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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01319253

Enrollment

Registered

2011-03-21

Start date

2011-03-31

Completion date

2015-10-31

Last updated

2015-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Pseudomonas Aeruginosa

Keywords

Cystic Fibrosis, Pseudomonas aeruginosa

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results