Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)

Recruiting now · Phase 3

Conditions studied: Central Line Associated Blood Stream Infections (CLABSI)

In brief

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.

Key facts

Study ID

NCT06822426

Run by

CorMedix Therapeutics

People needed

200

Starts

2025-05-14

Expected to finish

2028-01-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any participant unable or not willing to sign inform consent.
• Any participant who has received systemic antibiotic within the last 14 days. Topical antibiotics are permitted. Use of metronidazole or rifaximin for treating small intestinal bacterial overgrowth (SIBO) is also permitted.
• Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.
• Any participant with temporary, non-tunneled CVC or temporary PICC.
• Any participant that has received thrombolytic treatment (e.g., tissue-type plasminogen activator [tPA]-Cathflo), not as a part of the institution's standard of care for patency management, in current catheter within 30 days of randomization.
• Any participant with unstable arrhythmia, defined as presence of hemodynamic instability within a month prior to the baseline assessment.
• Any participant using any type of antimicrobial-coated or heparin-coated catheter.
• Any participant with documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization.
• Any participant with a congenitally lethal condition or a life expectancy of less than 6 months.
• Any participant with documented history of an atrial thrombus or known hypercoagulable state.
• Any participant with an open, non-healing skin ulcer.
• Any participant who has received a bone marrow transplant (allogeneic or autogenic/autologous) within the last year.
• Any participant with neutropenia with an absolute neutrophil count <1000 cells/μL
• Any participant with current requirement for systemic immunosuppression that would increase risk of infection including, but not limited to:
• Steroid use at an equivalent dose of prednisone 20 mg/day anticipated or actual for at least 8 weeks.
• Systemic chemotherapy.
• Methotrexate dose sufficiently high to suppress white blood cell count (WBC) count below 5,000 cells/μL.
• Azathioprine dose greater than 2.5 mg/kg/day.
• Calcineurin inhibitors:
• i. Cyclosporine dose greater than 8 mg/kg. ii. Tacrolimus dose greater than 0.4 mg/kg. f. Sirolimus dose greater 10 mg/daily.
• Any participant with known allergies or absolute contraindications to citrate, taurolidine, or heparin or a history of heparin-induced thrombocytopenia.
• Any participant taking other medication with known systemic drug interaction with citrate, taurolidine or heparin.
• Any participant anticipating receiving a transplant within 90 days. Participants can be on a transplant list but a participant with a known or anticipated transplant date within 90 days of study entry should be excluded from study participation. A participant who may receive a transplant >90 days of study entry may remain on the study as long as they continue to receive TPN.
• Any participant who is pregnant or lactating.
• Any participant receiving continuous TPN (infusion over 24 hours).

Where it is running

• University of California Los Angeles — Los Angeles, California, United States (enrolling)
• MedStar Health Research Institute — Washington D.C., District of Columbia, United States (enrolling)
• Bioresearch Partner — Doral, Florida, United States (enrolling)
• Emory University Hospital - GCRC — Atlanta, Georgia, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
• Johns Hopkins Clinical Research Unit — Baltimore, Maryland, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Mount Sinai Medical Center — New York, New York, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Istanbul University Faculty of Medicine, Capa State Hospital — Istanbul, Istanbul, Turkey (Türkiye) (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
• Vanderbilt Center for Human Nutrition — Nashville, Tennessee, United States (enrolling)
• Alchemi - Sugarland — Sugarland, Texas, United States (enrolling)
• Hacettepe University Hospitals — Altındağ, Ankara, Turkey (Türkiye) (enrolling)
• Ankara University Ibni Sina Research and Application Hospital — Çankaya, Ankara, Turkey (Türkiye) (enrolling)
• Ankara Bilkent City Hospital — Çankaya, Ankara, Turkey (Türkiye) (enrolling)
• Hacettepe University Hospitals — Yenimahalle, Ankara, Turkey (Türkiye) (enrolling)
• Duke University Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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