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 treatment 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 treatment differ widely between centers, and expected outcomes are not known. This study is observational and follows current best practices. The study will help define response to treatment, and collect relevant data associated with treatment of NTM disease to build a framework for future therapeutic trials.
Study Type
OBSERVATIONAL
Enrollment
70
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 who adhere to the protocol based on: number of respiratory cultures obtained per year, withdrawals or major deviations from protocol
Time frame: 12 months following end of antibiotic treatment
Duration and combinations of NTM treatment regimens received
Time frame: At end of treatment interval
Proportion requiring antibiotic course change due to intolerance or lack of microbiological conversion (i.e. eradication from sputum)
Time frame: At end of treatment interval
Proportion who complete ≥ 12 months of treatment since first negative culture
Time frame: At end of treatment interval
Proportion eradicating NTM defined by ≥ 12 months of negative cultures since end of treatment
Time frame: 12 months following end of treatment
Variability between sites for NTM eradication success
Time frame: 12 months following end of treatment
Time to treatment discontinuation due to treatment success
Time frame: 12 months following end of treatment
Clinical outcomes (FEV1, growth parameters, CFQ-R)
Time frame: 12 months following end of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.