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