SepsisPhase 3NCT00027248
Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections
A Phase 3 study testing MBI 226 in people with Sepsis and Bacteremia, run by BioWest Therapeutics Inc at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis, Bacteremia, Fungemia
- What is being tested?
- MBI 226
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Jul 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing non-cuffed arterial and/or central venous catheterization.
- Patients able to give signed informed consent.
- Concurrent antibiotic therapy is permitted.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Omnicare Clinical Research Inc.
Lake Bluff, Illinois, 60044
About this study
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
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.
- Conditions
- Sepsis, Bacteremia, Fungemia
- Being tested
- MBI 226
- Keywords
- central venous catheter, bloodstream infection, CVC, catheter colonization, local catheter site infection
- Medical subject headings
- Sepsis, Bacteremia, Fungemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBI 226Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of catheter-related bloodstream infection
Secondary outcomes (2)
Reduction of catheter colonization
Reduction of local catheter site infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2001 (estimated)
- Study startSep 2000
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- BioWest Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jim Pankovich, Study director, BioWest Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027248
- Sponsor's protocol ID
- 226-98-002
- Status last verified
- Sep 2005
- First submitted
- 29 Nov 2001
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00027248
- Acronym / sponsor ID
- 226-98-002
- Conditions
- Sepsis, Bacteremia, Fungemia
- Keywords
- central venous catheter, bloodstream infection, CVC, catheter colonization, local catheter site infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- BioWest Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Study completion
- Jul 2003
- First posted
- 30 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing non-cuffed arterial and/or central venous catheterization.
- Patients able to give signed informed consent.
- Concurrent antibiotic therapy is permitted.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBI 226 | Drug | – |
Primary outcome
Reduction of catheter-related bloodstream infection
2 secondary outcomes
Reduction of catheter colonization
Reduction of local catheter site infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Pankovich study director
BioWest Therapeutics Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MBI 226 in people with Sepsis and Bacteremia, run by BioWest Therapeutics Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of catheter-related bloodstream infection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2005.