DefenCath Approved to Prevent Catheter-Related Bloodstream Infections in Dialysis Patients

The Food and Drug Administration (FDA) has approved DefenCath^® (taurolidine and heparin) catheter lock solution to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). 

DefenCath is a combination of taurolidine, a thiadiazinane antimicrobial, and heparin, an anticoagulant. Taurolidine has been shown to be active against the following microorganisms: Staphylococcus aureus (including methicillin-sensitive Staphylococcus aureus and methicillin-resistant Staphylococcus aureus), Staphylococcus epidermidis, Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Serratia marcescens, Candida albicans, and Candida glabrata. The product is indicated for use only in adult patients with kidney failure receiving chronic hemodialysis through a CVC.

The approval of DefenCath was based on data from a double-blind, active-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT02651428) that enrolled 806 patients with end-stage renal disease undergoing chronic hemodialysis at least 2 times per week. Study participants were randomly assigned to receive either Defencath (n=397) or heparin (n=398) as a catheter lock solution. 

The primary outcome measure was the presence of CRBSI, defined as at least 1 positive blood culture from a peripheral site or bloodline sample, or either the arterial or venous catheter hub, with signs and symptoms of infection and no other apparent source of bloodstream infection. The final assessment was determined by a clinical adjudication committee (CAC).

Results showed that DefenCath reduced the risk of CRBSI by 71% (95% CI, 38-86) compared with heparin (P =.0006). The incidence of CAC-adjudicated CRBSI was 2.3% (n=9) in the DefenCath group (event rate per 1000 catheter-days, 0.13 [95% CI, 0.07-0.26]) and 8% (n=32) in the heparin group (event rate per 1000 catheter-days, 0.46 [95% CI, 0.33-0.66]).

The most frequently reported adverse reactions reported with DefenCath were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia. The prescribing information also includes warnings and precautions related to heparin-induced thrombocytopenia and drug hypersensitivity reactions. 

DefenCath is supplied as a sterile catheter lock solution in single-dose vials in the following strengths: 3mL containing taurolidine 40.5mg/3mL (13.5 mg/mL), and heparin 3000 USP Units/3mL (1000 USP Units/mL); and 5mL containing taurolidine 67.5mg/5mL (13.5mg/mL), and heparin 5000 USP Units/5mL (1000 USP Units/mL). It is intended for instillation into CVCs only and should not be used as a catheter lock flush product. Each single-dose vial is designed for use with a single patient as a single instillation in the CVC.

“As the first FDA-approved antimicrobial catheter lock solution designed to prevent CRBSIs, DefenCath offers health care providers an option to reduce the risk of infections in a patient population already vulnerable due to underlying kidney failure,” said Joseph Todisco, Chief Executive Officer of CorMedix.

The product is expected to be available in the first quarter of 2024 in the inpatient setting.