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Completed

NCT Number: NCT00198289

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

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.

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Key information

Conditions

Staphylococcus Aureus Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Gram-Positive Bacterial Infections Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Respiratory Tract Diseases Staphylococcal Infections

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aurexis® (tefibazumab)

Drug

Primary outcomes

  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 outcomes

  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%

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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