Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology

Launched by INSTITUT CURIE · Mar 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special solution called Taurolidine, which is used to lock catheters in place, compared to a standard saline solution. The goal is to see if using Taurolidine can help prevent infections related to catheters in children undergoing cancer treatment. Catheters are tubes that are inserted into the body to help with treatment, and preventing infections is very important for the health and safety of young patients.

To be eligible for this study, children must be 21 years old or younger and need to have a central catheter placed for their cancer treatment. They should also have regular check-ups at the hospital where the study is being conducted. It's important that they or their guardians give permission to participate. If a child has certain conditions, like specific types of cancer or allergies to the study medications, they may not be able to join. Participants in the trial will receive either the Taurolidine lock or the saline lock, and they will be closely monitored to see how well each option works in preventing infections. Overall, this study aims to improve the safety of catheter use in pediatric oncology patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient less than or equal to 21 years of age at inclusion.
• • 2. Patient for whom a central catheter is planned to be inserted\*, excluding a non-tunneled femoral or cervical external catheter or a peripherally inserted central catheter (as PICC line). \*1st catheter placement or placement following a relapse (this placement must take place at least one month after previous catheter removal).
• • 3. Patient treated for a cancer.
• • 4. Patient with regular follow-up in the inclusion center.
• • 5. Informed consent signed by the patient if adult or by legal representatives if minor.
• • 6. Patient benefiting from a social security coverage.
• • 7. Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.
• Exclusion Criteria:
• • 1. Patient with retinoblastoma.
• • 2. Allografted patient.
• • 3. Patient with a life expectancy of less than 6 months.
• • 4. Patient refusing to participate in the protocol.
• • 5. Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).
• • 6. Patient with known allergy to citrate or (cyclo)-Taurolidine.
• • 7. Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.
• • 8. Patient with an external femoral catheter.
• • 9. Patient with a PICCLINE-type peripheral venous inserted central catheter.
• • 10. Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
• • 11. Patient under guardianship and curatorship.