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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-A00618-45 |
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lack of recruitment
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Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.
The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.
Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Use of taurolidine in prevention of bloodstream infection related to central venous access |
|
| B | Placebo Comparator | Use of Physiologic Serum to compare to arm A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurolidine | Device | 2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of recurrence of catheter-related infection in each group | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Lecleire, MD | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP Beaujon Hospital | Clichy | France | ||||
| UH of Grenoble |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Physiologic Serum | Device | 2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months |
|
| Grenoble |
| France |
| UH of Lille | Lille | France |
| UH of Lyon | Lyon | France |
| UH of Nice | Nice | France |
| University Hospital of Rouen | Rouen | 76000 | France |
| UH of Toulouse | Toulouse | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |