Back to resultsAurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Primary Purpose
Staphylococcus Aureus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aurexis® (tefibazumab)
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcus Aureus focused on measuring Cystic Fibrosis, Staphylococcus aureus, lungs
Eligibility Criteria
Inclusion Criteria: Male or female, ages > 7 years old Diagnosis of CF as evidenced by sweat chloride test and/or genetic mutation testing Sputum SA CFUs > 10,000 per mL Ability to expectorate sputum Ability to tolerate nasal lavage and collection of breath condensate Willing to practice reliable birth control measures during the entire study period, if subject is of childbearing potential Informed consent obtained from subject or legal guardian, and assent if appropriate Exclusion Criteria: Burkholderia cepacia in sputum Subjects who have had changes to their treatment regimen for CF in the past 6 weeks Subjects can be screened 6 weeks after IV antibiotic completion Subjects can be screened 7 days after oral antibiotic completion Received an investigational drug within 30 days of study entry Received any immune globulin or blood product within 30 days of study entry History of hypersensitivity to immune globulin preparations Undergoing any type of dialysis or expected to start dialysis within 30 days Pregnant or nursing females Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations
Sites / Locations
- Emory University
Outcomes
Primary Outcome Measures
To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
To evaluate the pharmacokinetics of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
Secondary Outcome Measures
To evaluate the biologic and clinical effects of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs on:
Changes in bacterial load of SA in sputum as determined by colony counts
Changes in inflammatory mediators in nasal lavage fluid, breath condensate and plasma, including IL-1β, IL-6, IL-8, and TNFα.
Changes in oxidant/antioxidant balance in nasal lavage, breath condensate and plasma including GSH, GSSG, redox potential, cysteine, and cystine
Changes in pulmonary function tests as determined by FVC, FEV1, and FEF25-75%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00198289
Brief Title
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Official Title
A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus.
The purpose of this study is to assess the safety and pharmacokinetic profile (concentration of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus
Keywords
Cystic Fibrosis, Staphylococcus aureus, lungs
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aurexis® (tefibazumab)
Primary Outcome Measure Information:
Title
To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
Title
To evaluate the pharmacokinetics of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
Secondary Outcome Measure Information:
Title
To evaluate the biologic and clinical effects of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs on:
Title
Changes in bacterial load of SA in sputum as determined by colony counts
Title
Changes in inflammatory mediators in nasal lavage fluid, breath condensate and plasma, including IL-1β, IL-6, IL-8, and TNFα.
Title
Changes in oxidant/antioxidant balance in nasal lavage, breath condensate and plasma including GSH, GSSG, redox potential, cysteine, and cystine
Title
Changes in pulmonary function tests as determined by FVC, FEV1, and FEF25-75%
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, ages > 7 years old
Diagnosis of CF as evidenced by sweat chloride test and/or genetic mutation testing
Sputum SA CFUs > 10,000 per mL
Ability to expectorate sputum
Ability to tolerate nasal lavage and collection of breath condensate
Willing to practice reliable birth control measures during the entire study period, if subject is of childbearing potential
Informed consent obtained from subject or legal guardian, and assent if appropriate
Exclusion Criteria:
Burkholderia cepacia in sputum
Subjects who have had changes to their treatment regimen for CF in the past 6 weeks
Subjects can be screened 6 weeks after IV antibiotic completion
Subjects can be screened 7 days after oral antibiotic completion
Received an investigational drug within 30 days of study entry
Received any immune globulin or blood product within 30 days of study entry
History of hypersensitivity to immune globulin preparations
Undergoing any type of dialysis or expected to start dialysis within 30 days
Pregnant or nursing females
Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Hetherington, M.D.
Organizational Affiliation
Inhibitex
Official's Role
Study Director
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
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