Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
NCT ID: NCT06714864
Last Updated: 2025-11-04
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
36 participants
INTERVENTIONAL
2025-07-08
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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)
NCT06822426
Analysis of CRBSI Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter
NCT02453646
Expanded Access Program for Patients At Risk for Catheter-related Infections Who Are Not Eligible for DefenCath® Clinical Trials
NCT06707480
Taurolidine in Haemodialysis Catheter Related Bacteraemia
NCT01243710
Efficacy Study to Evaluate B-Lock™ as an Antimicrobial Lock Solution in Dialysis Patients With a CVC
NCT01989091
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DefenCath®
(taurolidine and heparin) catheter lock solution
for central venous catheter instillation use
Control
Standard of Care
Site specific standard of care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
(taurolidine and heparin) catheter lock solution
for central venous catheter instillation use
Standard of Care
Site specific standard of care
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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 receiving adequate HD as assessed by the investigators and based on a single pool Kt/V measurement \> 1.2 (within the last 40 days).
* 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.
Exclusion Criteria
* 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.
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CorMedix
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's of Alabama/University of Alabama
Birmingham, Alabama, United States
Stanford
Palo Alto, California, United States
Nemours Children's Hospital - DE
Wilmington, Delaware, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PEDI-LOCK
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.