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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TauroLockâ„¢ | Experimental | The patient will be followed up to a maximum of 6 months after randomization after have a Taurlockâ„¢ injected each time catheter will be used. |
|
| Physiological serum (NaCl 0.9%) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TaurolockTM | Device | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the incidence of catheter-related infection per 1000 catheter days. | Comparison of the incidence of catheter-related infection per 1000 catheter days. | 1000 catheter days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of catheter colonizations. | Incidence of catheter colonizations. | through study completion, an average of 56 months |
| Catheter removal time related to catheter complication. | Catheter removal time related to catheter complication. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camille CORDERO, MD | Contact | +33172389309 | camille.cordero@curie.fr | |
| Marie-Emmanuelle Legrier, PhD | Contact | drci.promotion@curie.fr |
| Name | Affiliation | Role |
|---|---|---|
| Camille CORDERO, MD | Institut Curie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Recruiting | Paris | 75005 | France |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Physiological serum | Device | 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. |
|
| through study completion, an average of 56 months |
| Incidence of catheter removal related to catheter complication. | Incidence of catheter removal related to catheter complication. | through study completion, an average of 56 months |
| Incidence of local infections (with or without bacteremia). | Incidence of local infections (with or without bacteremia). | through study completion, an average of 56 months |
| Incidence of catheter occlusions. | Incidence of catheter occlusions. | through study completion, an average of 56 months |
| Incidence of thrombotic complications. | Incidence of thrombotic complications. | through study completion, an average of 56 months |
| Number and hospitalization duration related to catheter complications. | Number and hospitalization duration related to catheter complications. | 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. | 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. | through study completion, an average of 56 months |
| Saint Louis | Recruiting | Paris | 75010 | France |
|
| Armand Trousseau | Recruiting | Paris | 75012 | France |
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| Robert Debre | Recruiting | Paris | 75935 | France |
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| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
|