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)

NCT06822426 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NUTRI-GUARD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

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.

Conditions

Central Line Associated Blood Stream Infections (CLABSI)

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (2)

DefenCath®

EXPERIMENTAL

Drug: (taurolidine and heparin) catheter lock solution

Control

ACTIVE COMPARATOR

Drug: Heparin

Interventions

(taurolidine and heparin) catheter lock solution DRUG

for central venous catheter installation use

DefenCath®

Heparin DRUG

Heparin

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• CorMedix: lead

Study Sites (15)

University of California Los Angeles

Los Angeles, California, 90024, United States

RECRUITING

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Bioresearch Partner

Doral, Florida, 33122, United States

RECRUITING

Emory University Hospital - GCRC

Atlanta, Georgia, 30322, United States

RECRUITING

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

Johns Hopkins Clinical Research Unit

Baltimore, Maryland, 21205, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3285, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27710, United States

ACTIVE NOT RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Vanderbilt Center for Human Nutrition

Nashville, Tennessee, 37212-1150, United States

RECRUITING

Alchemi - Sugarland

Sugar Land, Texas, 77478, United States

RECRUITING

MeSH Terms

Interventions

taurolidine; Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Liz Hurlburt, Chief Clinical Strategy & Operations Officer

CONTACT

908-517-9500; lhurlburt@cormedix.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 12, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Pending FDA Approval

Locations

US (15)