NCT05781295 Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
| NCT ID | NCT05781295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Curie |
| Condition | Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2028-07-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2024-01-19 with a primary completion date of 2028-07-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Camille CORDERO, MD
STUDY DIRECTOR
Institut Curie
Frequently Asked Questions
Who can join the NCT05781295 clinical trial?
This trial is open to participants of all sexes, up to 21 Years, studying Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05781295 currently recruiting?
Yes, NCT05781295 is actively recruiting participants. Contact the research team at camille.cordero@curie.fr for enrollment information.
Where is the NCT05781295 trial being conducted?
This trial is being conducted at Paris, France, Paris, France, Paris, France, Paris, France and 1 additional location.
Who is sponsoring the NCT05781295 clinical trial?
NCT05781295 is sponsored by Institut Curie. The principal investigator is Camille CORDERO, MD at Institut Curie. The trial plans to enroll 148 participants.