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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
| Children's Hospital Colorado | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF patients | Male and female subjects with CF age 6 years and older who meet diagnostic criteria for NTM disease through participation in the PREDICT (Part A) study who are being offered NTM treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion who adhere to the protocol based on: number of respiratory cultures obtained per year, withdrawals or major deviations from protocol | 12 months following end of antibiotic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration and combinations of NTM treatment regimens received | At end of treatment interval | |
| Proportion requiring antibiotic course change due to intolerance or lack of microbiological conversion (i.e. eradication from sputum) | At end of treatment interval |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects with CF age 6 years and older with a confirmed diagnosis of NTM disease who are initiating treatment for NTM.
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| Name | Affiliation | Role |
|---|---|---|
| Jerry A Nick, MD | National Jewish Health | Principal Investigator |
| Stacey Martiniano, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CFF Pediatric Program, University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital of Los Angeles |
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Samples collected may include serum, sputum, whole blood, breath, urine, and NTM isolates.
| Proportion who complete ≥ 12 months of treatment since first negative culture | At end of treatment interval |
| Proportion eradicating NTM defined by ≥ 12 months of negative cultures since end of treatment | 12 months following end of treatment |
| Variability between sites for NTM eradication success | 12 months following end of treatment |
| Time to treatment discontinuation due to treatment success | 12 months following end of treatment |
| Clinical outcomes (FEV1, growth parameters, CFQ-R) | 12 months following end of treatment |
| Los Angeles |
| California |
| United States |
| University of California San Diego | San Diego | California | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| University of Florida | Gainesville | Florida | United States |
| Northwestern University | Chicago | Illinois | United States |
| CFF Adult Program, Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Boston Children's Hospital, Brigham & Women's Hospital | Boston | Massachusetts | United States |
| CFF Pediatric Program University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States |
| CFF Pediatric Program, Columbia University | New York | New York | 10032 | United States |
| CFF Adult Program, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27517 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | United States |
| CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390-8558 | United States |
| University of Vermont Medical Center | Burlington | Vermont | United States |
| CFF Pediatric Program Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| CFF Adult Program, University of Washington | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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