Back to resultsSafety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections
Primary Purpose
Sepsis, Bacteremia, Fungemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MBI 226
Sponsored by
About this trial
This is an interventional prevention trial for Sepsis focused on measuring central venous catheter, bloodstream infection, CVC, catheter colonization, local catheter site infection
Eligibility Criteria
Inclusion Criteria: Patients undergoing non-cuffed arterial and/or central venous catheterization. Patients able to give signed informed consent. Concurrent antibiotic therapy is permitted. Exclusion Criteria: Treatment with an experimental topical, antibacterial, or antifungal drug within the previous 30 days. Patients who are scheduled to receive catheters impregnated/bonded with an antimicrobial substance. Patients requiring arterial or central venous catheterization for less than 48 hours or longer than 28 days. Second or third degree burn patients. Patients with a suspected or known bloodstream infection or local catheter insertion site infection. Patients with a known allergy to adhesive tape or adhesive bandages. Patients with a medical condition that the Investigator believes may interfere with the safety of the patient or the intent or conduct of the study. Routine non-complicated post-operative CABG patients. The disinfection procedure for catheter insertion did not include povidone-iodine.
Sites / Locations
- Omnicare Clinical Research Inc.
Outcomes
Primary Outcome Measures
Reduction of catheter-related bloodstream infection
Secondary Outcome Measures
Reduction of catheter colonization
Reduction of local catheter site infection
Full Information
NCT ID
NCT00027248
First Posted
November 29, 2001
Last Updated
September 12, 2005
Sponsor
BioWest Therapeutics Inc
1. Study Identification
Unique Protocol Identification Number
NCT00027248
Brief Title
Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
BioWest Therapeutics Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Bacteremia, Fungemia
Keywords
central venous catheter, bloodstream infection, CVC, catheter colonization, local catheter site infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
1400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MBI 226
Primary Outcome Measure Information:
Title
Reduction of catheter-related bloodstream infection
Secondary Outcome Measure Information:
Title
Reduction of catheter colonization
Title
Reduction of local catheter site infection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing non-cuffed arterial and/or central venous catheterization.
Patients able to give signed informed consent.
Concurrent antibiotic therapy is permitted.
Exclusion Criteria:
Treatment with an experimental topical, antibacterial, or antifungal drug within the previous 30 days.
Patients who are scheduled to receive catheters impregnated/bonded with an antimicrobial substance.
Patients requiring arterial or central venous catheterization for less than 48 hours or longer than 28 days.
Second or third degree burn patients.
Patients with a suspected or known bloodstream infection or local catheter insertion site infection.
Patients with a known allergy to adhesive tape or adhesive bandages.
Patients with a medical condition that the Investigator believes may interfere with the safety of the patient or the intent or conduct of the study.
Routine non-complicated post-operative CABG patients.
The disinfection procedure for catheter insertion did not include povidone-iodine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Pankovich
Organizational Affiliation
BioWest Therapeutics Inc
Official's Role
Study Director
Facility Information:
Facility Name
Omnicare Clinical Research Inc.
City
Lake Bluff
State/Province
Illinois
ZIP/Postal Code
60044
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections
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