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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00027248
Other study ID # 226-98-002
Secondary ID
Status Completed
Phase Phase 3
First received November 29, 2001
Last updated September 12, 2005
Start date September 2000
Est. completion date July 2003

Study information

Verified date September 2005
Source BioWest Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1400
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
MBI 226


Locations

Country Name City State
United States Omnicare Clinical Research Inc. Lake Bluff Illinois

Sponsors (1)

Lead Sponsor Collaborator
BioWest Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of catheter-related bloodstream infection
Secondary Reduction of catheter colonization
Secondary Reduction of local catheter site infection
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