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

NCT05781295 | Recruiting DMC

• 1 other identifier: IC 2017-12
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 5

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.

Conditions

Children; Medical Device; Primary Prevention; Oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of catheter colonizations.

  through study completion, an average of 56 months

• Catheter removal time related to catheter complication.

  through study completion, an average of 56 months

• Incidence of catheter removal related to catheter complication.

  through study completion, an average of 56 months

• Incidence of local infections (with or without bacteremia).

  through study completion, an average of 56 months

• Incidence of catheter occlusions.

  through study completion, an average of 56 months

Study Arms (2)

TauroLock™

EXPERIMENTAL

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

Physiological serum (NaCl 0.9%)

PLACEBO COMPARATOR

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

Interventions

TaurolockTM DEVICE

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.

TauroLock™

Physiological serum DEVICE

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.

Physiological serum (NaCl 0.9%)

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Informed consent signed by the patient if adult or by legal representatives if minor.
• Patient benefiting from a social security coverage.
• Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (5)

Institut Curie

Paris, 75005, France

RECRUITING

Saint Louis

Paris, 75010, France

RECRUITING

Armand Trousseau

Paris, 75012, France

RECRUITING

Robert Debre

Paris, 75935, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Camille CORDERO, MD

  Institut Curie

  STUDY DIRECTOR

Central Study Contacts

Camille CORDERO, MD

CONTACT

+33172389309; camille.cordero@curie.fr

Marie-Emmanuelle Legrier, PhD

CONTACT

drci.promotion@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 23, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): July 23, 2028
• Study Completion (Estimated): July 23, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (5)