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Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00027248
Recruitment Status : Completed
First Posted : November 30, 2001
Last Update Posted : September 14, 2005
Sponsor:
Information provided by:
BioWest Therapeutics Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sepsis Bacteremia Fungemia Drug: MBI 226 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : September 2000
Study Completion Date : July 2003
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Reduction of catheter-related bloodstream infection

Secondary Outcome Measures :
  1. Reduction of catheter colonization
  2. Reduction of local catheter site infection

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027248


Locations
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United States, Illinois
Omnicare Clinical Research Inc.
Lake Bluff, Illinois, United States, 60044
Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
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Study Director: Jim Pankovich BioWest Therapeutics Inc
More Information
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ClinicalTrials.gov Identifier: NCT00027248    
Other Study ID Numbers: 226-98-002
First Posted: November 30, 2001    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005
Keywords provided by BioWest Therapeutics Inc:
central venous catheter
bloodstream infection
CVC
catheter colonization
local catheter site infection
Additional relevant MeSH terms:
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Bacteremia
Fungemia
Infection
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Invasive Fungal Infections
Mycoses
Omiganan pentahydrochloride
Anti-Infective Agents