Status and phase
Conditions
Treatments
About
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.
Sex
Ages
Volunteers
Inclusion criteria
Male or female, ages > 7 years old
Exclusion criteria
Burkholderia cepacia in sputum
Subjects who have had changes to their treatment regimen for CF in the past 6 weeks
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
Primary purpose
Allocation
Interventional model
Masking
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Data sourced from clinicaltrials.gov
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