Mycobacterium AviumNCT06266442
M. Avium WGS During Mav-PD Treatment
An observational study of Mycobacterium Avium and Mycobacterium Infections, Nontuberculous, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections
- What is being tested?
- Whole genome sequencing testing
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 13 May 2024to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients at the Toronto Western Hospital (TWH) Nontuberculous Mycobacterial (NTM) clinic who are to be initiated on therapy for Mav-PD.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G
Matty Mehrabi, B.Sc. M. Ed, 416-603-5726, matty.mehrabi@uhn.ca
Theodore Marras, MD
About this study
Official title: Longitudinal Assessment of Clinical Pulmonary Mycobacterium Avium Isolates in Treated Patients Using Whole Genome Sequencing
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.
Read the detailed description
Mycobacterium Avium complex (MAC) are a subset of nontuberculous mycobacteria (NTM) that are typically found in the soil and water and can cause pulmonary lung disease. Treatment of MAC is challenging as it typically requires the use of three or more antibiotics for over a long period of time and the rate of eradication is suboptimal.
Mac-WGS is an observational study that aims to understand whether new strains of M. avium are responsible for persistently culture-positive sputum during treatment. Whole genome sequencing (WGS) will be performed on M. avium isolates from the sputum of patients with Mav-PD, over the duration of the study. Additionally, home environmental samples will be collected and sequenced to identify any home source of infection.
As an observational study, participants will receive routine standard of care treatment as per discretion of the physician. Standard of care includes monthly sputum submissions. The M. avium isolated from the sputum before treatment and every three months while on treatment (until such time that the sputum becomes culture-negative) will be analyzed by WGS. If sputum becomes culture-positive again, the isolated germ will also be analyzed by whole genome sequencing. It will be determined whether the identical strain of M. avium is always present or whether more than one strain is present which would suggest either multi-strain infection or the acquisition of new strains of M. avium while on treatment. Additionally, participant's home environmental samples (i.e. faucets and showerhead biofilms) will be cultured to determine whether M. avium can be recovered and if so, it will be analyzed with WGS to assess whether it is the same strain as in the participant's sputum.
- Conditions
- Mycobacterium Avium, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous Mycobacterial Lung Disease, Respiratory Tract Diseases
- Being tested
- Whole genome sequencing testing
- Keywords
- Nontuberculous mycobacterium, Whole genome sequencing, Mycobacterium avium
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole genome sequencing testingOther
Whole genome sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy
Whole genome sequencing
Measured: 24 months
Secondary outcomes (2)
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
Measured: 24 months
Whether there is a source of infection from the home water environment
- avium strains from sputum and home water source samples will determined through WGS analysis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start13 May 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium AviumStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada, Public Health Ontario Laboratory, Canada
- Responsible party
- Principal investigator, Theodore (Ted) Marras, University Health Network, Toronto
- Investigators
- Theodore Marras, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266442
- Sponsor's protocol ID
- Mav-WGS
- Status last verified
- May 2024
- First submitted
- 27 Dec 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Clinical Pulmonary Mycobacterium Avium Isolates in Treated Patients Using Whole Genome Sequencing
- ClinicalTrials.gov ID
- NCT06266442
- Acronym / sponsor ID
- Mav-WGS
- Conditions
- Mycobacterium Avium, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous Mycobacterial Lung Disease, Respiratory Tract Diseases
- Keywords
- Nontuberculous mycobacterium, Whole genome sequencing, Mycobacterium avium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Western University, Canada, Public Health Ontario Laboratory, Canada
- Study start
- 13 May 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mycobacterium Avium complex (MAC) are a subset of nontuberculous mycobacteria (NTM) that are typically found in the soil and water and can cause pulmonary lung disease. Treatment of MAC is challenging as it typically requires the use of three or more antibiotics for over a long period of time and the rate of eradication is suboptimal.
Mac-WGS is an observational study that aims to understand whether new strains of M. avium are responsible for persistently culture-positive sputum during treatment. Whole genome sequencing (WGS) will be performed on M. avium isolates from the sputum of patients with Mav-PD, over the duration of the study. Additionally, home environmental samples will be collected and sequenced to identify any home source of infection.
As an observational study, participants will receive routine standard of care treatment as per discretion of the physician. Standard of care includes monthly sputum submissions. The M. avium isolated from the sputum before treatment and every three months while on treatment (until such time that the sputum becomes culture-negative) will be analyzed by WGS. If sputum becomes culture-positive again, the isolated germ will also be analyzed by whole genome sequencing. It will be determined whether the identical strain of M. avium is always present or whether more than one strain is present which would suggest either multi-strain infection or the acquisition of new strains of M. avium while on treatment. Additionally, participant's home environmental samples (i.e. faucets and showerhead biofilms) will be cultured to determine whether M. avium can be recovered and if so, it will be analyzed with WGS to assess whether it is the same strain as in the participant's sputum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients at the Toronto Western Hospital (TWH) Nontuberculous Mycobacterial (NTM) clinic who are to be initiated on therapy for Mav-PD.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole genome sequencing testingWhole genome sequencing | Other | – |
Primary outcome
Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy
Time frame: 24 months
Whole genome sequencing
2 secondary outcomes
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
Time frame: 24 months
Whether there is a source of infection from the home water environment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Marras, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Avium and Mycobacterium Infections, Nontuberculous, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theodore Marras, MD (416-603-5767, ted.marras@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.