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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00198289
First received: September 9, 2005
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Staphylococcus Aureus
 Drug: Aurexis® (tefibazumab)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

Estimated Enrollment: 30
Study Start Date: April 2005
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
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 and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198289

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Seth Hetherington, M.D. Inhibitex
  More Information

Additional Information:
Click here for more information on this study  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00198289     History of Changes
Other Study ID Numbers: INH-AUR-004
Study First Received: September 9, 2005
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Cystic Fibrosis
Staphylococcus aureus
lungs

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Staphylococcal Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013