Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00545831
Status:
TERMINATED
Last Update Posted:
2013-03-05
First Post:
2007-10-16
Brief Title:
Effect of Taurolidin on Prevention of Bloodstream Infection
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nutrilock
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-A00618-45 | None | None | None |