Status:
RECRUITING
Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome
Lead Sponsor:
University of Virginia
Conditions:
Nontuberculous Mycobacterial Lung Disease
Eligibility:
All Genders
18+ years
Brief Summary
Mycobacterial Lung Diseases in Virginia: sequencing and clinical determinants of relapse and outcome
Detailed Description
Nontuberculous mycobacterial (NTM) lung diseases, primarily due to M. avium complex (MAC), are an increasing clinical problem nationwide and now overtake domestic TB in terms of morbidity and mortalit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT05277857
Start Date
September 20 2020
End Date
December 31 2026
Last Update
May 23 2022
Active Locations (1)
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1
University of Virginia, Division of Infectious Disease
Charlottesville, Virginia, United States, 22908