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

Not Applicable

Recruiting

• Conditions: Children; Oncology; Medical Device; Primary Prevention
• Interventions: Device: Physiological serum; Device: TaurolockTM

• Registration Number: NCT05781295
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-23
• Study Start: 2024-01-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2028-07-23
• Study Completion: 2028-07-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiological serum (NaCl 0.9%)	Physiological 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.
TauroLock™	TaurolockTM	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 catheter colonizations.	through study completion, an average of 56 months	Incidence of catheter colonizations.
Incidence of catheter occlusions.	through study completion, an average of 56 months	Incidence of catheter occlusions.
Catheter removal time related to catheter complication.	through study completion, an average of 56 months	Catheter removal time related to catheter complication.
Number and hospitalization duration related to catheter complications.	through study completion, an average of 56 months	Number and hospitalization duration related to catheter complications.
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.
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 thrombotic complications.	through study completion, an average of 56 months	Incidence of thrombotic 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.

Trial Locations

Locations (5)

Saint Louis; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Paris, France

Armand Trousseau; 🇫🇷 Paris, France

Robert Debre; 🇫🇷 Paris, France

Gustave Roussy; 🇫🇷 Villejuif, France