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

Sponsored by:	Inhibitex
Information provided by:	Inhibitex
ClinicalTrials.gov Identifier:	NCT00198302

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 II

MedlinePlus related topics: Antibiotics Sepsis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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)

Further study details as provided by Inhibitex:

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

Inhibitex

Investigators

Study Director:

Seth Hetherington, M.D.

Inhibitex

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	INH-AUR-002
Study First Received:	September 9, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00198302
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inhibitex:

staphylococcus aureus
bacteremia
sepsis

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections

Sepsis
Bacteremia
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009