Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266442
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2023-12-27
Brief Title:
M Avium WGS During Mav-PD Treatment
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Longitudinal Assessment of Clinical Pulmonary Mycobacterium Avium Isolates in Treated Patients Using Whole Genome Sequencing
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational study using whole genome sequencing WGS to investigate whether new strains other than the initially identified strains 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 TorontoYork 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
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 participants home environmental samples ie 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 participants sputum
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 participants home environmental samples ie 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 participants sputum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None