Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: ceftobiprole medocaril

Primary Measures

• 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 Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC

Overall Clinical Trial Officials and Contacts

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Study Director Ortho-McNeil Janssen Scientific Affairs, LLC  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00505258

Study ID Number: CR013807

ClinicalTrials.gov Identifier: NCT00505258

Health Authority: United States: Food and Drug Administration