History of Changes for Study: NCT00198289

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

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Study Record Versions

Version	Submitted Date	Changes
1	September 12, 2005	None (earliest Version on record)
2	September 6, 2006	Recruitment Status, Study Status, Contacts/Locations and Outcome Measures
3	March 28, 2013	Sponsor/Collaborators, Study Identification and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	INH-AUR-004
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
Secondary IDs:

Study Status


Record Verification:	March 2013
Overall Status:	Completed
Study Start:	April 2005
Primary Completion:
Study Completion:	June 2006

First Submitted:	September 9, 2005
First Submitted that Met QC Criteria:	September 12, 2005
First Posted:	September 20, 2005 [Estimate]

Last Update Submitted that Met QC Criteria:	March 28, 2013
Last Update Posted:	March 29, 2013 [Estimate]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:

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.

Detailed Description:

Conditions


Conditions:	Staphylococcus Aureus
Keywords:	Cystic Fibrosis Staphylococcus aureus lungs

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Phase 2
Interventional Study Model:	Single Group Assignment
Number of Arms:
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	30

Arms and Interventions


Intervention Details:
	Drug: Aurexis® (tefibazumab)

Outcome Measures


Primary Outcome Measures:
1.	To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
2.	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:
1.	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:
2.	Changes in bacterial load of SA in sputum as determined by colony counts
3.	Changes in inflammatory mediators in nasal lavage fluid, breath condensate and plasma, including IL-1β, IL-6, IL-8, and TNFα.
4.	Changes in oxidant/antioxidant balance in nasal lavage, breath condensate and plasma including GSH, GSSG, redox potential, cysteine, and cystine
5.	Changes in pulmonary function tests as determined by FVC, FEV1, and FEF25-75%

Eligibility


Minimum Age:	7 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Study Officials:	Seth Hetherington, M.D. Study Director Inhibitex
Locations:	United States, Georgia
	Emory University Atlanta, Georgia, United States, 30322

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: