (BTS) guidelines.
- The participant should not be on any antimicrobial therapy (at least two weeks before participation) and should not have previously received or be currently on antimicrobial therapy for NTM-PD.
- \* BTS guidelines:
- Clinical (both required):
- Pulmonary symptoms, nodular or cavitary opacities on chest radiograph, or a high-resolution CT scan that shows multifocal bronchiectasis with multiple small nodules.
- Appropriate exclusion of other diagnoses.
- Microbiological:
- A minimum of two positive expectorated sputum culture results of the same NTM species from samples collected on separate days within 12 months before recruitment.
- OR
- Positive culture results from at least one bronchial wash or lavage. OR
- Transbronchial or other lung biopsy with mycobacterial histopathological features (granulomatous inflammation or AFB) and positive culture for NTM or biopsy showing mycobacterial histopathological features (granulomatous inflammation or AFB) and one or more sputum or bronchial washings that are culture-positive for NTM.
- Bronchiectasis Group:
- Diagnosed with bronchiectasis, as confirmed in medical records based on clinical assessment, and radiological findings.
- Never had a history of positive culture result for NTM pulmonary infection.
- The latest NTM-negative result must be within the past 12 months from the study's start date or no earlier than 2024.
Exclusion
- \- Age: Under 18 years of age, or unable to provide informed consent.
- NTM-PD Group:
- No confirmation of NTM-PD diagnosis.
- Diagnosed with a reinfection of NTM-PD.
- Started antimicrobial therapy for NTM-PD.
- Bronchiectasis Group:
- No diagnosis of bronchiectasis or diagnosis of bronchiectasis with NTM-PD.
- Diagnosed with other chronic respiratory diseases considered primary conditions, rather than bronchiectasis.
- Participants with a history of NTM pulmonary infection.
- NTM-negative results obtained before 2024.
Key Trial Info
Start Date :
August 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07192705
Start Date
August 14 2025
End Date
June 1 2026
Last Update
September 25 2025
Active Locations (1)
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1
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG