RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-09-20
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05277857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All subjects:
  2. * Race/ethnicity: any
  3. * Subject has no history of active Tuberculosis in the last 2 years.
  4. * NTM culture positive from respiratory specimen (sputum or bronchial lavage fluid)
  5. * 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.
  6. * Meets the following Infectious Diseases Society of America (IDSA) criteria for NTM lung disease:
  7. * 2 or more sputum (or 1 bronchoscopy/biopsy) cultures positive for "Mycobacterium Avium Complex" or "Mycobacterium abscessus) within the last 2 years.
  8. * Nodules, cavities, and/or bronchiectasis on CT scan within the past 2 years
  9. * 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
  10. * Newly diagnosed with NTM lung disease and beginning antibiotics for NTM within the last 3 months from enrollment.
  11. * Prior diagnosis of NTM lung disease, and starting initial therapy within the last 3 months prior to enrollment.
  12. * Consent to pharmacokinetic testing within one month of enrollment and at six months of therapy
  1. * List the criteria for exclusion
  2. * Age \< 18 years
  3. * Subject has cystic fibrosis or other inherited disorders of airway ciliary dysfunction (eg, primary ciliary dyskinesia)
  4. * Unable to participate in follow-up requirements by phone or clinic visit

Contacts and Locations

Study Contact

Sharon F Johnson
CONTACT
434-982-3413
sfj8n@virginia.edu
Eric F Houpt, MD
CONTACT
434-924-5167
ERH6K@virginia.edu

Study Locations (Sites)

University of Virginia, Division of Infectious Disease
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-20
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-09-20
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Nontuberculous Mycobacterial Lung Disease