PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis
NCT ID: NCT02073409
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
200 participants
OBSERVATIONAL
2013-12-31
2025-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis
NCT02419989
Sputum Purulence as a Predictor of Cystic Fibrosis Exacerbations: a Prospective Cohort Trial.
NCT02309229
A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida
NCT02198079
Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria in Cystic Fibrosis
NCT04024423
Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
NCT00004296
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CF patients
Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
6 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cystic Fibrosis Foundation
OTHER
Children's Hospital Colorado
OTHER
National Jewish Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jerry A. Nick, M.D.
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jerry A Nick, MD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Stacey Martiniano, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CFF Pediatric Program, University of Alabama
Birmingham, Alabama, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
CFF Adult Program, Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, United States
CFF Pediatric Program University of Michigan
Ann Arbor, Michigan, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
CFF Pediatric Program, Columbia University
New York, New York, United States
CFF Adult Program, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
CFF Pediatric Program Seattle Children's Hospital
Seattle, Washington, United States
CFF Adult Program, University of Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Martiniano SL, Caceres SM, Poch K, Rysavy NM, Lovell VK, Armantrout E, Jones M, Anthony M, Keck A, Nichols DP, Vandalfsen JM, Sagel SD, Wagner B, Xie J, Weaver K, Heltshe SL, Daley CL, Davidson RM, Nick JA; Investigators of the Cystic Fibrosis NTM Consortium. Prospective evaluation of nontuberculous mycobacteria disease in cystic fibrosis: The design of the PREDICT study. J Cyst Fibros. 2024 Jan;23(1):50-57. doi: 10.1016/j.jcf.2023.08.007. Epub 2023 Sep 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NTM-OB-17 (PREDICT PART A)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.