Actively Recruiting
Longitudinal Assessment of Clinical Pulmonary Mycobacterium Avium Isolates in Treated Patients Using Whole Genome Sequencing
Led by University Health Network, Toronto · Updated on 2024-05-21
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
W
Western University, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating why some patients with Mycobacterium avium pulmonary disease (Mav-PD) continue to have positive sputum cultures despite treatment or experience a return to positive cultures after initially testing negative. This observational study uses whole genome sequencing (WGS) to determine if new strains of M. avium are causing persistent or recurrent infections. The study also examines differences between participants living in the Toronto/York region and those living elsewhere. Participants will undergo WGS testing on M. avium isolates collected from their sputum before treatment and every three months during treatment until the sputum becomes culture-negative. If sputum cultures become positive again, those isolates will also be analyzed by WGS. Additionally, samples from the participants' home water environment, such as faucets and showerheads, will be collected and analyzed to see if the same strains are present. All participants will receive standard care treatment as determined by their doctors. During the study, participants will provide sputum samples monthly and home environmental samples will be collected. Researchers will analyze these samples to identify the presence of M. avium strains and to understand if infections are due to treatment failure or new infections. The primary outcome measures the proportion of patients with persistent positive sputum cultures over 24 months. Secondary outcomes include detecting multiple strains in sputum and identifying home sources of infection. The study will last up to 24 months, with ongoing monitoring of participants' sputum and environmental samples.
CONDITIONS
Brief Title
M. Avium WGS During Mav-PD Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and older
- Willing to provide informed consent and participate in study procedures
- Residing continuously in Ontario during the past five years
- Diagnosed with Mav-PD, including initial or recurrent cases
- Meet ATS/IDSA criteria for nontuberculous mycobacterial disease (Mav-PD)
You will not qualify if you...
- No available pre-treatment M. avium isolate in the PHOL isolate bank
- Unable to produce sputum spontaneously or by induction
- Lung cavitation larger than 3 cm in internal diameter
- Known macrolide-resistant MAC infection
- HIV infection
- Diagnosis of cystic fibrosis
- History of solid organ or blood-related transplantation
- Severe illness expected to limit survival to less than 24 months
- Residing in mid/north York region (King, Aurora, Newmarket, Whitechurch-Stouffville, East Gwillimbury, or Georgina)
- Moved between Toronto/southern York region, non-Toronto/York region, or mid-northern York region within past 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who undergo routine care are observed with monthly sputum sample submissions for testing and whole genome sequencing analysis of M. avium isolates.
Monthly visits for sputum sample submission
Duration - Up to 24 months
Home environmental samples such as faucets and showerhead biofilms are collected to identify potential sources of M. avium infection and analyzed by whole genome sequencing.
Additional sample collections as scheduled during the study
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G
Actively Recruiting
Research Team
T
Theodore Marras, MD
M
Matty Mehrabi, BSc, M.Ed
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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