Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia
February 19, 2013 updated by: Basilea Pharmaceutica
Randomized, Open-Label Study Evaluating the Safety and Rate of Bacterial Clearance of Ceftobiprole 500 Milligram Every 8 Hours Compared to Conventional Therapy in the Treatment of Hospitalized Subjects With Staphylococcus Aureus Bacteremia
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.
Study Overview
Detailed Description
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus aureus) activity.
Ceftobiprole medocaril in not approved for the treatment of bacterial blood stream infections.
S. aureus is a major human pathogen.
It causes a wide range of serious infections, including skin and skin structure infections, infections of vascular devices and catheters, and infections of the heart and lungs, bones and joints, and deep tissues.
Particularly challenging and difficult to treat are blood-borne infections (bacteremia).
Bacteremic infections are prone to relapse and they are often complicated by metastatic seeding of sites throughout the body.
MRSA strains are increasing in prevalence, incidence, and virulence.
Moreover, the frequency of patients presenting with persistent MRSA bacteremia appears to be rising.
The objective of the open label trial is to compare the effectiveness and safety of ceftobiprole versus a comparator in patients with MRSA and MSSA (methicillin-susceptible Staphylococcus aureus) in bacteremic patients.
Patients who meet inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to either ceftobiprole or comparator.
The primary end point is time to bloodstream clearance of MRSA and MSSA in patients.
Patients will be randomized to either ceftobiprole or comparator for 7 days.
Study Type
Interventional
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hospitalized patients with signs and symptoms suggestive of systemic staphylococcal infection as defined in the protocol
- Female patients must be postmenopausal (for at least 1 year), surgically sterile or practicing an effective method of birth control, male partner sterilization or, at the discretion of the investigator, abstinence, before entry and throughout the study and have a negative urine pregnancy test (confirmed with a negative serum pregnancy test) at screening.
Exclusion Criteria:
- Female patients who are pregnant or lactating
- Known or suspected hypersensitivity to beta-lactam antibiotics or any other study medications
- Receipt of vancomycin or other antistaphylococcal drug for > 2 calendar days prior to initiation of study drug
- Diagnosis of a catheter-related GPC-cl bacteremia at the time of study enrollment
- Clinical findings of left-sided endocarditis prior to enrollment or any time during study participation
- Requirement for surgery during the seven days of study therapy administration with the exception of surgery required to manage a complication of S. aureus bacteremia
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
To determine the effect of ceftobiprole on the time to bloodstream clearance of methicillin-resistant Staphylococcus aureus and methicillin-susceptible Staphylococcus aureus (MSSA) in treated bacteremic patients.
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
To determine the effect of ceftobiprole versus comparator on the time to bloodstream clearance of MRSA and MSSA, respectively and bloodstream clearance of MRSA compared to MSSA in bacteremic patients.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
April 1, 2009
Study Registration Dates
First Submitted
July 19, 2007
First Submitted That Met QC Criteria
July 19, 2007
First Posted (Estimate)
July 23, 2007
Study Record Updates
Last Update Posted (Estimate)
February 20, 2013
Last Update Submitted That Met QC Criteria
February 19, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR013807
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.