Recruiting
Phase 3

DEFENCATH®

Sponsor:

CorMedix Therapeutics

Code:

NCT06822426

Conditions

Central Line Associated Blood Stream Infections (CLABSI)

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

(taurolidine and heparin) catheter lock solution

Heparin

Study Details

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 and adolescent participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.

Conditions

Central Line Associated Blood Stream Infections (CLABSI)

Study ID

NCT06822426

Start date

May 14, 2025

Status verified date

Sep, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

1. Participants who are resident within study site's country.
2. Participants who are male or female, aged ≥12 years at the time of consent.
3. Participants must sign and provide informed consent. For adolescent participants or participants that require a legal representative, written informed consent will be obtained from the study participant's legal guardian or legal representative and the assent from the participant when applicable. All legal guardians and representatives should be fully informed, and participants should be informed to the fullest extent possible about the study using language and terms they are able to understand.
4. Participants who have a tunneled/non-tunneled CVC or peripherally inserted central catheter (PICC) made of silicone or polyurethane, which has been in place for at least 7 days prior to enrollment.
5. Participants who require long-term (>3 Months) TPN based on the investigator assessments.
6. Participants who require TPN for at least 3 days per week, of which 2 days have to be parenteral nutrition (PN).
7. Participants who have a minimum of a 4-hour CLS dwelling time and are willing to lock all lumens at a minimum of every 7 days.
8. Participants who are clinically stable, in the opinion of the investigator, for at least 4 weeks prior to enrollment.
9. Participants who are able and willing to be trained or have a caregiver who is willing and able to be trained on the instillation, aspiration of DefenCath or heparin, and to maintain a daily diary.

Male or female participants:
10. Women of childbearing potential (WOCBP; see Section 4.5.1) must have a negative pregnancy test at screening (i.e., the participant is not pregnant); not be lactating; and use an acceptable method of contraception including but not limited to, abstinence, bilateral tubal ligation, vasectomized partner, a barrier method (diaphragm or condom), Depo-Provera, intrauterine device, or hormonal contraceptive (oral, implant, ring, patch) for the duration of the program until at least 30 days after the last DefenCath CLS instillation. (NOTE: The participant must have used the chosen method of birth control for at least 1 month/cycle prior to enrollment into the study).
11. Male participants who are sexually active with a female partner of childbearing potential must agree to use male condoms with spermicide, even if the male participant has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last DefenCath CLS instillation.
12. Participants who comply with all study procedures and follow-up evaluations.

Exclusion Criteria:

1. Any participant unable or not willing to sign inform consent or, in the case of adolescents, not willing to provide assent.
2. Any participant who is currently receiving systemic antibiotics. Topical antibiotics are permitted. Use of metronidazole or rifaximin for treating small intestinal bacterial overgrowth (SIBO) is also 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 secondary CVC in addition to the primary TPN line.
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 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 who has received an allogeneic hematopoietic stem cell transplant within the last year.
13. Any participant with neutropenia with an absolute neutrophil count <500 cells/μL
14. Any participant with current requirement for systemic chemotherapy and or immunosuppression and absolute neutrophil count <500 cells/μL that occured in the past 4 weeks.
15. Any participant with known allergies or absolute contraindications to citrate, taurolidine, pork products, or heparin or a history of heparin-induced thrombocytopenia.
16. Any participant taking other medication with known systemic drug interaction with citrate, taurolidine or heparin.
17. Any participant anticipating receiving an intestinal 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 an intestinal transplant >90 days of study entry may remain on the study as long as they continue to receive TPN.
18. Any participant who is pregnant or lactating.
19. Any participant receiving continuous TPN (infusion over 24 hours).
20. 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.
21. Any participants who are participating in another interventional clinical study or planning/anticipating participating in another interventional clinical study, except for non-pharmacological research studies.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: DefenCath®

active comparator: Control

Interventions

(taurolidine and heparin) catheter lock solution

for central venous catheter installation use

Heparin

Heparin

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Liz Hurlburt, Chief Clinical Strategy & Operations Officer

908-517-9500lhurlburt@cormedix.com

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90024

Contacts

MedStar Health Research Institute

Recruiting

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

Contacts

Bioresearch Partner

Recruiting

Doral, Florida, United States, 33122

Contacts

Emory University Hospital - GCRC

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Johns Hopkins Clinical Research Unit

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Sara Keller, MD, MPH, MSHP

410-952-7572Skeller9@jhmi.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-3285

Contacts

David F Mercer, MD, PhD, FRCS(C)

402-559-6955dmercer@unmc.edu

Rachel Harper, RN, BSN

402-559-1282raharper@unmc.edu

Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Contacts

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Cynthia Stokes

stokesc2@ccf.org

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Marion Winkler, PhD, RD, LDN, CNSC

401-444-4276mwinkler@brownhealth.org

Vanderbilt Center for Human Nutrition

Recruiting

Nashville, Tennessee, United States, 37212-1150

Contacts

Alchemi - Sugarland

Recruiting

Sugarland, Texas, United States, 77478

Contacts

More Information

Sponsor

CorMedix Therapeutics

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by CorMedix Therapeutics on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.