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

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis; Pseudomonas Aeruginosa

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Indiana University

Official(s) and/or principal investigator(s):
Michelle S Howenstine, MD, Principal Investigator, Affiliation: Indiana University
Gregory Anderson, PhD, Principal Investigator, Affiliation: Indiana University


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 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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Antibiotic Resistance Profiles

Secondary outcome: Clinical Symptoms


Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Indiana University, Indianapolis, Indiana 46202, United States
Additional Information

Starting date: March 2011
Last updated: April 11, 2012

Page last updated: August 23, 2015

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