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

NCT05277857 | Recruiting

• 1 other identifier: IRB200232
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

Mycobacterial Lung Diseases in Virginia: sequencing and clinical determinants of relapse and outcome

Conditions

Nontuberculous Mycobacterial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Aim 1

  Relapse versus reinfection: Perform whole genome sequencing of NTM isolates from lung disease patients from across Virginia to discern relapse versus reinfection and environmental sources of acquisition.

  5 years

Secondary Outcomes (1)

• Aim 2

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Observational study of patients with Nontuberculous Mycobacterial lung disease. A subset of newly and prior diagnosed NTM lung disease patients, that have started initial therapy within the last 3 months, and prior diagnosed NTM lung disease patients who have not been on therapy for at least 5 years, will be enrolled in the pharmacokinetics study (Aim 2).

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia, Division of Infectious Disease

Charlottesville, Virginia, 22908, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sputum or respiratory samples \& environmental samples

Central Study Contacts

Sharon F Johnson

CONTACT

434-982-3413; sfj8n@virginia.edu

Eric F Houpt, MD

CONTACT

434-924-5167; ERH6K@virginia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of Infectious Diseases and International Health

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: September 20, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

US (1)