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

Staphylococcus Aureus Bacteremia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198302
• Other study ID #: INH-AUR-002
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: March 28, 2013
• Est. completion date: February 2005

Study information

• Verified date: March 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Bacteremia
• Staphylococcus Aureus Bacteremia

Intervention

Drug:
• Aurexis®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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
Primary	• To evaluate the pharmacokinetics of a single dose of Aurexis® in combination with standard of care in the subjects with SAB
Primary	• To evaluate the activity of a single dose of Aurexis® in combination with standard of care, as measured by:
Primary	o number of subjects with uncomplicated SAB at baseline who progress to complicated SAB
Primary	o number of subjects with microbiologically documented relapse of SAB
Primary	o mortality rates
Secondary	• To evaluate the effect of a single dose of Aurexis® in combination with standard of care on the:
Secondary	o proportion of subjects who develop sepsis, severe sepsis, or septic shock
Secondary	o time to achieve a negative blood culture
Secondary	o time to defervescence
Secondary	o mean (and median) number of days in the hospital and ICU
Secondary	o mean (and median) number of days requiring mechanical ventilation