Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326287
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2006-05-12
Brief Title:
Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia
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 ratio of clinically cured patients to the total number of patients of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia
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 community-acquired pneumonia 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 community-acquired pneumonia The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator Patients who meet specified criteria may be switched to an alternative oral treatment The primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit The patients will receive either ceftobiprole medocaril plus placebo or a comparator
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 |
|---|---|---|---|
| 30982081-CAP-3001 | OTHER | Basilea Pharmaceutica International Ltd | None |