Understanding Mycobacterial Lung Diseases in Virginia

Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome

This study is trying to understand how different factors affect people with nontuberculous mycobacterial lung diseases in Virginia to help improve treatment and management.

Quick facts

• Study type: Observational
• Enrollment: 720 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Virginia (Academic / other)
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT05277857 on ClinicalTrials.gov

What this trial studies

This study focuses on nontuberculous mycobacterial (NTM) lung diseases, particularly those caused by the M. avium complex, which are increasingly problematic in terms of morbidity and mortality. Researchers will analyze a state-wide cohort of NTM lung disease patients to identify key factors influencing clinical outcomes, including organism characteristics, host factors, and environmental exposures. Whole genome sequencing of NTM isolates will be performed to differentiate between relapse and reinfection, while correlating clinical outcomes with various biological and environmental data. The findings aim to inform future treatment strategies and management protocols for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates include individuals with a confirmed diagnosis of NTM lung disease who have provided or are willing to provide a sputum sample.

Not a fit: Patients with a history of active tuberculosis in the last two years will not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved treatment strategies and better clinical outcomes for patients with NTM lung diseases.

How similar studies have performed: While there is ongoing research in this area, this specific approach utilizing whole genome sequencing and a state-wide cohort is relatively novel.

Eligibility criteria

Inclusion Criteria:

* All subjects:

  * Race/ethnicity: any
  * Subject has no history of active Tuberculosis in the last 2 years.
  * NTM culture positive from respiratory specimen (sputum or bronchial lavage fluid)
  * Subject must have an available sputum sample that was taken in the last 2 years. If a sample is not available, the subject must be willing and able to provide a sputum sample.
  * Meets the following Infectious Diseases Society of America (IDSA) criteria for NTM lung disease:

    * 2 or more sputum (or 1 bronchoscopy/biopsy) cultures positive for "Mycobacterium Avium Complex" or "Mycobacterium abscessus) within the last 2 years.
    * Nodules, cavities, and/or bronchiectasis on CT scan within the past 2 years
    * If if the above data are not available, but a patient's Infectious Disease or Pulmonary physician has documented the diagnosis of NTM lung disease in their notes, this will suffice

PK subjects:

* Newly diagnosed with NTM lung disease and beginning antibiotics for NTM within the last 3 months from enrollment.
* Prior diagnosis of NTM lung disease, and starting initial therapy within the last 3 months prior to enrollment.
* Consent to pharmacokinetic testing within one month of enrollment and at six months of therapy

Exclusion Criteria:

* List the criteria for exclusion

All subjects:

* Age \< 18 years
* Subject has cystic fibrosis or other inherited disorders of airway ciliary dysfunction (eg, primary ciliary dyskinesia)
* Unable to participate in follow-up requirements by phone or clinic visit

PK subjects:

• Unable to have blood drawn for pharmacokinetic testing

Where this trial is running

Charlottesville, Virginia

• University of Virginia, Division of Infectious Disease — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Sharon F Johnson

Conditions Nontuberculous Mycobacterial Lung Disease