Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419991
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2007-01-08
Brief Title:
Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection
Sponsor:
CPL Associates
Organization:
CPL Associates
Study Overview
Official Title:
An Open-Label Noncomparative Multicenter Clinical Trail Measuring Time Related Clinical Response Factors in Relation to Time to Bacterial Eradication With Tigecycline Treatment in Patients With Catheter Infection
Status:
COMPLETED
Status Verified Date:
2011-06
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:
Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms and provides activity against emerging multi-drug resistant pathogens The purpose of this protocol is to determine the linkage between time related clinical measures of infection response and time to bacterial eradication in patients with intravascular catheter infections caused by Staphylococcus epidermidis and other coagulase negative staphylococci
Detailed Description:
Tigecycline a glycylcycline antibiotic and an analog of the tetracycline minocycline demonstrates a broad spectrum of antibacterial activity by inhibiting multiply resistant gram-positive gram-negative anaerobic and atypical bacteria It is being developed as an agent that overcomes tetracycline-resistance mechanisms and provides activity against emerging multi-drug resistant pathogens These attributes may provide clinicians with a valuable therapeutic alternative The purpose of this protocol is to determine the linkage between time related clinical measures of infection response and time to bacterial eradication in patients with intravascular catheter infections caused by Staphylococcus epidermidis and other coagulase negative staphylococci The study is being conducted in two phases The first treats patients who have removal of the catheter at the time of treatment and the second treats patients who have the catheter remaining in situ during tigecycline 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