Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs - Full Text View

Sponsored by:	Inhibitex
Information provided by:	Inhibitex
ClinicalTrials.gov Identifier:	NCT00198289

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 II

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment
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

Further study details as provided by Inhibitex:

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

Inhibitex

Investigators

Study Director:

Seth Hetherington, M.D.

Inhibitex

More Information

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

Study ID Numbers:	INH-AUR-004
Study First Received:	September 9, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00198289
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inhibitex:

Cystic Fibrosis
Staphylococcus aureus
lungs

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases

Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009