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

N/ACompletedNCT01319253

Indiana University27 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cystic Fibrosis Pseudomonas Aeruginosa

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Every three months within a 12 month period

Secondary Outcomes

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.

Time frame: Every 3 months within a 12 month period