A Phase 3 interventional study of MBI 226 in Sepsis, Bacteremia and Fungemia, sponsored by BioWest Therapeutics Inc. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2005-09-14.
Sponsored by BioWest Therapeutics Inc · Phase 3, Interventional, and Prevention
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 1,400 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →BioWest Therapeutics Inc is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reduction of catheter-related bloodstream infection
Reduction of catheter colonization
Reduction of local catheter site infection
This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omiganan pentahydrochloride
BioWest Therapeutics Inc