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New catheter lock aims to stop deadly infections in home nutrition patients

NCT ID NCT06822426

Disease control Sponsor: CorMedix Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether a catheter lock solution called DefenCath can prevent central line-associated bloodstream infections (CLABSIs) in adults who receive total parenteral nutrition (TPN) at home through a central line. About 200 participants will be randomly assigned to receive either DefenCath or a standard heparin lock. The study will compare how many people in each group develop an infection within 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
taurolidine and heparin catheter lock solution
What this could lead to
If successful, this could provide a new way to prevent dangerous bloodstream infections in people who need long-term nutrition through a central line.
What could go wrong
This is a mid-stage trial with 200 participants, so results may not apply to everyone. The treatment involves a catheter lock solution, which carries risks like bleeding or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Participants who are resident within the US and Türkiye. 2. Participants who are male or female, aged ≥18 years at the time of consent. 3. Participants must sign and provide informed consent. 4. Participants who have a permanent tunneled CVC or permanent 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 (\>6 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. 10. Male or female participants: 1. 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). 2. 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. 11. Participants who comply with all study procedures and follow-up evaluations. 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. 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central line associated blood stream infections (clabsi)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alchemi - Sugarland

    RECRUITING

    Sugarland, Texas, 77478, United States

  • Ankara Bilkent City Hospital

    RECRUITING

    Çankaya, Ankara, 06800, Turkey (Türkiye)

  • Ankara University Ibni Sina Research and Application Hospital

    RECRUITING

    Çankaya, Ankara, 06230, Turkey (Türkiye)

  • Bioresearch Partner

    RECRUITING

    Doral, Florida, 33122, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Duke University Hospital

    WITHDRAWN

    Durham, North Carolina, 27710, United States

  • Emory University Hospital - GCRC

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hacettepe University Hospitals

    RECRUITING

    Altındağ, Ankara, 06230, Turkey (Türkiye)

  • Hacettepe University Hospitals

    RECRUITING

    Yenimahalle, Ankara, 06560, Turkey (Türkiye)

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Istanbul University Faculty of Medicine, Capa State Hospital

    RECRUITING

    Istanbul, Istanbul, 34093, Turkey (Türkiye)

  • Johns Hopkins Clinical Research Unit

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Health Research Institute

    RECRUITING

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

    Contact Email: •••••@•••••

  • Mount Sinai Medical Center

    RECRUITING

    New York, New York, 10029, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90024, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198-3285, United States

  • Vanderbilt Center for Human Nutrition

    RECRUITING

    Nashville, Tennessee, 37212-1150, United States

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