Clinical Trial: Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase III, Randomized, Open-Label Study to Assess the Safety and Efficacy of Topical Administration of MBI 226 1.0% Gel Versus Standard Medical Care in Patients Undergoing Non-Cuffed, Short-Term Arter
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 skin's surface tracking down the catheter's 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 70,000 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 Summary:
Sponsor: BioWest Therapeutics Inc
Current Primary Outcome: Reduction of catheter-related bloodstream infection
Original Primary Outcome:
Current Secondary Outcome:
- Reduction of catheter colonization
- Reduction of local catheter site infection
Original Secondary Outcome:
Information By: BioWest Therapeutics Inc
Dates:
Date Received: November 29, 2001
Date Started: September 2000
Date Completion: July 2003
Last Updated: September 12, 2005
Last Verified: September 2005
