Comparing Taurolidine and Saline Locks for Catheter Care in Children with Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentric, controlled, randomized, and double-blind study aims to evaluate the effectiveness of a Taurolidine lock compared to a standard saline lock in preventing catheter-related endoluminal infections in pediatric oncology patients. Participants will be monitored based on their specific cancer treatment protocols, with either Taurolock or physiological serum used at each catheter closure. The study focuses on children and young adults up to 21 years of age who require central catheter placement for cancer treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institut Curie
  Paris, France Recruiting
• Saint Louis
  Paris, France Recruiting
• Armand Trousseau
  Paris, France Recruiting
• Robert Debre
  Paris, France Recruiting
• Gustave Roussy
  Villejuif, France Recruiting

Study contacts

• Study coordinator: Camille CORDERO, MD
• Email: camille.cordero@curie.fr
• Phone: +33172389309

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.