Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093067
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2004-09-30
Brief Title:
Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S Aureus
Sponsor:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Open-Label Comparative Study to Assess the Safety and Efficacy of Daptomycin Compared to Conventional Therapy In the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to Staph Aureus
Status:
COMPLETED
Status Verified Date:
2017-02
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 safety and efficacy of daptomycin an antibiotic to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus S aureus
Detailed Description:
Even with prompt treatment Staphylococcus aureus Infective Endocarditis IE continues to be associated with significant morbidity and mortality indicating a need for new therapeutic approaches In vitro daptomycin is rapidly bactericidal with concentration-dependent killing and MIC90 of 05 microgramml for S aureus in clinical studies daptomycin appears to be well tolerated and can be administered once every 24 hours by iv infusion These characteristics suggest it should be clinically and microbiologically effective in the treatment of serious S aureus infections including IE and bacteremia
Comparison standard of care Vancomycin or Semi-synthetic Penicillin with adjunct gentamicin
Comparison standard of care Vancomycin or Semi-synthetic Penicillin with adjunct gentamicin
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 |
|---|---|---|---|
| DAP-IE-01-02 | OTHER | Cubist | None |