RECRUITINGOBSERVATIONAL

Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD)

An Observational Cross-sectional Study Exploring Differences in Health Between People With Non-Tuberculous Mycobacteria Pulmonary Disease and People With Bronchiectasis Without NTM Pulmonary Infection.

About This Trial

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 long-term lung problems such as chronic obstructive pulmonary disease (COPD), bronchiectasis, or cystic fibrosis. The number of people with NTM pulmonary disease (PD) is increasing, and its management can be complex, requiring prolonged treatment with multiple, often toxic, drugs in someone who may already be frail. Non-drug approaches, such as airway clearance techniques, structured exercise, nutritional support and psychological care are used to help manage bronchiectasis and COPD. However, there is limited evidence about their benefit in people with NTM-PD. Also, it is not clear whether these patients' health needs are different from people with bronchiectasis alone. The investigators want to identify the most important symptoms encountered by people with NTM-PD and patient preferences for care. The study also aims to explore whether the need for non-drug measures differs between people with and without NTM-PD who have other underlying lung disease. The research will take place at one NHS centre and involve a single assessment of 40 people with NTM-PD not using specific antibiotics to treat their NTM and 40 people with bronchiectasis but no evidence for NTM. Following consent, and mainly using questionnaires, participants will be asked about their physical and mental health, and nutritional status. Exercise capacity, muscle strength and body muscle/fat composition will also be assessed using simple tests. The total time required will be a maximum of one hour. Recruitment to the study will last around six months. The results will help improve understanding of specific needs of people with NTM-PD and guide clinically relevant research in this area.

Who May Be Eligible (Plain English)

Who May Qualify: \- Age: 18 years or older, able to provide willing to sign a consent form. 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. Who Should NOT Join This Trial: \- Age: Under 18 years of age, or unable to provide willing to sign a consent form. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: \- 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 Criteria: \- 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.

Locations (1)

Royal Free London NHS Foundation Trust

London, United Kingdom