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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00027248

Enrollment

1400

Registered

2001-11-30

Start date

2000-09-30

Completion date

2003-07-31

Last updated

2005-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Fungemia, Sepsis

Keywords

central venous catheter, bloodstream infection, CVC, catheter colonization, local catheter site infection

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.

Interventions

DRUGMBI 226

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Reduction of catheter-related bloodstream infection	—

Secondary

Measure	Time frame
Reduction of catheter colonization	—
Reduction of local catheter site infection	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026