Taurolidine + Heparin for Catheter-Associated Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a catheter lock solution called DefenCath, which combines taurolidine and heparin, to determine its effectiveness in preventing catheter-related bloodstream infections in young patients undergoing regular kidney dialysis. The study targets children under 18 with kidney failure who receive dialysis at least twice a week using a central venous catheter. Participants should not have had recent infections or certain medical conditions, such as severe heart issues. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for a broader patient population.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking medications that interact with taurolidine, citrate, or heparin, or if you have taken systemic antibiotics in the last 14 days.
What is the safety track record for Taurolidine and Heparin Catheter Lock Solution?
Previous studies have shown that DefenCath, a solution combining taurolidine and heparin to keep catheters clear, has promising safety results. Serious side effects occurred in 40% of patients using DefenCath, compared to 42% of those using only heparin, suggesting that DefenCath is as safe as the well-known treatment heparin.
The FDA has already approved DefenCath for reducing catheter-related bloodstream infections (CRBSIs) in adults. This approval indicates thorough safety checks for adults, although the current trial specifically examines its use in children.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about DefenCath® because it combines taurolidine and heparin to combat catheter-associated infections in a novel way. Unlike standard treatments that primarily rely on antibiotics to address infections, taurolidine acts as an antimicrobial agent with broad-spectrum activity, reducing the risk of antibiotic resistance. Additionally, the inclusion of heparin helps maintain catheter patency, addressing two issues simultaneously. This dual-action approach not only targets infection but also helps keep the catheter functioning properly, making it a promising alternative to conventional treatments.
What is the effectiveness track record for Taurolidine and Heparin Catheter Lock Solution in preventing catheter-associated infections?
Research has shown that the Taurolidine and Heparin Catheter Lock Solution, known as DefenCath, effectively reduces catheter-related bloodstream infections. In this trial, participants will receive either DefenCath or a control treatment. Studies have demonstrated that DefenCath can lower the risk of these infections by 71% compared to heparin alone. One study found that a solution containing taurolidine reduced the rate of repeat infections by 68% in adults. This combination prevents bacteria from adhering to the catheter, helping to keep the bloodstream infection-free. DefenCath has proven effective and is already approved for use.46789
Are You a Good Fit for This Trial?
This trial is for children and adolescents (birth to <18 years) with kidney failure who are on chronic hemodialysis using a central venous catheter. They must be expected to need the catheter for at least 60 days, have guardians able to comply with study requirements, and not be likely to pass away within 180 days.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DefenCath or institutional standard of care to assess safety and time to CRBSI
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Taurolidine and Heparin Catheter Lock Solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
CorMedix
Lead Sponsor