Actively Recruiting

Age: 18Years +
All Genders
ID06266442

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Sample Collection

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

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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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