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)

University of Virginia, Division of Infectious Disease

Charlottesville, Virginia, United States

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NCT05277857


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