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

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277857
Collaborator
(none)
720
Enrollment
1
Location
75.3
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 mortality. It is also harder to treat and results in poorer outcomes despite longer drug regimens. In this project we utilize a state-wide clinical cohort of NTM lung disease patients to understand what features of the organism (such as the species or subtype or drug resistance profile), the host (such as antibiotic drug absorption), and the environment (such as household exposure to NTM) are most important in predicting clinical outcome. The sum of this research will direct future therapies and management algorithms for this difficult disease.

    First, we will perform whole genome sequencing of NTM isolates to discern relapse versus reinfection and the environmental sources of acquisition. Second, we will utilize a state-wide cohort of new and prior diagnosed NTM lung disease patients, starting initial therapy to correlate clinical outcomes with NTM species, drug susceptibility, other bacterial in vitro assays, and serum drug levels.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    720 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome
    Actual Study Start Date :
    Sep 20, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Aim 1 [5 years]

      Relapse versus reinfection: Perform whole genome sequencing of NTM isolates from lung disease patients from across Virginia to discern relapse versus reinfection and environmental sources of acquisition.

    Secondary Outcome Measures

    1. Aim 2 [5 years]

      Patient outcomes: Utilizing the cohort of new and prior diagnosed NTM lung disease patients that have started initial therapy within the last 3 months from across Virginia, compare conventional drug susceptibility (MIC) versus pharmacokinetics/pharmacodynamics (PK/PD) indices in predicting NTM species-specific clinical outcomes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 participate in follow-up requirements by phone or clinic visit

    PK subjects:

    • Unable to have blood drawn for pharmacokinetic testing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Virginia, Division of Infectious Disease Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • University of Virginia

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric R. Houpt, MD, Chief of the Division of Infectious Diseases and International Health, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT05277857
    Other Study ID Numbers:
    • IRB200232
    First Posted:
    Mar 14, 2022
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases

    Study Results

    No Results Posted as of May 23, 2022