Central Line Associated Blood Stream Infections (CLABSI)Phase 3NCT06822426
Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)
A Phase 3 study testing (taurolidine and heparin) catheter lock solution and Heparin in people with Central Line Associated Blood Stream Infections (CLABSI), run by CorMedix Therapeutics at 24 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Central Line Associated Blood Stream Infections (CLABSI)
- What is being tested?
- (taurolidine and heparin) catheter lock solution and Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 14 May 2025to Jan 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any participant unable or not willing to sign inform consent or, in the case of adolescents, not willing to provide assent.
- 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.
- Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.
- Any participant with a secondary CVC in addition to the primary TPN line.
- 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.
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- 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 an allogeneic hematopoietic stem cell transplant within the last year.
- Any participant with neutropenia with an absolute neutrophil count <500 cells/μL
- 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.
- Any participant with known allergies or absolute contraindications to citrate, taurolidine, pork products, 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 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.
- Any participant who is pregnant or lactating.
- Any participant receiving continuous TPN (infusion over 24 hours).
- 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.
- 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.
Trial locations and contacts
24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Liz Hurlburt, Chief Clinical Strategy & Operations Officer contact
24 sites in 2 countries
United States19 sites, 18 recruiting
- Recruiting
Emory University Hospital - GCRC
Atlanta, Georgia, 30322
Thomas R Ziegler, MD, 404-727-7351, tzieg01@emory.edu
Xu Wang, xwang39@emory.edu
- Recruiting
Johns Hopkins Clinical Research Unit
Baltimore, Maryland, 21205
Sara Keller, MD, MPH, MSHP, 410-952-7572, Skeller9@jhmi.edu
Marwa El-Ashry, BS, 667-306-9370, melashr1@jh.edu
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Carol Semrad, MD, 773-702-6921, csemrad@bsd.uchicago.edu
Kristi Kearney, 773-834-7414, kristi.kearney@uchicagomedicine.org
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Jessica Sosio, DO, 216-442-2416, sosioj@ccf.org
Cynthia Stokes, stokesc2@ccf.org
- Recruiting
Bioresearch Partner
Doral, Florida, 33122
Rafael Abreu, MD, 833-489-4968, rabreumd@bioresearchpartner.com
Keila Hoover, 833-489-4868, khoovermd@bioresearchpartner.com
- Withdrawn
Duke University Hospital
Durham, North Carolina, 27710
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
Divya Ashat, MD, 319-384-5492, divya-ashat@uiowa.edu
Ethan Hoover, RN, MNHP, 319-335-9767, ethan-hoover@uiowa.edu
- Recruiting
University of California Los Angeles
Los Angeles, California, 90024
Michael C Garcia, MD, 310-206-1987, mcgarcia@mednet.ucla.edu
Jeraldine Guzman, 310.206.8292, Jbguzman@mednet.ucla.edu
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Dejan Micic, MD, 888-584-7888, dejan.micic@lumc.edu
Maria Chavez, 464-220-9498, mchavez11@luc.edu
- Recruiting
Vanderbilt Center for Human Nutrition
Nashville, Tennessee, 37212-1150
Dawn Adams, MD, 615-936-0192, dawn.w.adams@vumc.org
Sean Durkin, BS, 615-343-4216, sean.durkin@vumc.org
- Not yet recruiting
NYU Grossman School of Medicine
New York, New York, 10016
Jennifer Katz, MD, 212-263-3643, jennifer.katz@nyulangone.org
- Recruiting
Mount Sinai Medical Center
New York, New York, 10029
Kishore Iyer, MD, 212-241-2064, kishore.iyer@mountsinai.org
Brandy Haydel, 212-241-0255, brandy.haydel@mountsinai.org
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Michael Owen-Michaane, MD, 212-342-3881, mco2125@cumc.columbia.edu
Brett Gray, ANP, MPH, 212-305-1570, bg2168@cumc.columbia.edu
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3285
