Sepsis Clinical Trial
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 Arterial and/or Central Venous Catheterization
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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