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

Last updated: June 17, 2025
Sponsor: Institut Curie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Neoplasms

Treatment

TaurolockTM

Physiological serum

Clinical Study ID

NCT05781295
IC 2017-12 PEDIALOCK
  • Ages < 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 anon-tunneled femoral or cervical external catheter or a peripherally insertedcentral catheter (as PICC line). *1st catheter placement or placement following arelapse (this placement must take place at least one month after previous catheterremoval).

  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 ifminor.

  6. Patient benefiting from a social security coverage.

  7. Time between the date of catheter placement and the planned date for the firstsolution lock injection less than 6 weeks.

Exclusion

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 preventionlock (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.

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: TaurolockTM
Phase:
Study Start date:
January 19, 2024
Estimated Completion Date:
July 23, 2028

Study Description

The patient will be followed according to the type of pathology and the respective treatment protocol either Taurolock or physiological serum at each time cathter will be used.

Connect with a study center

  • Armand Trousseau

    Paris, 75012
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75005
    France

    Active - Recruiting

  • Robert Debre

    Paris, 75935
    France

    Active - Recruiting

  • Saint Louis

    Paris, 75010
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

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