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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Children; Primary Prevention; Oncology; Medical Device
• Intervention / Treatment: Device: TaurolockTM; Device: Physiological serum

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 Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camille CORDERO; Phone Number: +33 1 72 38 93 09; Email: camille.cordero@curie.fr
• Study Contact Backup: Name: Cyrine Ezzili; Phone Number: +33 1 47 11 16 57; Email: cyrine.ezzili@curie.fr

Study Locations

• France
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Contact: Camille CORDERO, MD; Email: camille.cordero@curie.fr
  • Paris, France, 75010
    • Not yet recruiting
    • Saint Louis
    • Contact: Florence Rabian; Email: florence.rabian@aphp.fr
  • Paris, France, 75012
    • Recruiting
    • Armand Trousseau
    • Contact: Fanny ALBY-LAURENT; Email: fanny.alby-laurent@aphp.fr
  • Paris, France, 75935
    • Recruiting
    • Robert Debre
    • Contact: Benoit Brethon; Email: benoit.brethon@aphp.fr
  • Villejuif, France, 94805
    • Recruiting
    • Gustave Roussy
    • Contact: Charlotte RIGAUD; Email: charlotte.rigaud@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TauroLock™; 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; 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.
Placebo Comparator: Physiological serum (NaCl 0.9%); 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): July 23, 2028
• Study Completion (Estimated): July 23, 2028

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IC 2017-12 PEDIALOCK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No