The federal agency is working with a company on the possible expanded label for a novel solution to prevent central line associated blood stream infections.
Image credit: FDA
The FDA provided feedback to CorMedix in regards to the company’s catheter solution, DefenCath, for the expanded indication of the prevention of central line associated blood stream infections (CLABSI) in adult patients receiving total parenteral nutrition (TPN).1 This patient population is vulnerable to these infections, which can be challenging to treat and can lead to death.
“Given the high rate of CLABSI in patients receiving TPN, we have seen significant inbound interest for study participation by clinical investigators,” CorMedix CEO Joseph Todisco, said in a statement.1
DefenCath is an antimicrobial catheter lock solution (CLS) comprised of the anticoagulant heparin and taurolidine, a broad-spectrum non-antibiotic antimicrobial and antifungal agent. DefenCath is designed to occupy the catheter lumen in between sessions of dialysis.2
The product is the first and only FDA-approved antimicrobial catheter lock solution in the United States. It was approved by the federal agency last November to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath is designed to occupy the catheter lumen in between sessions of dialysis.2
Incidence and Mortality Rates
CLABSI occur in an estimated 250,000 to 500,000 patients annually in the US, have a 10-30% mortality rate, and burden the health care system with an additional $300 million to $2.3 billion a year.3
During the pandemic, these healthcare-associated infections saw a significant increase, especially in patients hospitalized for COVID-19. Data collected from January 1, 2019-March 31, 2022, saw the incidence rate of CLABSI increase to almost 4 times higher among the COVID-19 patients. The most significant increase in HAI incidence occurred in quarter 3 of 2020, with CLABSI incidence per patient days 11.0 (versus 7.3 in Q3 of 2019). 4
Learn more: Differences in Central Line Associated Bloodstream Infections Prior to and During the Pandemic
Catheter-Related Bloodstream Infections
CRBSIs are common in patients with central venous catheters (CVCs). Approximately 80% of patients starting hemodialysis will have a CVC inserted for vascular access. CRBSI’s can occur in up to a third of HD-CVC patients and over 50% of CRBSIs occur within the first 3 months following CVC insertion. Each year, approximately 250,000 CRBSIs occur in patients with an intravascular device, such as central venous catheters, leading to death in about 1 in 4 patients infected. CRBSIs can lead to more hospital admissions, longer stays, and long-term complications such as cardiovascular events. CRBSIs in hemodialysis are caused by a wide range of pathogens, many of which are antibiotic-resistant. 2
What’s Next
The company expects to submit a complete clinical protocol to FDA in the third quarter with a goal of gaining further alignment and initiating the program by the end of 2024. In addition, the FDA confirmed its requirement that CorMedix conduct a study in pediatric hemodialysis (HD) patients under the Pediatric Research Equity Act (PREA).
“Provided we obtain FDA’s concurrence on the final study protocol in a timely manner, we hope to commence a TPN program before the end of 2024,” Todisco said. 1
