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

Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.

This study tests whether using a Taurolidine lock instead of a regular saline lock can help prevent infections in central catheters for kids and young adults with cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: N/A to 21 Years
• Sex: All
• Sponsor: Institut Curie (Academic / other)
• Locations: 5 sites (Paris and 4 other locations)
• Trial ID: NCT05781295 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and young adults up to 21 years old who are undergoing treatment for cancer and require a central catheter.

Not a fit: Patients with retinoblastoma, those who are allografted, or those with a life expectancy of less than 6 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of infections related to central catheters in pediatric oncology patients.

How similar studies have performed: Previous studies have shown promising results with the use of Taurolidine in preventing infections in similar patient populations, indicating potential for success in this approach.

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.

Where this trial is running

Paris and 4 other locations

• 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

Conditions Children; Medical Device; Primary Prevention; Oncology