David F Mercer, MD, PhD, FRCS(C), 402-559-6955, dmercer@unmc.edu
Rachel Harper, RN, BSN, 402-559-1282, raharper@unmc.edu
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Valerianna Amorosa, MD, 215-873-4998, Valerianna.Amorosa@pennmedicine.upenn.edu
Kelly Wall, kelly.wall@pennmedicine.upenn.edu
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Benjamin Hall, MD, 401-444-4296, benjamin_hall@brown.edu
Marion Winkler, PhD, RD, LDN, CNSC, 401-444-4276, mwinkler@brownhealth.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Bradley Salonen, MD, 507-284-4805, Salonen.Bradley@mayo.edu
Pearl Buabeng, Buabeng.Pearl@mayo.edu
- Recruiting
Alchemi - Sugarland
Sugarland, Texas, 77478
Olumayowa Aderinto, MD, 346- 673-1322, o.aderintomd@alchemirc.com
Kenneth Morgan, MSc, 832-307-3100, k.morgan@alchemirc.com
- Recruiting
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Jeffrey Shupp, MD, 202-877-5133, jeffrey.w.shupp@medstar.net
Alison Ross, 202-877-5170, fbsrlresearch@medstar.net
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Hacettepe University Hospitals
Altındağ, Ankara, 06230
Prof. Dr. Meltem Gulhan Halil, (90) 532 786 45 35, meltemhalil@yahoo.com
Fatma Tamer, (90) 533 339 18 11, fatmatamer06@gmail.com
- Recruiting
Ankara University Ibni Sina Research and Application Hospital
Çankaya, Ankara, 06230
Prof. Dr. Seher Demirer, (90) 532 569 27 12, seher.demirer@gmail.com
Dr. Süleyman Utku Çelik, (90) 535 339 16 50, s.utkucelik@hotmail.com
- Recruiting
Ankara Bilkent City Hospital
Çankaya, Ankara, 06800
Prof. Dr. Mutlu Doganay, (90) 532 295 60 50, drmdoganay@gmail.com
Dr. Piril Tuncay, (90) 505 386 90 32, piril_tuncay@hotmail.com
- Recruiting
Istanbul University Faculty of Medicine, Capa State Hospital
Istanbul, Istanbul, 34093
Prof. Dr. Bulent Saka, (90) 532 366 65 41, bulent.saka@istanbul.edu.tr
Assoc. Prof. Dr. Mustafa Altinkaynak, (90) 506 658 15 97, mustafa.altinkaynak@istanbul.edu.tr
- Recruiting
Hacettepe University Hospitals
Yenimahalle, Ankara, 06560
Prof. Dr. Melda Türkoğlu, (90) 532 523 38 10, meldaturkoglu@yahoo.com
Assoc. Prof. Dr. Kamil Inci, (90) 544 212 25 45, kamilinci@gmail.com
About this study
Official title: A Phase 3, Prospective, Multicenter, Double-Blind, Randomized, Controlled, Adaptive Study To Demonstrate The Safety And Efficacy Of DEFENCATH® In Reducing Central Line-Associated Bloodstream Infections (CLABSIs) In Adult And Adolescent Participants Receiving Total Parenteral Nutrition (TPN) Via Central Venous Catheter (CVC)
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.
- Being tested
- (taurolidine and heparin) catheter lock solution, Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(taurolidine and heparin) catheter lock solutionDrug
for central venous catheter installation use
HeparinDrug
Heparin
| Study group | Role | What they receive |
|---|---|---|
| DefenCath® | Experimental | Not described Receives: Drug: (taurolidine and heparin) catheter lock solution |
| Control | Active comparator | Not described Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, but fail to complete the 12-month follow-up period of the study.
Measured: 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)
Compare the safety profile of DefenCath for use as a Catheter Lock Solution (CLS) in adult and adolescent participants receiving Total Parenteral Nutrition (TPN) through a Central Venous Catheter (CVC) to the control of heparin CLS
Measured: 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
Compare the safety profile of DefenCath for use as a CLS in adult and adolescent participants receiving TPN through a CVC to the control of heparin CLS
Measured: Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start14 May 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line Associated Blood Stream Infections (CLABSI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorMedix Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822426
- Sponsor's protocol ID
- NUTRI-GUARD
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharibg if protocol and ICF, pending FDA approval of this indication
- Expanded access
- Available