AzTrials
AzTrials

Catheter-Related InfectionsPhase 4NCT06714864

Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age

A Phase 4 study testing (taurolidine and heparin) catheter lock solution in people with Catheter-Related Infections, run by CorMedix Therapeutics at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Catheter-Related Infections
What is being tested?
(taurolidine and heparin) catheter lock solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
6 sitesUnited States
Study dates
8 Jul 2025to Apr 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • All participants must be < 18 years of age and must meet the following inclusion criteria:
  • The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant's legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand.
  • A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day according to the schedule of activities (SoA) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant during the scheduled study visits; accurately and reliably dispense study intervention as directed.
  • The participant has kidney failure and undergoes chronic hemodialysis (HD) at least 2 times per week.
  • The participant has an HD central venous catheter (CVC) and is placed in a jugular or subclavian vein.
  • The participant has demonstrated the ability to achieve an appropriate minimum blood flow (Qb) for the participant's relative age and weight for at least 2 consecutive dialysis sessions to enable successful HD.
Show all 21Show fewer
  • The participant is likely to require the use of a CVC for at least 60 days, based on clinical assessment.
  • The participant is willing to comply with specified follow-up evaluations and prescribed dialysis therapy.
  • The participant is not expected to expire within 180 days, based on clinical assessment.
  • Female participants of childbearing potential:
  • Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last administration of study treatment.
  • Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last administration of study treatment:
  • True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable).
  • Combined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.
  • Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.
  • Bilateral tubal occlusion/ligation.
  • Intrauterine device.
  • Intrauterine hormone releasing system.
  • Vasectomized partner.
  • NOTE: If the childbearing potential changes after start of the study (e.g., a premenarchal female participant experiences menarche) or the risk of pregnancy changes (e.g., a female participant who is not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception, or a male participant must use a condom. If reproductive status is questionable, additional evaluation should be considered.
  • Male participants who are sexually active with a female partner of childbearing potential must agree to use male condoms and 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 administration of study treatment.

Who cannot join

  • Any participant who is currently receiving systemic antibiotics. Topical antibiotic use is permitted.
  • Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection.
  • The participant has received any thrombolytic treatment (i.e., tissue plasminogen activator [tPA] - Cathflo®), not as part of the institution's standard of care for patency management, in their current catheter within 30 days of randomization.
  • The fill volume of catheter lumen(s) is unknown or cannot be determined.
  • The participant uses any type of antimicrobial-coated or heparin-coated catheter.
  • Documented chronic bleeding diathesis, active or recurrent bleeding within 30 days prior to randomization.
Show all 19Show fewer
  • Documented history of an atrial thrombus or known hypercoagulable state.
  • The participant has open, non-healing skin ulcers.
  • Any participant who has received an allogeneic hematopoietic stem cell transplant within the last year.
  • The participant has current requirement for systemic chemotherapy and/or immunosuppression and absolute neutrophil count <500 cells/µL that occurred in the past 4 weeks.
  • An active malignancy that either in and of itself or by virtue of its treatment with chemotherapy or biologic therapy results in neutropenia, leukopenia and/or immunosuppression.
  • Known allergy or absolute contraindication to taurolidine, citrate, or heparin, or a history of heparin induced thrombocytopenia (HIT).
  • Unstable malignancy.
  • Cirrhosis with encephalopathy.
  • The participant is currently taking another medication with known systemic drug interaction with taurolidine, citrate, or heparin.
  • The participant is anticipated to receive a renal transplant within 90 days (participants can be on the transplant list, but a participant with a known or anticipated transplant date within the next 90 days should be excluded).
  • The participant has a clinically significant cardiac rhythm or functional disorder.
  • The participant has severe hypoxemia, respiratory acidosis, asphyxia, or hypotension prior to randomization based on assessment of the investigator.
  • Any other medical condition which renders the participant unable to or unlikely to complete the study, or which would interfere with optimal participation in the study or produce significant risk to the participant.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liz Hurlburt contact

9085179500

lhurlburt@cormedix.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • Children's of Alabama/University of Alabama

    Birmingham, Alabama, 35233

    Sahar Fathallah-Shaykh, MD, 205-638-9781, sfshaykh@uabmc.edu

    Susan Keeling, 205-638-2792, skeeling@uabmc.edu

    Recruiting

  • Cook Children's Health Care System

    Fort Worth, Texas, 76104

    Robert Gillespie, MD, 817-879-3500, Robert.Gillespie@cookchildrens.org

    Jamie Chapman, 817-264-2712, Jamie.Chapman@cookchildrens.org

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Kenneth Lieberman, MD, 551-996-8228, Kenneth.lieberman@hmhn.org

    Sabrina Kdiry, RNC, 551-996-6588, Sabrina.kdiry@hmhn.org

    Recruiting

  • Stanford

    Palo Alto, California, 94304

    Shina Menon, MD, 650-721-5807, shinam@stanford.edu

    Amanda Tapia, 831-710-6196, amandatapia@stanford.edu

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    Anjali Nayak, MD, 602-933-0574, anayak@phoenixchildrens.com

    Elisbeth Reyes, 732-788-5775 ext. 732-788-5775, ereyes1@phoenixchildrens.com

    Recruiting

  • Nemours Children's Hospital - DE

    Wilmington, Delaware, 19803

    Ali M Onder, MD, 302-651-4426, Alimirza.Onder@nemours.org

    Jessica Rayfield, 302-298-2777, jessica.rayfield@nemours.org

    Recruiting

Other trials in United States

About this study

Official title: An Open-Label, Two-Arm (DefenCath® vs. Institutional Standard of Care) Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to Less Than 18 Years of Age With Kidney Failure Receiving Hemodialysis Via a Central Venous Catheter

This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.

Being tested
(taurolidine and heparin) catheter lock solution, Standard of Care
Medical subject headings
Catheter-Related Infections

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

    Also called DefenCath®

    for central venous catheter instillation use

  • Standard of CareDrug

    Site specific standard of care

Study groups in NCT06714864
Study groupRoleWhat they receive
DefenCath®ExperimentalNot described
Receives: Drug: (taurolidine and heparin) catheter lock solution
ControlActive comparatorNot described
Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI)

    To demonstrate the effectiveness of DefenCath as a catheter lock solution (CLS) for prevention of CRBSI in pediatric participants receiving chronic hemodialysis (HD) through a central venous catheter (CVC) for the treatment of kidney failure.

    Measured: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

  2. Descriptive analysis characterizing the relative rates of deaths, AEs, and SAEs

    To demonstrate safety of DefenCath as a CLS in pediatric participants receiving chronic HD through a CVC for the treatment of kidney failure

    Measured: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Secondary outcomes (1)

  1. Time to catheter removal due to CRBSI

    To evaluate the catheter removal due to CRBSI in pediatric participants who are receiving chronic HD through a CVC for kidney failure.

    Measured: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start8 Jul 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06714864
Sponsor's protocol ID
PEDI-LOCK
Status last verified
Sep 2026
First submitted
2 Dec 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing (taurolidine and heparin) catheter lock solution in people with Catheter-Related Infections, run by CorMedix Therapeutics at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liz Hurlburt (9085179500, lhurlburt@cormedix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI) (time frame: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06714864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in