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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source |
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This study plans to learn more about the effect of oral antibiotics for an outpatient pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung function, airway inflammation and quality of life. In this study subjects will perform pulmonary function tests, provide a sputum sample and complete a questionnaire at two separate clinic visits. If a subject is unable to cough up sputum in clinic he or she will be asked to breathe in a salt water solution to help cough up sputum. The first sputum sample will be obtained at the first visit (within 48 hours of starting antibiotics). Pulmonary function testing and the questionnaire will also be completed at this time. Subjects will complete a two week course of oral antibiotics at home. During these two weeks subjects will be asked to write down the times antibiotics are taken and airway clearance (vest treatment) is performed. Within one week of completing the antibiotic course subjects will return to clinic for a second visit. At that time a sputum sample will be obtained again and if subjects are unable to cough up sputum they will again be asked to breathe in salt water solution to help cough up sputum. Pulmonary function testing and the questionnaire will also be completed at this second visit. Sputum samples will be tested for infections with bacteria and viruses. Sputum samples will also be used to measure markers of airway inflammation (swelling). The investigators hypothesize that the use of two weeks of oral antibiotics for the treatment of a pulmonary exacerbation will result in a decrease in the amount of bacteria measured in sputum. Additionally the investigators hypothesize that treatment with antibiotics will lead to an improvement in lung function, a decrease in airway inflammation and an improvement in quality of life measurements.
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in bacterial colony count in the primary cystic fibrosis (CF) pathogen identified on culture | Quantitative measurements of the primary CF pathogen will be obtained on sputum culture at visits 1 and 2. The change in colony count (measured on the log scale) will be used as the primary outcome. | Baseline and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function |
| Baseline and 3 weeks |
| Airway inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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30 patients with cystic fibrosis will be recruited from the University of Colorado and Children's Hospital Colorado pediatric cystic fibrosis clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Jordana E Hoppe, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Change in measurements of sputum total white blood cell count, neutrophil count, neutrophil elastase, LTB4 (leukotriene B4), IL-8 (interleukin 8), IL-1B (interleukin 1, beta) |
| Baseline and 3 weeks |
| Quality of Life | Change in patient reported symptoms and severity (Cystic Fibrosis Questionnaire-Revised) | Baseline and 3 weeks |
| Microbiome | Change in airway microbiota in sputum samples obtained before and after oral antibiotics | Baseline and 3 weeks |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |