Actively Recruiting

Age: 18Years +
All Genders
NCT06266442

M. Avium WGS During Mav-PD Treatment

Led by University Health Network, Toronto · Updated on 2024-05-21

40

Participants Needed

1

Research Sites

120 weeks

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

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.

CONDITIONS

Official 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 Mycobacterium Avium pulmonary disease (Mav-PD), either initial or recurrent
  • Meet American Thoracic Society/Infectious Diseases Society of America criteria for 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 diameter
  • Known macrolide-resistant MAC infection
  • HIV infection
  • Diagnosis of cystic fibrosis
  • History of solid organ or blood transplantation
  • Severe illness expected to limit survival to less than 24 months
  • Living in mid/north York region (King, Aurora, Newmarket, Whitechurch-Stouffville, East Gwillimbury, Georgina)
  • Moved between Toronto/southern York region, non-Toronto/York region, or mid-northern York region in past 5 years

AI-Screening

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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

CONTACT

M

Matty Mehrabi, BSc, M.Ed

CONTACT

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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M. Avium WGS During Mav-PD Treatment | DecenTrialz