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Aurexis® 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
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcus Aureus focused on measuring Cystic Fibrosis, Staphylococcus aureus, lungs

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 9, 2005
Last Updated
March 28, 2013
Sponsor
Bristol-Myers Squibb
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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

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Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs

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