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

Running, not enrolling

Conditions studied: Nontuberculous Mycobacterial Lung Disease

In brief

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

Key facts

Study ID

NCT05277857

Run by

University of Virginia

People needed

109

Starts

2020-09-20

Expected to finish

2026-06-30

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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