Informations générales (source: ClinicalTrials.gov)
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology. (PEDIALOCK)
Interventional
N/A
Institut Curie (Voir sur ClinicalTrials)
janvier 2024
juillet 2028
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:39 | Contacter | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Charlotte RIGAUD | 18/03/2024 12:13:20 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | Fanny ALBY-LAURENT | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Robert Debré | Benoit Brethon | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Saint Louis - 75010 - Paris - France | Florence Rabian | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
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.