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

Recruiting now · Not applicable

Conditions studied: Children, Medical Device, Primary Prevention, Oncology

In brief

Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study.

Key facts

Study ID

NCT05781295

Run by

Institut Curie

People needed

148

Starts

2024-01-19

Expected to finish

2028-07-23

Last updated by the study team

2026-02-20

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient less than or equal to 21 years of age at inclusion.
• 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).
• Patient treated for a cancer.
• Patient with regular follow-up in the inclusion center.
• Informed consent signed by the patient if adult or by legal representatives if minor.
• Patient benefiting from a social security coverage.
• Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.

You may not qualify if…

• Patient with retinoblastoma.
• Allografted patient.
• Patient with a life expectancy of less than 6 months.
• Patient refusing to participate in the protocol.
• Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).
• Patient with known allergy to citrate or (cyclo)-Taurolidine.
• Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.
• Patient with an external femoral catheter.
• Patient with a PICCLINE-type peripheral venous inserted central catheter.
• Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
• Patient under guardianship and curatorship.

Where it is running

• Institut Curie — Paris, France (enrolling)
• Saint Louis — Paris, France (enrolling)
• Armand Trousseau — Paris, France (enrolling)
• Robert Debre — Paris, France (enrolling)
• Gustave Roussy — Villejuif, France (enrolling)

Full record on ClinicalTrials.gov

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