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

March 28, 2013 updated by: Bristol-Myers Squibb

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
• 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

Outcome Measure
• 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Seth Hetherington, M.D., Inhibitex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 28, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INH-AUR-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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