Clinical trial NCT05781295: Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children
Medical Device
Primary Prevention
Oncology
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 148
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Comparison of the incidence of catheter-related infection per 1000 catheter days.
timeFrame: 1000 catheter days
Secondary outcomes:
measure: Incidence of catheter colonizations.
timeFrame: through study completion, an average of 56 months
measure: Catheter removal time related to catheter complication.
timeFrame: through study completion, an average of 56 months
measure: Incidence of catheter removal related to catheter complication.
timeFrame: through study completion, an average of 56 months
measure: Incidence of local infections (with or without bacteremia).
timeFrame: through study completion, an average of 56 months
measure: Incidence of catheter occlusions.
timeFrame: through study completion, an average of 56 months
measure: Incidence of thrombotic complications.
timeFrame: through study completion, an average of 56 months
measure: Number and hospitalization duration related to catheter complications.
timeFrame: through study completion, an average of 56 months
measure: Number and frequency of adverse events linked to lock.
timeFrame: through study completion, an average of 56 months
measure: Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection.
timeFrame: through study completion, an average of 56 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Saint Louis
city: Paris
country: France
facility: Armand Trousseau
city: Paris
country: France
facility: Robert Debre
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References: