Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102947
Status:
TERMINATED
Last Update Posted:
2016-07-25
First Post:
2005-02-04
Brief Title:
Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
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:
An Open Label Phase 4 Trial to Further Evaluate the Pharmacokinetic Profile of Intravenous Daptomycin and a Comparison of the Safety and Efficacy of Daptomycin Versus Comparator in the Treatment of Adult Patients With Renal Impairment and Complicated Skin and Skin Structure Infections Due at Least in Part to Gram-positive Bacteria
Status:
TERMINATED
Status Verified Date:
2016-07
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:
This is a Phase 4 randomized open-label multicenter comparative study designed to further evaluate the pharmacokinetics of intravenous iv daptomycin and the safety and efficacy of daptomycin relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment
Detailed Description:
None
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-REN-03-06 | OTHER | Cubist Study Number | None |