PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT02073409
- Lead Sponsor
- National Jewish Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion meeting the diagnosis of NTM disease 12 months intervals following study enrollment
- Secondary Outcome Measures
Name Time Method 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 Incidence and prevalence of NTM species/subspecies by geographical region 12 months intervals following study enrollment Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R) 12 months intervals following study enrollment Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE 12 months intervals following study enrollment Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site 12 months intervals following study enrollment
Trial Locations
- Locations (19)
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 Adult Program, University of Washington
🇺🇸Seattle, Washington, United States
Boston Children's Hospital, Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, 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
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
CFF Pediatric Program University of Michigan
🇺🇸Ann Arbor, Michigan, United States
CFF Adult Program, Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
CFF Pediatric Program Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
CFF Pediatric Program, University of Alabama
🇺🇸Birmingham, Alabama, United States
University of California San Diego
🇺🇸San Diego, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States