Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome (NCT05277857) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome
United States109 participantsStarted 2020-09-20
Plain-language summary
Mycobacterial Lung Diseases in Virginia: sequencing and clinical determinants of relapse and outcome
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 particip…