Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299520
Status:
COMPLETED
Last Update Posted:
2008-04-04
First Post:
2006-03-03
Brief Title:
Phase 3 Safety and Efficacy Study of IV Iclaprim v Linezolid in cSSSI ASSIST-1
Sponsor:
Arpida AG
Organization:
Arpida AG
Study Overview
Official Title:
Phase 3 Randomized Investigator-Blind Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure InfectionsASSIST-1
Status:
COMPLETED
Status Verified Date:
2008-04
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 multi-center investigator-blind comparative Phase 3 study Patients will receive either iclaprim or linezolid for 10 to 14 days Patients will be evaluated daily for the first four days of study treatment and then every other day for up to 14 days of the treatment period at End of Therapy the Test Of Cure visit 7 to 14 days post treatment and a Late Follow-up FU visit 7 to 14 days after the TOC visit
Detailed Description:
Primary Objective
The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure TOC visit 7 to 14 days after the end of treatment
Secondary Objectives
The secondary objectives of this study are to compare iclaprim with linezolid regarding
Clinical efficacy at the end of study medication treatment
Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection cSSSI
Clinical outcome in the microbiologically evaluable ME population
Bacteriologic outcome in the ME population
Bacteriologic eradication rates of Baseline BL pathogens
Clinical outcome in the modified intent-to-treat MITT population
Bacteriologic outcome in the MITT population
Baseline in vitro susceptibility of isolated pathogens in the ME population and
Safety and tolerability of iclaprim treatment
The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure TOC visit 7 to 14 days after the end of treatment
Secondary Objectives
The secondary objectives of this study are to compare iclaprim with linezolid regarding
Clinical efficacy at the end of study medication treatment
Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection cSSSI
Clinical outcome in the microbiologically evaluable ME population
Bacteriologic outcome in the ME population
Bacteriologic eradication rates of Baseline BL pathogens
Clinical outcome in the modified intent-to-treat MITT population
Bacteriologic outcome in the MITT population
Baseline in vitro susceptibility of isolated pathogens in the ME population and
Safety and tolerability of iclaprim treatment
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 |
|---|---|---|---|
| ASSIST-1 | None | None | None |