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

Tracking Information

First Received Date ^ICMJE

November 29, 2001

Last Updated Date

September 12, 2005

Start Date ^ICMJE

September 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Reduction of catheter-related bloodstream infection

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00027248 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction of catheter colonization
Reduction of local catheter site infection

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sepsis
Bacteremia
Fungemia

Intervention ^ICMJE

Drug: MBI 226

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1400

Completion Date

July 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00027248

Responsible Party

Study ID Numbers ^ICMJE

226-98-002

Study Sponsor ^ICMJE

MIGENIX Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jim Pankovich

MIGENIX Inc.

Information Provided By

MIGENIX Inc.

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP