Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorInstitut Curie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient less than or equal to 21 years of age at inclusion.
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.
Patient with regular follow-up in the inclusion center.
Disqualifiers
Patient with retinoblastoma.
Allografted patient.
Patient with a life expectancy of less than 6 months.
Patient refusing to participate in the protocol.
Trial design
Design model
Parallel
Treatments tested in this trial
TaurolockTM
DeviceThe 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
DeviceThe 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.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: TauroLock™Experimental treatment 1 intervention
Group B: Physiological serum (NaCl 0.9%)Placebo comparator 1 intervention
Trial outcomes
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.
Time frame
1000 catheter daysSecondary outcomes
1
Incidence of catheter colonizations.
Incidence of catheter colonizations.
Time frame
through study completion, an average of 56 months2
Catheter removal time related to catheter complication.
Catheter removal time related to catheter complication.
Time frame
through study completion, an average of 56 months3
Incidence of catheter removal related to catheter complication.
Incidence of catheter removal related to catheter complication.
Time frame
through study completion, an average of 56 months4
Incidence of local infections (with or without bacteremia).
Incidence of local infections (with or without bacteremia).
Time frame
through study completion, an average of 56 monthsSponsors and contacts
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Source ClinicalTrials.gov