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

Eligibility 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.