Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027248
Status:
COMPLETED
Last Update Posted:
2005-09-14
First Post:
2001-11-29
Brief Title:
Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections
Sponsor:
BioWest Therapeutics Inc
Organization:
BioWest Therapeutics Inc
Study Overview
Official Title:
Phase III Randomized Open-Label Study to Assess the Safety and Efficacy of Topical Administration of MBI 226 10 Gel Versus Standard Medical Care in Patients Undergoing Non-Cuffed Short-Term Arterial andor Central Venous Catheterization
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Central venous catheters CVCs are used in patient care for such purposes as the administration of medication fluids blood products and for functions such as hemodialysis and plasmapheresis However the use of CVCs can cause complications such as life-threatening bloodstream infections BSI
BSIs are caused by organisms from the skins surface tracking down the catheters outer surface The organisms grow on the catheter surface catheter colonization which is followed by seeding into the bloodstream BSIs can be difficult to treat and the mortality rate is as high as 35 in Intensive Care patients with a catheter-related BSI It is estimated that up to 70000 patients in the US die each year from catheter-related BSI
MBI 226 is a new drug that when applied to the skin surrounding the catheter insertion site may prevent organisms on the skin from migrating down the catheter and entering the bloodstream and therefore decrease the incidence of catheter-related BSI in patients with CVCs
BSIs are caused by organisms from the skins surface tracking down the catheters outer surface The organisms grow on the catheter surface catheter colonization which is followed by seeding into the bloodstream BSIs can be difficult to treat and the mortality rate is as high as 35 in Intensive Care patients with a catheter-related BSI It is estimated that up to 70000 patients in the US die each year from catheter-related BSI
MBI 226 is a new drug that when applied to the skin surrounding the catheter insertion site may prevent organisms on the skin from migrating down the catheter and entering the bloodstream and therefore decrease the incidence of catheter-related BSI in patients with CVCs
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