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.
NCT Number: NCT05781295
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.
Interested in participating?
Request InfoUp to 21 year
All sexes
Interventional
Not applicable
Armand Trousseau, Paris, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1000 catheter days
Comparison of the incidence of catheter-related infection per 1000 catheter days.
Time frame: through study completion, an average of 56 months
Incidence of catheter colonizations.
Time frame: through study completion, an average of 56 months
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.
Time frame: through study completion, an average of 56 months
Incidence of local infections (with or without bacteremia).
Time frame: through study completion, an average of 56 months
Incidence of catheter occlusions.
Time frame: through study completion, an average of 56 months
Incidence of thrombotic complications.
Time frame: through study completion, an average of 56 months
Number 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.
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.
Contact information is provided by the study sponsor or research team.
Camille CORDERO, MD
CONTACT
Marie-Emmanuelle Legrier, PhD
CONTACT
Institut Curie
Other
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.
Acronym: PEDIALOCK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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