Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210899
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2005-09-13
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:
False
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 The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in 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 patients can be treated as in-patient out-patient or through a home agency at the discretion of the investigator 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 |
|---|---|---|---|
| BAP00414 | OTHER | Basilea Pharmaceutica Ltd | None |