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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Cystic Fibrosis Pseudomonas Aeruginosa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cayston Only Cohort

This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month.

No interventions assigned to this group

Tobi Only Cohort

This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month.

No interventions assigned to this group

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

No interventions assigned to this group

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

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No