Clincosm LogoSign in Get a demo

PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

Sponsor
National Jewish Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT02073409
Collaborator
Cystic Fibrosis Foundation (Other), Children's Hospital Colorado (Other)
200
Enrollment
20
Locations
110.9
Duration (Months)
10
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis
    Study Start Date :
    Dec 1, 2013
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    CF patients

    Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion meeting the diagnosis of NTM disease [12 months intervals following study enrollment]

    Secondary Outcome Measures

    1. Adherence to PREDICT protocol: number of respiratory cultures obtained per participant per year, withdrawals and major deviations from protocol [12 months intervals following study enrollment]

    2. Incidence and prevalence of NTM species/subspecies by geographical region [12 months intervals following study enrollment]

    3. Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site [12 months intervals following study enrollment]

    4. Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE [12 months intervals following study enrollment]

    5. Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R) [12 months intervals following study enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Written informed consent (and assent when applicable) obtained from participant or participant'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, and other protocol requirements

    4. Male or female participant ≥ 6 years of age at enrollment who are able to reliably expectorate sputum and/or willing to undergo sputum induction (if necessary)

    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 has never been treated.

    7. Willing to discontinue chronic azithromycin use for the duration of the study

    Exclusion Criteria:

    1. Prior or ongoing antibiotic treatment of the same NTM species or sub-species for which the 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, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CFF Pediatric Program, University of Alabama Birmingham Alabama United States 35233
    2 Children's Hospital of Los Angeles Los Angeles California United States
    3 University of California San Diego San Diego California United States
    4 Children's Hospital Colorado Aurora Colorado United States 80045
    5 National Jewish Health Denver Colorado United States 80206
    6 University of Florida Gainesville Florida United States
    7 Northwestern University Chicago Illinois United States
    8 Tulane University New Orleans Louisiana United States
    9 CFF Adult Program, Johns Hopkins University Baltimore Maryland United States 21205
    10 Boston Children's Hospital, Brigham & Women's Hospital Boston Massachusetts United States
    11 CFF Pediatric Program University of Michigan Ann Arbor Michigan United States 48109
    12 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States
    13 CFF Pediatric Program, Columbia University New York New York United States 10032
    14 CFF Adult Program, University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27517
    15 Nationwide Children's Hospital Columbus Ohio United States
    16 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States
    17 CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas Dallas Texas United States 75390-8558
    18 University of Vermont Medical Center Burlington Vermont United States
    19 CFF Pediatric Program Seattle Children's Hospital Seattle Washington United States 98105
    20 CFF Adult Program, University of Washington Seattle Washington United States 98195

    Sponsors and Collaborators

    • National Jewish Health
    • Cystic Fibrosis Foundation
    • Children's Hospital Colorado

    Investigators

    • Principal Investigator: Jerry A Nick, MD, National Jewish Health
    • Principal Investigator: Stacey Martiniano, MD, Children's Hospital Colorado

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jerry A. Nick, M.D., Professor of Medicine, National Jewish Health
    ClinicalTrials.gov Identifier:
    NCT02073409
    Other Study ID Numbers:
    • NTM-OB-17 (PREDICT PART A)
    First Posted:
    Feb 27, 2014
    Last Update Posted:
    May 13, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jerry A. Nick, M.D., Professor of Medicine, National Jewish Health
    Nontuberculous Mycobacteria
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of May 13, 2021