DefenCath for Central Line Bloodstream Infection

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

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 3, randomized, double-blind, controlled, adaptive, 2-arm, multicenter study to demonstrate the efficacy and safety of DefenCath in adult participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.

Eligibility Criteria

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

I have been clinically stable for at least 4 weeks.

Timeline

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

Treatment Details

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.

Participant Groups

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+