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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00027248 History of Changes
Other Study ID Numbers:	226-98-002
First Posted:	November 30, 2001
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:

Bacteremia; Fungemia; Bacterial Infections; Sepsis; Infection	Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Invasive Fungal Infections; Mycoses