Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-01-02 @ 7:25 PM
Study NCT ID:
NCT00505258
Status:
WITHDRAWN
Last Update Posted:
2013-02-20
First Post:
2007-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia
Sponsor:
Basilea Pharmaceutica
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was withdrawn due to lack of an appropriate patient population.
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: