Bacteremia Clinical Trial
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
Verified date | February 2013 |
Source | Basilea Pharmaceutica |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Basilea Pharmaceutica |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
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