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

Children Clinical Trial

— PEDIALOCK  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781295
• Other study ID #: IC 2017-12 PEDIALOCK
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: July 23, 2028

Study information

• Verified date: April 2024
• Source: Institut Curie
• Contact: Camille CORDERO
• Phone: +33 1 72 38 93 09
• Email: camille.cordero[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: July 23, 2028
• Est. primary completion date: July 23, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Medical Device
• Neoplasms
• Oncology
• Primary Prevention

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Armand Trousseau	Paris
France	Institut Curie	Paris
France	Robert Debre	Paris
France	Saint Louis	Paris
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of catheter colonizations.	Incidence of catheter colonizations.	through study completion, an average of 56 months
Secondary	Catheter removal time related to catheter complication.	Catheter removal time related to catheter complication.	through study completion, an average of 56 months
Secondary	Incidence of catheter removal related to catheter complication.	Incidence of catheter removal related to catheter complication.	through study completion, an average of 56 months
Secondary	Incidence of local infections (with or without bacteremia).	Incidence of local infections (with or without bacteremia).	through study completion, an average of 56 months
Secondary	Incidence of catheter occlusions.	Incidence of catheter occlusions.	through study completion, an average of 56 months
Secondary	Incidence of thrombotic complications.	Incidence of thrombotic complications.	through study completion, an average of 56 months
Secondary	Number and hospitalization duration related to catheter complications.	Number and hospitalization duration related to catheter complications.	through study completion, an average of 56 months
Secondary	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
Secondary	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