Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Antibiotic Resistance Profiles
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Antibiotic Resistance Profiles
Time Frame: Every three months within a 12 month period
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.
Secondary Outcomes
- Clinical Symptoms(Every 3 months within a 12 month period)
Investigators
Michelle Howenstine
Professor of Clinical Pediatrics
Indiana University