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

Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT01319253
Collaborator
Gilead Sciences (Industry)
27
Enrollment
1
Location
55
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    27 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics
    Study Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Jul 1, 2012
    Actual Study Completion Date :
    Oct 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Cayston Only Cohort

    This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month.
    Tobi Only Cohort

    This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month.
    Cayston and Tobi Cohort

    This Cohort will be on a previously established medication regiment that includes Cayston and Tobi inhaled antibiotic alternating every other month

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University
    • Gilead Sciences

    Investigators

    • Principal Investigator: Michelle S Howenstine, MD, Indiana University
    • Principal Investigator: Gregory Anderson, PhD, Indiana University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michelle Howenstine, Professor of Clinical Pediatrics, Indiana University
    ClinicalTrials.gov Identifier:
    NCT01319253
    Other Study ID Numbers:
    • HOWEN-ANDER-001
    First Posted:
    Mar 21, 2011
    Last Update Posted:
    Nov 6, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Michelle Howenstine, Professor of Clinical Pediatrics, Indiana University
    Cystic Fibrosis
    Pseudomonas aeruginosa
    Additional relevant MeSH terms:
    Pseudomonas Infections
    Cystic Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Nov 6, 2015