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

September 12, 2005 updated by: BioWest Therapeutics Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Lake Bluff, Illinois, United States, 60044
        • Omnicare Clinical Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of catheter-related bloodstream infection

Secondary Outcome Measures

Outcome Measure
Reduction of catheter colonization
Reduction of local catheter site infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioWest Therapeutics Inc

Investigators

  • Study Director: Jim Pankovich, BioWest Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

November 29, 2001

First Submitted That Met QC Criteria

November 29, 2001

First Posted (Estimate)

November 30, 2001

Study Record Updates

Last Update Posted (Estimate)

September 14, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 226-98-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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