Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514527
Status:
COMPLETED
Last Update Posted:
2008-08-14
First Post:
2007-08-08
Brief Title:
A Study for Patients With Complicated Skin and Skin Structure Infections
Sponsor:
Targanta Therapeutics Corporation
Organization:
Targanta Therapeutics Corporation
Study Overview
Official Title:
Nuvocid Oritavancin at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections SIMPLIFI
Status:
COMPLETED
Status Verified Date:
2008-08
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:
SIMPLIFI
Brief Summary:
Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections cSSSI have been completed
The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI Data from animals support this theory
SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin First dose on Day one with an option for a second dose on Day five compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days
The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI Data from animals support this theory
SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin First dose on Day one with an option for a second dose on Day five compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days
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