Children, Medical Device, Primary Prevention, Oncology
Conditions
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.
Detailed description
The patient will be followed according to the type of pathology and the respective treatment protocol either Taurolock or physiological serum at each time cathter will be used.
Interventions
DEVICETaurolockTM
The patient will be followed up to a maximum of 6 months after randomization after have a TaurolockTM injected each time catheter will be used.
DEVICEPhysiological serum
The patient will be followed up to a maximum of 6 months after randomization after have a Physiological serum injected each time catheter will be used.
Sponsors
Institut Curie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the incidence of catheter-related infection per 1000 catheter days. | 1000 catheter days | Comparison of the incidence of catheter-related infection per 1000 catheter days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of catheter colonizations. | through study completion, an average of 56 months | Incidence of catheter colonizations. |
| Catheter removal time related to catheter complication. | through study completion, an average of 56 months | Catheter removal time related to catheter complication. |
| Incidence of catheter removal related to catheter complication. | through study completion, an average of 56 months | Incidence of catheter removal related to catheter complication. |
| Incidence of local infections (with or without bacteremia). | through study completion, an average of 56 months | Incidence of local infections (with or without bacteremia). |
| Incidence of catheter occlusions. | through study completion, an average of 56 months | Incidence of catheter occlusions. |
| Incidence of thrombotic complications. | through study completion, an average of 56 months | Incidence of thrombotic complications. |
| Number and hospitalization duration related to catheter complications. | through study completion, an average of 56 months | Number and hospitalization duration related to catheter complications. |
| Number and frequency of adverse events linked to lock. | through study completion, an average of 56 months | Number and frequency of adverse events linked to lock. |
| 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 | Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection. |
Countries
France
Contacts
CONTACTCamille CORDERO, MD
CONTACTMarie-Emmanuelle Legrier, PhD
STUDY_DIRECTORCamille CORDERO, MD
Institut Curie
Outcome results
None listed