Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090272
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2004-08-25
Brief Title:
A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication 0826-039
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Prospective Multicenter Double-Blind Randomized Comparative Study to Evaluate the Safety Tolerability and Efficacy of a Single Dose of Ertapenem Sodium MK0826 Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery
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 objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery
Detailed Description:
The duration of treatment is 1 day
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 |
|---|---|---|---|
| 2004_010 | None | None | None |