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

This study has been completed.
Sponsor:
Information provided by:
BioWest Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00027248
First received: November 29, 2001
Last updated: September 12, 2005
Last verified: September 2005
  Purpose

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 Intervention Phase
Sepsis
Bacteremia
Fungemia
Drug: MBI 226
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by BioWest Therapeutics Inc:

Primary Outcome Measures:
  • Reduction of catheter-related bloodstream infection

Secondary Outcome Measures:
  • Reduction of catheter colonization
  • Reduction of local catheter site infection

Estimated Enrollment: 1400
Study Start Date: September 2000
Estimated Study Completion Date: July 2003
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027248

Locations
United States, Illinois
Omnicare Clinical Research Inc.
Lake Bluff, Illinois, United States, 60044
Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
Study Director: Jim Pankovich BioWest Therapeutics Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00027248     History of Changes
Other Study ID Numbers: 226-98-002
Study First Received: November 29, 2001
Last Updated: September 12, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by BioWest Therapeutics Inc:
central venous catheter
bloodstream infection
CVC
catheter colonization
local catheter site infection

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 29, 2014