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Trial Title:
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
NCT ID:
NCT05781295
Condition:
Children
Medical Device
Primary Prevention
Oncology
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
TaurolockTM
Description:
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.
Arm group label:
TauroLock™
Intervention type:
Device
Intervention name:
Physiological serum
Description:
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.
Arm group label:
Physiological serum (NaCl 0.9%)
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.
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Contact:
Last name:
Camille CORDERO, MD
Email:
camille.cordero@curie.fr
Facility:
Name:
Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Florence Rabian
Email:
florence.rabian@aphp.fr
Facility:
Name:
Armand Trousseau
Address:
City:
Paris
Zip:
75012
Country:
France
Status:
Recruiting
Contact:
Last name:
Fanny ALBY-LAURENT
Email:
fanny.alby-laurent@aphp.fr
Facility:
Name:
Robert Debre
Address:
City:
Paris
Zip:
75935
Country:
France
Status:
Recruiting
Contact:
Last name:
Benoit Brethon
Email:
benoit.brethon@aphp.fr
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Charlotte RIGAUD
Email:
charlotte.rigaud@gustaveroussy.fr
Start date:
January 19, 2024
Completion date:
July 23, 2028
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05781295
