A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2011 |
| End Date: | October 2015 |
Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics
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.
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.
Inclusion Criteria:
- > or = to 6 years of age
- Documentation of Cf diagnosis
- History of PA present in sputum, on a least one occasion, during the 12 months prior
to Visit 1.
- Currently on inhaled antibiotic regiment
- Must be able to provide written informed consent or assent prior to any study related
procedures
- Ability to expectorate sputum
- Ability ro perform reproducible pulmonary function test
Exclusion Criteria:
- Administration of any IV or oral antipseudomonal antibiotic within 28 days prior to
Visit 1
- Any serious or active medical or psychiatric illness, which in the opinion of the
investigator, woud interfere with participant treatment, assessment, or compliance
with the protocol
- Current enrollment in an interventional clinical trial
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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