Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Children, Medical Device, Primary Prevention, Oncology

Intervention / Treatment
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* Device: TaurolockTM
* Device: Physiological serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient less than or equal to 21 years of age at inclusion. 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). Patient treated for a cancer. Patient with regular follow-up in the inclusion center. Informed consent signed by the patient if adult or by legal representatives if minor. Patient benefiting from a social security coverage. Exclusion Criteria: Patient with retinoblastoma. Allografted patient. Patient with a life expectancy of less than 6 months. Patient refusing to participate in the protocol. Patient already receiving a central venous catheter-related infection prevention lock (ILCVC). Patient with known allergy to citrate or (cyclo)-Taurolidine. Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine. Patient with an external femoral catheter. Patient with a PICCLINE-type peripheral venous inserted central catheter. Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons. Patient under guardianship and curatorship. Catheter placement over 15 days.

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TauroLock™<br>The patient will be followed up to a maximum of 6 months after randomization after have a Taurlock™ injected each time catheter will be used. | Device: TaurolockTM<br>* 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.<br>|
| Placebo Comparator: Physiological serum (NaCl 0.9%)<br>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. | Device: Physiological serum<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of catheter colonizations. | Incidence of catheter colonizations. | through study completion, an average of 56 months | 
| Catheter removal time related to catheter complication. | Catheter removal time related to catheter complication. | through study completion, an average of 56 months | 
| Incidence of catheter removal related to catheter complication. | Incidence of catheter removal related to catheter complication. | through study completion, an average of 56 months | 
| Incidence of local infections (with or without bacteremia). | Incidence of local infections (with or without bacteremia). | through study completion, an average of 56 months | 
| Incidence of catheter occlusions. | Incidence of catheter occlusions. | through study completion, an average of 56 months | 
| Incidence of thrombotic complications. | Incidence of thrombotic complications. | through study completion, an average of 56 months | 
| Number and hospitalization duration related to catheter complications. | Number and hospitalization duration related to catheter complications. | through study completion, an average of 56 months | 
| 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 | 
| 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 |