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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cayston Only Cohort | This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month. | ||
| Tobi Only Cohort | This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month. | ||
| Cayston and Tobi Cohort | This Cohort will be on a previously established medication regiment that includes Cayston and Tobi inhaled antibiotic alternating every other month |
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| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Resistance Profiles | The primary endpoint will be a change in the microbial resistance profile of pseudomonas aeruginosa (PA)isolates, change in PA sputum density, minimum inhibitory concentration of aztreonam and tobramycin for PA and the appearance or disappearance of other pathogens. | Every three months within a 12 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Symptoms | Secondary endpoint will be the change in clinical symptoms as assessed by the respiratory symptoms domain of the Cystic Fibrosis Questionnaire -Revised (CFQ-R),changes in pulmonary function Forced Exhaled Volume 1 second (FEV1) and change in frequency of hospitalizations or need for intravenous antibiotics. | Every 3 months within a 12 month period |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Michelle S Howenstine, MD | Indiana University | Principal Investigator |
| Gregory Anderson, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |