PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

Last updated: March 30, 2024
Sponsor: National Jewish Health
Overall Status: Active - Enrolling

Phase

N/A

Condition

Cystic Fibrosis

Scar Tissue

Lung Disease

Treatment

N/A

Clinical Study ID

NCT02073409
NTM-OB-17 (PREDICT PART A)
  • Ages 6-99
  • All Genders

Study Summary

Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to the diagnosis of NTM disease has been identified as one of the greatest unmet needs within the CF community. Current evidence predicts that the prevalence of NTM will remain relatively high in the CF population. Approaches to NTM disease diagnosis differ widely between centers. This study is observational and follows current best practices. The study will help standardize the diagnosis and collect relevant data associated with the diagnosis of NTM disease to build a framework for future therapeutic trials.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent (and assent when applicable) obtained from participant orparticipant's legal representative
  2. Enrolled in the CFF Patient Registry (CFF PR)
  3. Be willing and able to adhere to study procedures in the context of clinical care, andother protocol requirements
  4. Male or female participant ≥ 6 years of age at enrollment
  5. Diagnosis of CF consistent with the 2017 CFF Guidelines
  6. NTM positive for a species or sub-species in the 2 years prior to enrollment that hasnever been treated.
  7. Willing to discontinue chronic azithromycin use for the duration of the study

Exclusion

Exclusion Criteria:

  1. Prior or ongoing antibiotic treatment of the same NTM species or sub-species for whichthe patient is being considered for this study
  2. History of solid organ or hematological transplantation
  3. Has any other condition that, in the opinion of the Site Investigator/designee, wouldpreclude informed consent or assent, make study participation unsafe, complicateinterpretation of study outcome data, or otherwise interfere with achieving the studyobjectives

Study Design

Total Participants: 200
Study Start date:
December 01, 2013
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • CFF Pediatric Program, University of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Children's Hospital of Los Angeles

    Los Angeles, California
    United States

    Site Not Available

  • University of California San Diego

    San Diego, California
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois
    United States

    Site Not Available

  • Tulane University

    New Orleans, Louisiana
    United States

    Site Not Available

  • CFF Adult Program, Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Boston Children's Hospital, Brigham & Women's Hospital

    Boston, Massachusetts
    United States

    Site Not Available

  • CFF Pediatric Program University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire
    United States

    Site Not Available

  • CFF Pediatric Program, Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • CFF Adult Program, University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75390-8558
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont
    United States

    Site Not Available

  • CFF Adult Program, University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • CFF Pediatric Program Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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