Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
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.