Professional medical feedback suggests that there is an important need to develop an
alternative to the standard of care for catheter-related bloodstream infections (CRBSIs). Of the
approximately 7 million CVCs used annually in the US, up to 500,000 become infected and lead
to CRBSIs. Currently, removing and replacing infected CVCs is the standard of care for most
CRBSIs/CLABSIs. CVC removal and replacement procedures are costly and cause
considerable discomfort. Each CRBSI/CLABSI episode can cost $46,000 - $65,000 and up
to $10,000 for the removal and replacement of the catheter. Approximately 15-20% of
procedures are associated with significant morbidity and up to 67% of patients report adverse
physical and psychological symptoms from the removal and replacement procedure. There are
currently no approved therapies to salvage infected CVCs. The market potential for an effective
antibiotic lock therapy (ALT) is estimated to reach $1.8 billion globally by 2028.
Who is at Risk for Catheter-Related Bloodstream Infections (CRBSIs)?
Certain patient populations are at particularly high risk for complications resulting from CRBSIs, including:
-
Cancer and hemodialysis patients with long-term surgically implantable silicone
catheters. Removal of the CVC and reinsertion of a new one at a different site may be
difficult, or even impossible, because of the unavailability of other accessible vascular
sites and the need to maintain infusion therapy.
-
Critically ill patients with short-term catheters who have underlying coagulopathy, where
the blood’s ability to clot is impaired. This condition makes reinsertion of a new CVC at a
different site risky in terms of mechanical complications, such as hemopneumothorax,
misplacement, or arterial puncture.
Catheter-Related Bloodstream Infections (CRBSIs)
Central venous catheters (CVCs) are life-saving vascular access ports in patients requiring long-term intravenous therapy. CVCs are used to administer fluids, blood products, nutritional solutions, and medication, as well as for hemodynamic monitoring.
While CVCs are important in treating many conditions, particularly in intensive care units, they pose a significant risk for device-related infections, and are a leading cause of morbidity and mortality.
Clinical Definition
CRBSI is a clinical term used to categorize patients with an intravascular catheter who have:
-
A bacterial or fungal infection, with at least one positive blood culture obtained from a peripheral vein;
-
Clinical manifestations of infection, including fever, chills, and/or low blood pressure; and
-
No apparent source for the bloodstream infection other than the catheter.
The incidence of CRBSI varies by type of catheter, the frequency of catheter manipulation, and the patient’s underlying disease and severity of illness.
CRBSIs and Biofilm Formation
Colonization of a CVC, by microbes on a patient’s skin and from other external sources, occurs rapidly following device insertion. Biofilm may form when bacteria adhere to surfaces in moist environments by excreting a matrix of glue-like substances. A biofilm community can be formed by a single bacterial species, but more commonly consists of many species of bacteria and other microorganisms.
When a biofilm forms on a catheter surface, it may put patients at a higher risk of developing recurrent CRBSIs, and may also make CRBSIs more resistant to conventional treatment.
Managing CRBSIs
The standard of care in the management of CRBSIs consists of removing the infected CVC and replacing it with a new catheter at a different vascular access site. These procedures are costly, and 15% to 20% of the procedures are associated with significant morbidity. There are currently no approved therapies to salvage infected CVCs.