DefenCath for Central Line Bloodstream Infection

Recruiting at 14 trial locations

Overseen By Liz Hurlburt, Chief Clinical Strategy & Operations Officer

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: CorMedix

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

Disqualifiers: Unstable arrhythmia, Bleeding diathesis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DefenCath, which aims to prevent infections in individuals receiving nutrition through a central line (a long-term intravenous catheter). The trial compares DefenCath with the standard treatment, heparin (an anticoagulant), to determine which is more effective and safe. Participants should be adults who rely on home intravenous nutrition several days a week and have had their central line in place for at least a week. The goal is to find a better way to reduce the risk of bloodstream infections for those requiring long-term parenteral nutrition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 have taken systemic antibiotics in the last 14 days or if you are using medications that interact with citrate, taurolidine, or heparin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DefenCath is generally safe for adults. One study found that DefenCath reduced the risk of catheter-related bloodstream infections by 71% compared to heparin, a common treatment. Although the FDA has approved DefenCath for reducing these infections, no safety information exists for its use in children. This indicates that while the treatment is well-tolerated in adults, unknowns may exist for other groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

DefenCath is unique because it combines two powerful antimicrobials, catheter lock solution, and an anticoagulant to prevent central line bloodstream infections. Unlike standard treatments that mainly focus on anticoagulation, DefenCath targets bacterial and fungal growth directly within the catheter, which is the source of many infections. Researchers are excited about DefenCath because its dual action not only fights infection but also helps maintain catheter patency, potentially reducing hospital stays and improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for central line bloodstream infection?

Previous studies have shown that DefenCath reduces infections effectively. Participants in this trial may receive DefenCath, which lowers the risk of catheter-related bloodstream infections (CRBSIs) by 71% compared to the standard treatment with heparin used in the control arm. This results in fewer infections for those using DefenCath. It is the first FDA-approved solution for catheters proven to reduce these infections. This evidence suggests DefenCath could be an effective option for preventing infections in people using central venous catheters. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Adults over 18 in the US who need long-term nutrition through a central line and have had at least one infection from it in the past year. They must be stable, able to use or learn to use the treatment, and agree to daily diary keeping.

Inclusion Criteria

I have signed and provided informed consent.

I have been clinically stable for at least 4 weeks.

I have a permanent CVC or PICC line that's been in place for over a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DefenCath or heparin as a Catheter Lock Solution (CLS) while receiving Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC)

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• DefenCath
• Heparin

Trial Overview The study is testing DEFENCATH®, a catheter lock solution, against heparin in preventing infections for those getting nutrition directly into their veins at home. It's randomized and double-blind, meaning neither participants nor researchers know who gets which treatment.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06822426

Study Details | NCT06822426 | Comparing The Safety And ... The proportion of participants who remain infection-free in the treatment groups will be compared, censoring participants who do not experience a CLABSI within ...

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. uclahealth.org uclahealth.org/clinical-trials/comparing-safety-and-efficacy-defencathr-reducing-central

Comparing The Safety And Efficacy Of DEFENCATH® In ... Clinical Trials. Open Actively Recruiting. Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults ...

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

214520Orig1s000 - accessdata.fda.gov In this study, although there was a higher number of gram-positive infections in the both groups, the infection frequency for gram-negative ...

5. defencath.com defencath.com/

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

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/214520s003lbl.pdf

214520s003lbl.pdf - accessdata.fda.gov The safety and effectiveness of DEFENCATH have not been established in pediatric patients. There are no available data on DEFENCATH use in pediatric patients.

7. defencathresources.com defencathresources.com/wp-content/uploads/2025/01/COR24-008_Product-Fact-Sheet-DIGITAL_Submitted_011324.pdf

Protect the central line INDICATIONS AND USAGE. LIMITED POPULATION: DefenCath® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI).