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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014