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Tests treatment safety and results for Catheter-Related Infections
Official title Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
ClinicalTrials.gov ID: NCT06714864
What this study is testing
What is (taurolidine and heparin) catheter lock solution?
(taurolidine and heparin) catheter lock solution is an investigational medicine, being studied as a potential treatment for catheter-related infections.
Also referred to as DefenCath®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- All participants must be \< 18 years of age and must meet the following
- The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant's legal guardian and...
- A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
Who can join
- All participants must be \< 18 years of age and must meet the following
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Palo Alto, California, United States
- Wilmington, Delaware, United States
- Hackensack, New Jersey, United States
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Palo Alto, California, United States; Wilmington, Delaware, United States; Hackensack, New Jersey, United States; Fort Worth, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.