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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
148
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.
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.
Institut Curie
Paris, France
RECRUITINGSaint Louis
Paris, France
RECRUITINGArmand Trousseau
Paris, France
RECRUITINGComparison 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 days
Incidence of catheter colonizations.
Incidence of catheter colonizations.
Time frame: through study completion, an average of 56 months
Catheter removal time related to catheter complication.
Catheter removal time related to catheter complication.
Time frame: through study completion, an average of 56 months
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 months
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 months
Incidence of catheter occlusions.
Incidence of catheter occlusions.
Time frame: through study completion, an average of 56 months
Incidence of thrombotic complications.
Incidence of thrombotic complications.
Time frame: through study completion, an average of 56 months
Number and hospitalization duration related to catheter complications.
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Robert Debre
Paris, France
RECRUITINGGustave Roussy
Villejuif, France
RECRUITINGNumber and hospitalization duration related to catheter complications.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 56 months