Staphylococcus Aureus BacteremiaPhase 2NCT00198302
Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)
A Phase 2 study testing Aurexis® in people with Staphylococcus Aureus Bacteremia, run by Bristol-Myers Squibb.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia
- What is being tested?
- Aurexis®
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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)
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.
- Conditions
- Staphylococcus Aureus Bacteremia
- Being tested
- Aurexis®
- Keywords
- staphylococcus aureus, bacteremia, sepsis
- Medical subject headings
- Staphylococcal Infections, Bacteremia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aurexis®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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 outcomes (6)
• 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Seth Hetherington, M.D., Study director, Inhibitex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198302
- Sponsor's protocol ID
- INH-AUR-002
- Status last verified
- Mar 2013
- First submitted
- 9 Sep 2005
- Last updated
- 29 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00198302
- Acronym / sponsor ID
- INH-AUR-002
- Conditions
- Staphylococcus Aureus Bacteremia
- Keywords
- staphylococcus aureus, bacteremia, sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study completion
- Feb 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aurexis® | Drug | – |
Primary outcome
• 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
6 secondary outcomes
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Hetherington, M.D. study director
Inhibitex
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aurexis® in people with Staphylococcus Aureus Bacteremia, run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.