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

Completed

• Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

• Registration Number: NCT01319253
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Primary Completion: 2012-07
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibiotic Resistance Profiles	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 Outcome Measures

Name	Time	Method
Clinical Symptoms	Every 3 months within a 12 month period	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.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States