Investigating M. avium strains in lung disease treatment
Longitudinal Assessment of Clinical Pulmonary Mycobacterium Avium Isolates in Treated Patients Using Whole Genome Sequencing
University Health Network, Toronto · NCT06266442
This study looks at why some patients with lung disease keep getting M. avium infections during treatment by testing their sputum samples over time to see if it's due to treatment not working or new infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06266442 on ClinicalTrials.gov |
What this trial studies
This observational study uses whole genome sequencing (WGS) to explore the reasons behind persistent or recurrent M. avium infections in patients undergoing treatment for lung disease. It aims to determine if these issues are due to treatment failure or new infections by analyzing sputum samples collected from participants over time. Additionally, environmental samples will be collected to identify potential sources of infection. Participants will continue to receive standard care while their sputum samples are monitored and analyzed throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Mav-PD, either initial or recurrent, who have resided continuously in Ontario for the past five years.
Not a fit: Patients with severe comorbid illnesses, known macrolide-resistant MAC infections, or those residing in specific excluded regions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of persistent M. avium infections in lung disease patients.
How similar studies have performed: While this approach is novel in its specific focus on WGS for M. avium, similar studies have shown promise in understanding other infectious diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 and older * Willing to provide informed consent and participate in study procedures * Residing continuously in Ontario during the past five years * Mav-PD, either initial or recurrent (previously treated patients will be eligible) five years * Meet American Thoracic Society (ATS) / Infectious Diseases Society of America (IDSA) NTM disease criteria for Mav-PD Exclusion Criteria: * Lack of an available pre-treatment M. avium isolate in the PHOL isolate bank * The inability to produce sputum either spontaneously or by induction with nebulized hypertonic saline * Cavitation \>3 cm internal diameter * Known macrolide-resistant MAC infection * HIV infection * Known diagnosis of cystic fibrosis * History of solid organ or hematological transplantation * Severe comorbid illness that is reasonably expected to limit survival to \<24 months * Residing in mid/north York region (King, Aurora, Newmarket, Whitechurch-Stouffville, East Gwillimbury or Georgina) * Having moved between regions (Toronto/southern York region vs non-Toronto/York region vs mid-northern York region) within the past 5 years
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Theodore Marras, MD — UHN
- Study coordinator: Theodore Marras, MD
- Email: ted.marras@uhn.ca
- Phone: 416-603-5767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mycobacterium Avium, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous Mycobacterial Lung Disease, Respiratory Tract Diseases, Nontuberculous mycobacterium, Whole genome sequencing, Mycobacterium avium