Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228982
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2005-09-27
Brief Title:
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
A Phase III Randomized Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections
Detailed Description:
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA Methicillin-Resistant Staphylococcus Aureus activity Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections This is a randomized double-blind multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days unless extended at discretion of medical monitor
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BAP00154 | OTHER | Basilea Pharmaceutica International Ltd | None |