RecruitingNCT05277857
Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome
Sponsor
University of Virginia
Enrollment
720 participants
Start Date
Sep 20, 2020
Study Type
OBSERVATIONAL
Conditions
Summary
Mycobacterial Lung Diseases in Virginia: sequencing and clinical determinants of relapse and outcome
Eligibility
Min Age: 18 Years
Inclusion Criteria13
- 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
Exclusion Criteria7
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05277857