| NCT ID | NCT06266442 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Mycobacterium Avium |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 40 participants in total. It began in 2024-05-13 with a primary completion date of 2026-09.
⚠ 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
This is a prospective observational study using whole genome sequencing (WGS) to investigate whether new strains (other than the initially identified strain(s)) of M. avium are responsible for persistently culture positive sputum during treatment (refractory disease), or the reversion to culture positive sputum after prior conversion to negative. The study will further investigate for differences between participants living in the Toronto/York region versus participants living elsewhere. The primary goal of this prospective observational study is to understand why some patients with M. avium lung disease have persistent or recurrent M. avium in their sputum despite treatment. The aim is to understand whether it is usually due to treatment failure or new infection.
Eligibility 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
Contact & Investigator
Theodore Marras, MD
PRINCIPAL INVESTIGATOR
UHN
Frequently Asked Questions
Who can join the NCT06266442 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mycobacterium Avium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06266442 currently recruiting?
Yes, NCT06266442 is actively recruiting participants. Contact the research team at ted.marras@uhn.ca for enrollment information.
Where is the NCT06266442 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06266442 clinical trial?
NCT06266442 is sponsored by University Health Network, Toronto. The principal investigator is Theodore Marras, MD at UHN. The trial plans to enroll 40 participants.