PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis (PREDICT)

March 30, 2024 updated by: Jerry A. Nick, M.D., National Jewish Health

Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • CFF Pediatric Program, University of Alabama
    • California
      • Los Angeles, California, United States
        • Children's Hospital of Los Angeles
      • San Diego, California, United States
        • University of California San Diego
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Gainesville, Florida, United States
        • University of Florida
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • CFF Adult Program, Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston Children's Hospital, Brigham & Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • CFF Pediatric Program University of Michigan
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10032
        • CFF Pediatric Program, Columbia University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • CFF Adult Program, University of North Carolina at Chapel Hill
    • Ohio
      • Columbus, Ohio, United States
        • Nationwide Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center
    • Texas
      • Dallas, Texas, United States, 75390-8558
        • CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas
    • Vermont
      • Burlington, Vermont, United States
        • University of Vermont Medical Center
    • Washington
      • Seattle, Washington, United States, 98105
        • CFF Pediatric Program Seattle Children's Hospital
      • Seattle, Washington, United States, 98195
        • CFF Adult Program, University of Washington

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.

Eligibility Criteria

Ages Eligible for Study

6 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion meeting the diagnosis of NTM disease
Time Frame: 12 months intervals following study enrollment
12 months intervals following study enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Adherence to PREDICT protocol: number of respiratory cultures obtained per participant per year, withdrawals and major deviations from protocol
Time Frame: 12 months intervals following study enrollment
12 months intervals following study enrollment
Incidence and prevalence of NTM species/subspecies by geographical region
Time Frame: 12 months intervals following study enrollment
12 months intervals following study enrollment
Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site
Time Frame: 12 months intervals following study enrollment
12 months intervals following study enrollment
Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE
Time Frame: 12 months intervals following study enrollment
12 months intervals following study enrollment
Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R)
Time Frame: 12 months intervals following study enrollment
12 months intervals following study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Jewish Health

Collaborators

Children's Hospital Colorado
Cystic Fibrosis Foundation

Investigators

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

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 Major Dates

Study Start

December 1, 2013

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimated)

February 27, 2014

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTM-OB-17 (PREDICT PART A)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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