Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia

• Status: Withdrawn
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basilea Pharmaceutica
• Treatments: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins

Criteria

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