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)

Phase 3

Recruiting

• Conditions: Central Line Associated Blood Stream Infections (CLABSI)
• Interventions: Drug: (taurolidine and heparin) catheter lock solution; Drug: Heparin

• Registration Number: NCT06822426
• Lead Sponsor: CorMedix

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-12
• Study Start: 2025-05-14
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-15
• Primary Completion: 2027-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Any participant unable or not willing to sign inform consent.

2. Any participant who has received systemic antibiotic within the last 14 days. Topical antibiotics are permitted.

3. Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.

4. Any participant with a temporary, non-tunneled CVC or temporary PICC.

5. 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.

6. Any participant with known unstable arrhythmia, defined as presence of hemodynamic instability within a month prior to the baseline assessment.

7. Any participant using any type of antimicrobial-coated or heparin-coated catheter.

8. Any participant with documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization.

9. Any participant with a congenitally lethal condition or a life expectancy of less than 6 months.

10. Any participant with documented history of an atrial thrombus or known hypercoagulable state.

11. Any participant with an open, non-healing skin ulcer.

12. Any participant with neutropenia with an absolute neutrophil count <1500 cells/uL

13. Any participant with current requirement for systemic immunosuppression that would increase risk of infection, including:

    1. Steroid use at an equivalent dose of prednisone 20 mg/day anticipated or actual for at least 8 weeks.

    2. Systemic chemotherapy

    3. Methotrexate dose sufficiently high to suppress white blood cell count (WBC) below 5,000 cells/ul.

    4. Azathioprine dose greater than 2.5 mg/kg/day

    5. Calcineurin inhibitors

       • i.Cyclosporine dose greater than 8 mg/kg
       • ii.Tacrolimus dose greater than 0.4 mg/kg

    6. Sirolimus dose greater 10 mg/daily

14. Any participant with known allergies or absolute contraindications to citrate, taurolidine, or heparin or a history of heparin-induced thrombocytopenia.

15. Any participant taking other medication with known systemic drug interaction with citrate, taurolidine or heparin.

16. 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.

17. Any participant who is pregnant or lactating.

18. Any participant receiving continuous TPN (infusion over 24 hours).

19. Any participant with any medical conditions that render them unable to, or unlikely to complete the study or would interfere with optimal participation in the study or produce significant risk to participant.

20. Any participants who are participating in another interventional clinical study, except for non-pharmacological research studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DefenCath®	(taurolidine and heparin) catheter lock solution	-
Control	Heparin	-

Primary Outcome Measures

Name	Time	Method
Comparison between treatment groups of proportion of participants who experience a Central Line-Associated Bloodstream Infections (CLABSI) within 12 months of the start of the study	Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)	The proportion of participants who remain infection-free in the treatment groups will be compared, censoring participants who do not experience a CLABSI within 9 months, but fail to complete the 12 month follow-up period of the study.

Secondary Outcome Measures

Name	Time	Method
Incidence of AEs, SAEs, treatment-emergent adverse events (TEAEs)	Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)	Compare the safety profile of DefenCath for use as a Catheter Lock Solution (CLS) in adult participants receiving Total Parenteral Nutrition (TPN) through a Central Venous Catheter (CVC) to the control of heparin CLS
Incidence of changes in laboratory evaluations, vital signs, or physical exam findings	Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)	Compare the safety profile of DefenCath for use as a CLS in adult participants receiving TPN through a CVC to the control of heparin CLS

Trial Locations

Locations (5)

Emory University Hospital - GCRC; 🇺🇸 Atlanta, Georgia, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt Center for Human Nutrition; 🇺🇸 Nashville, Tennessee, United States

University of Iowa Health Care; 🇺🇸 Iowa City, Iowa, United States