Children Clinical Trial
— PEDIALOCKOfficial title:
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.
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.
Status | Recruiting |
Enrollment | 148 |
Est. completion date | July 23, 2028 |
Est. primary completion date | July 23, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Armand Trousseau | Paris | |
France | Institut Curie | Paris | |
France | Robert Debre | Paris | |
France | Saint Louis | Paris | |
France | Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Institut Curie |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the incidence of catheter-related infection per 1000 catheter days. | Comparison of the incidence of catheter-related infection per 1000 catheter days. | 1000 catheter days | |
Secondary | Incidence of catheter colonizations. | Incidence of catheter colonizations. | through study completion, an average of 56 months | |
Secondary | Catheter removal time related to catheter complication. | Catheter removal time related to catheter complication. | through study completion, an average of 56 months | |
Secondary | Incidence of catheter removal related to catheter complication. | Incidence of catheter removal related to catheter complication. | through study completion, an average of 56 months | |
Secondary | Incidence of local infections (with or without bacteremia). | Incidence of local infections (with or without bacteremia). | through study completion, an average of 56 months | |
Secondary | Incidence of catheter occlusions. | Incidence of catheter occlusions. | through study completion, an average of 56 months | |
Secondary | Incidence of thrombotic complications. | Incidence of thrombotic complications. | through study completion, an average of 56 months | |
Secondary | Number and hospitalization duration related to catheter complications. | Number and hospitalization duration related to catheter complications. | through study completion, an average of 56 months | |
Secondary | Number and frequency of adverse events linked to lock. | Number and frequency of adverse events linked to lock. | through study completion, an average of 56 months | |
Secondary | Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection. | Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection. | through study completion, an average of 56 months |
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