Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia

NCT00505258 | Withdrawn Phase 2

• 1 other identifier: CR013807
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.

Conditions

Bacteremia

Keywords

Bacteremia; Bloodstream infection; Staphylococcus aureus; Staphylococcal Infections; MRSA; MSSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

ceftobiprole medocaril DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

MeSH Terms

Conditions

Bacteremia; Sepsis; Staphylococcal Infections

Interventions

ceftobiprole medocaril

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 23, 2007
• Study Completion: April 1, 2009
• Last Updated: February 20, 2013

Record last verified: 2013-02