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)
NCT ID: NCT06822426
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-05-14
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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DefenCath®
(taurolidine and heparin) catheter lock solution
for central venous catheter installation use
Control
Heparin
Heparin
Interventions
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(taurolidine and heparin) catheter lock solution
for central venous catheter installation use
Heparin
Heparin
Eligibility Criteria
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Exclusion Criteria
2. 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.
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 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 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 a bone marrow transplant (allogeneic or autogenic/autologous) within the last year.
13. Any participant with neutropenia with an absolute neutrophil count \<1000 cells/μL
14. Any participant with current requirement for systemic immunosuppression that would increase risk of infection including, but not limited to:
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) count below 5,000 cells/μL.
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. f. Sirolimus dose greater 10 mg/daily.
15. Any participant with known allergies or absolute contraindications to citrate, taurolidine, 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 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.
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, except for non-pharmacological research studies.
18 Years
ALL
No
Sponsors
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CorMedix
INDUSTRY
Responsible Party
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Locations
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University of California Los Angeles
Los Angeles, California, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Emory University Hospital - GCRC
Atlanta, Georgia, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Johns Hopkins Clinical Research Unit
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University Irving Medical Center
New York, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt Center for Human Nutrition
Nashville, Tennessee, United States
Alchemi - Sugarland
Sugarland, Texas, United States
Countries
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Central Contacts
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Liz Hurlburt, Chief Clinical Strategy & Operations Officer
Role: CONTACT
Phone: 908-517-9500
Email: [email protected]
Facility Contacts
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Michael C Garcia, MD
Role: primary
Jeraldine Guzman
Role: backup
Jeffrey Shupp, MD
Role: primary
Alison Ross
Role: backup
Thomas R Ziegler, MD
Role: primary
Xu Wang
Role: backup
Caryn Berkowitz, MD
Role: primary
Ethan Hoover, RN, MNHP
Role: backup
Sara Keller, MD, MPH, MSHP
Role: primary
Marwa El-Ashry, BS
Role: backup
Bradley Salonen, MD
Role: primary
David F Mercer, MD, PhD, FRCS(C)
Role: primary
Rachel Harper, RN, BSN
Role: backup
Michael Owen-Michaane, MD
Role: primary
Brett Gray, ANP, MPH
Role: backup
Paul E Wischmeyer, MD
Role: primary
Mary Motta, BSN, RN
Role: backup
Lindsey A Russell, MD, MSc
Role: primary
Cynthia Stokes
Role: backup
Valerianna Amorosa, MD
Role: primary
Kelly Wall
Role: backup
Benjamin Hall, MD
Role: primary
Marion Winkler, PhD, RD, LDN, CNSC
Role: backup
Dawn Adams, MD
Role: primary
Riley Wingerter
Role: backup
Olumayowa Aderinto, MD
Role: primary
Kenneth Morgan, MSc
Role: backup
Other Identifiers
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NUTRI-GUARD
Identifier Type: -
Identifier Source: org_study_id