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Completed

NCT Number: NCT00198302

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.

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Key information

Conditions

Staphylococcus Aureus Bacteremia Bacteremia Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Staphylococcal Infections Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Aurexis®

Drug

Primary outcomes

  1. • 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

  2. • To evaluate the pharmacokinetics of a single dose of Aurexis® in combination with standard of care in the subjects with SAB

  3. • To evaluate the activity of a single dose of Aurexis® in combination with standard of care, as measured by:

  4. o number of subjects with uncomplicated SAB at baseline who progress to complicated SAB

  5. o number of subjects with microbiologically documented relapse of SAB

  6. o mortality rates

Secondary outcomes

  1. • To evaluate the effect of a single dose of Aurexis® in combination with standard of care on the:

  2. o proportion of subjects who develop sepsis, severe sepsis, or septic shock

  3. o time to achieve a negative blood culture

  4. o time to defervescence

  5. o mean (and median) number of days in the hospital and ICU

  6. o mean (and median) number of days requiring mechanical ventilation

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Important dates

Study completion
2005
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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