RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-07-08

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06714864

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* All participants must be \< 18 years of age and must meet the following	* The participant has received systemic antibiotics within the last 14 days. 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. * Documented history of an atrial thrombus or known hypercoagulable state. * The participant has open, non-healing skin ulcers. * Current requirement for systemic immunosuppression that would increase risk of infection, such as: * High dose steroid. Low-dose steroids, such as routinely used for maintenance of organ transplants, are acceptable. * Methotrexate dose sufficiently high to suppress white blood cells (WBC) below 5,000 cells/µL. * Biologic immunomodulators (anti-tumour necrosis factor, anti-CD4 antibody, etc.) within 30 days. * Azathioprine. * Calcineurin inhibitors (dose determined by investigator). * Sirolimus. * 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.

Inclusion Criteria

Exclusion Criteria

* All participants must be \< 18 years of age and must meet the following

* The participant has received systemic antibiotics within the last 14 days. 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.
* Documented history of an atrial thrombus or known hypercoagulable state.
* The participant has open, non-healing skin ulcers.
* Current requirement for systemic immunosuppression that would increase risk of infection, such as:
* High dose steroid. Low-dose steroids, such as routinely used for maintenance of organ transplants, are acceptable.
* Methotrexate dose sufficiently high to suppress white blood cells (WBC) below 5,000 cells/µL.
* Biologic immunomodulators (anti-tumour necrosis factor, anti-CD4 antibody, etc.) within 30 days.
* Azathioprine.
* Calcineurin inhibitors (dose determined by investigator).
* Sirolimus.
* 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.

Contacts and Locations

Study Contact

Liz Hurlburt

CONTACT

9085179500

lhurlburt@cormedix.com

Study Locations (Sites)

Nemours Children's Hospital - DE

Wilmington, Delaware, 19803

United States

Collaborators and Investigators

Sponsor: CorMedix

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-08

Study Completion Date2026-03

Study Record Updates

Study Start Date2025-07-08

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Catheter-Related Infections