PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

Status unconfirmed

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02073409

Run by

National Jewish Health

People needed

200

Starts

2013-12-01

Expected to finish

2025-03-01

Last updated by the study team

2024-04-02

Who can join

Age: 6 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
• Enrolled in the CFF Patient Registry (CFF PR)
• Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
• Male or female participant ≥ 6 years of age at enrollment
• Diagnosis of CF consistent with the 2017 CFF Guidelines
• NTM positive for a species or sub-species in the 2 years prior to enrollment that has never been treated.
• Willing to discontinue chronic azithromycin use for the duration of the study

You may not qualify if…

• Prior or ongoing antibiotic treatment of the same NTM species or sub-species for which the patient is being considered for this study
• History of solid organ or hematological transplantation
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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