M. Avium WGS During Mav-PD Treatment

Recruiting now

Conditions studied: Mycobacterium Avium, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous Mycobacterial Lung Disease, Respiratory Tract Diseases

In brief

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.

Key facts

Study ID

NCT06266442

Run by

University Health Network, Toronto

People needed

40

Starts

2024-05-13

Expected to finish

2026-09-01

Last updated by the study team

2024-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• University Health Network — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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