A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies

Study Overview
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Brief Summary
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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.

Official Title
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Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics

Conditions
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Cystic Fibrosis, Pseudomonas Aeruginosa

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cayston Only Cohort<br>This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month. | |
| Tobi Only Cohort<br>This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month. | |
| Cayston and Tobi Cohort<br>This Cohort will be on a previously established medication regiment that includes Cayston and Tobi inhaled antibiotic alternating every other month | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Pseudomonas aeruginosa