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

Staphylococcus Aureus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198289
• Other study ID #: INH-AUR-004
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: March 28, 2013
• Start date: April 2005
• Est. completion date: June 2006

Study information

• Verified date: March 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cystic Fibrosis
• Staphylococcus Aureus

Intervention

Drug:
• Aurexis® (tefibazumab)

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
Primary	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	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:
Secondary	Changes in bacterial load of SA in sputum as determined by colony counts
Secondary	Changes in inflammatory mediators in nasal lavage fluid, breath condensate and plasma, including IL-1ß, IL-6, IL-8, and TNFa.
Secondary	Changes in oxidant/antioxidant balance in nasal lavage, breath condensate and plasma including GSH, GSSG, redox potential, cysteine, and cystine
Secondary	Changes in pulmonary function tests as determined by FVC, FEV1, and FEF25-75%