Status:
COMPLETED
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Staphylococcus Aureus
Eligibility:
All Genders
7+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00198289
Start Date
April 1 2005
End Date
June 1 2006
Last Update
March 29 2013
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322