Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229008
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2005-09-27
Brief Title:
Ceftobiprole in Hospital Acquired Pneumonia
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
Status:
COMPLETED
Status Verified Date:
2012-08
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 the water-soluble prodrug form of ceftobiprole referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia
Detailed Description:
Ceftobiprole medocaril the water-soluble prodrug form of ceftobiprole referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA Methicillin-Resistant Staphylococcus Aureus activity Ceftobiprole is not yet approved for the treatment of nosocomial hospital-acquired pneumonia This is a randomized double-blind multicenter study of ceftobiprole versus a comparator linezolid plus ceftazidime to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia The patients will be randomized to ceftobiprole plus placebo or the comparator The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days unless extended at discretion of medical monitor Patient safety will be monitored throughout the study In December 2006 this study BAP00248 and another similar study BAP00307 see NCT00210964 were amended changed to create 1 study BAP00248307Therefore the results reported for this study will be combined with the results reported for study BAP00248 Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion 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 |
|---|---|---|---|
| BAP00248 | None | None | None |