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 Type
OBSERVATIONAL
Enrollment
200
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
...and 9 more locations
Proportion meeting the diagnosis of NTM disease
Time frame: 12 months intervals following study enrollment
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
Incidence and prevalence of NTM species/subspecies by geographical region
Time frame: 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
Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE
Time frame: 12 months intervals following study enrollment
Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R)
Time frame: 12 months intervals following study enrollment
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