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Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00198302
First received: September 9, 2005
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

Hospitalized patients at least 18 years of age, with Staphylococcus aureus bacteremia (SAB) 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 pharmacokinetics of standard antibiotic therapy, plus Aurexis or Placebo for treatment of (SAB). Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.


Condition Intervention Phase
Staphylococcus Aureus Bacteremia
 Drug: Aurexis®
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Phase II, Randomized, Double-blind, Multi-center Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • • To evaluate the safety of standard of care, plus a single dose of Aurexis® compared to a single dose of placebo, in subjects with documented SAB
  • • To evaluate the pharmacokinetics of a single dose of Aurexis® in combination with standard of care in the subjects with SAB
  • • To evaluate the activity of a single dose of Aurexis® in combination with standard of care, as measured by:
  • o number of subjects with uncomplicated SAB at baseline who progress to complicated SAB
  • o number of subjects with microbiologically documented relapse of SAB
  • o mortality rates

Secondary Outcome Measures:
  • • To evaluate the effect of a single dose of Aurexis® in combination with standard of care on the:
  • o proportion of subjects who develop sepsis, severe sepsis, or septic shock
  • o time to achieve a negative blood culture
  • o time to defervescence
  • o mean (and median) number of days in the hospital and ICU
  • o mean (and median) number of days requiring mechanical ventilation

Estimated Enrollment: 60
Estimated Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age ≥ 18 years old
  • Informed consent obtained from subject or legal guardian
  • Willing to practice reliable birth control measures during the study period
  • Diagnosis of SAB, as evidenced by clinical symptoms and one positive blood culture obtained ≤ 72 hours prior to initiation of study drug infusion

Exclusion Criteria:

  • Pregnant or nursing females
  • Polymicrobial bacteremia
  • Diagnosis of septic shock (refer to APPENDIX B)
  • Neutropenia (absolute neutrophil count < 500/mm³)
  • Undergoing any type of dialysis or expected to start dialysis within 30 days
  • Moribund clinical condition with a high likelihood of death within 72 hours of randomization
  • Received an investigational drug within 30 days of study entry
  • 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: NCT00198302

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Seth Hetherington, M.D. Inhibitex
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00198302     History of Changes
Other Study ID Numbers: INH-AUR-002
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:
staphylococcus aureus
bacteremia
sepsis

Additional relevant MeSH terms:
Bacteremia
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Gram-Positive Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013