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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319253
• Other study ID #: HOWEN-ANDER-001
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: November 5, 2015
• Start date: March 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2015
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every three months within a 12 month period	No
Secondary	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.	Every 3 months within a 12 month period	No