M. Avium WGS During Mav-PD Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients at the Toronto Western Hospital (TWH) Nontuberculous Mycobacterial (NTM) clinic who are to be initiated on therapy for Mav-PD.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Whole genome sequencing testing

    Other intervention

    Whole genome sequencing

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy

Whole genome sequencing

Time frame
24 months

Secondary outcomes

1

Whether patients with Mav-PD have evidence of polyclonal infection as demonstrated by the presence of >1 strain of M. avium in the pre-treatment sputum or a sputum sample during treatment

Whole genome sequencing

Time frame
24 months
2

Whether there is a source of infection from the home water environment

M. avium strains from sputum and home water source samples will determined through WGS analysis.

Time frame
24 months

Other outcomes

Sponsors and contacts

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University Health Network, Toronto

Lead sponsor

Western University, Canada

Collaborator

Public Health Ontario Laboratory, Canada

Collaborator