Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Pa
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.
| Condition(s) | Children, Medical Device, Primary Prevention, Oncology |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 21 Years |
| Sex | All |
| Lead sponsor | Institut Curie |
| Locations | Paris, France; Paris, France; Paris, France; Paris, France; Villejuif, France |
| Start date | 2024-01-19 |
| NCT ID | NCT05781295 |
| Official listing | https://clinicaltrials.gov/study/NCT05781295 |