Taurolidine + Heparin for Catheter-Associated Infections

Recruiting at 3 trial locations

Overseen By Liz Hurlburt

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: CorMedix

Must not be taking: Antibiotics, Thrombolytics, Immunosuppressants, others

Disqualifiers: Skin infections, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 13 months

36 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{4 6 7 8 9}

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

My doctor does not believe my life expectancy is less than 6 months.

I, or my legal guardian, have given written consent to participate in the study.

I have someone to help me with my study visits and treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DefenCath or institutional standard of care to assess safety and time to CRBSI

13 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Taurolidine and Heparin Catheter Lock Solution

Trial Overview

The trial tests DefenCath, a (taurolidine and heparin) catheter lock solution against standard care in preventing Catheter-related Bloodstream Infections (CRBSI). It's an open-label study focusing on safety and time until infection occurs in pediatric patients.

How Is the Trial Designed?

Group I: DefenCath® Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

CorMedix

Lead Sponsor

Trials

6

Recruited

1,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37678222/

Taurolidine/Heparin Lock Solution and Catheter ... - PubMed

Conclusions: Taurolidine/heparin reduced the risk of developing a CRBSI in study participants receiving hemodialysis via CVC compared with ...

2.

defencath.com

defencath.com/efficacy

Efficacy | DefenCath Taurolidine and Heparin CLS

DefenCath significantly improves upon the SOC (heparin) by reducing the risk of catheter‐related bloodstream infections (CRBSIs) by 71%.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0261561425001487

Taurolidine lock reduces recurrent catheter-related ...

Our study demonstrates that a 1.35% taurolidine-containing catheter lock solution significantly reduces the rate of recurrent CRBSIs by 68% in adult patients ...

4.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2023/214520Orig1s000MultidisciplineR.pdf

214520Orig1s000 - accessdata.fda.gov

Defencath is a catheter lock solution (CLS) which contains taurolidine (13.5 mg/mL) and heparin (1,000 USP units/mL) as the active ingredients ...

5.

defencathresources.com

defencathresources.com/wp-content/uploads/2024/06/Agarwal-Clinical-Journal-of-the-American-Society-of-Nephrology-11-2023.pdf

Taurolidine/Heparin Lock Solution and Catheter-Related ...

Conclusions Taurolidine/heparin reduced the risk of developing a CRBSI in study participants receiving hemodialysis via CVC compared with heparin with a ...

6.

defencath.com

defencath.com/safety

Safety | DefenCath Taurolidine and Heparin CLS

Serious adverse reactions occurred in 40% (159/398) of patients receiving DefenCath as a CLS and 42% (167/399) of patients receiving heparin as a CLS.

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2023/214520s000lbl.pdf

Defencath - accessdata.fda.gov

DEFENCATH® (taurolidine and heparin) catheter lock solution, for central venous catheter instillation use. Initial U.S. Approval: 2023.

8.

defencath.com

defencath.com/

DefenCath Taurolidine and Heparin CLS | Official Website for ...

The first and only FDA-approved catheter lock solution (CLS) proven to significantly reduce the incidence of catheter-related bloodstream infections (CRBSIs) in ...

9.

lablue.com

lablue.com/-/media/Medical%20Policies/2024/10/10/16/15/00892%2020241014%20taurolidine%20and%20heparin%20CLS%20Defencathaccessible%20pdf.pdf

taurolidine and heparin catheter lock solution (Defencath

Defencath® was approved in November of 2023 to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with ...