Effect of Taurolidin on Prevention of Bloodstream Infection

Not Applicable

Terminated

• Conditions: Sepsis
• Interventions: Device: Taurolidine; Device: Physiologic Serum

• Registration Number: NCT00545831
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Age superior to 18 years
• Home parenteral nutrition on tunnelized central venous catheters
• Bloodstream infection confirmed by differential hemocultures
• Informed consent form signed
• Negative B-HCG test

Exclusion Criteria

• Subject unable to give his informed consent
• Pregnancy
• Subject who have a two or three-way catheter, or a non-tunnelized central venous catheter
• Hospital related infection
• Central venous catheters placed since less than 15 days
• Neutropenia < 500 PNN/mm3
• Fungal Infection, polymicrobial who need ablation of the central venous catheters
• No-response to clinical treatment of the Infection
• Septic thrombophlebitis
• Chemotherapy ongoing
• On going malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Taurolidine	Use of taurolidine in prevention of bloodstream infection related to central venous access
B	Physiologic Serum	Use of Physiologic Serum to compare to arm A

Primary Outcome Measures

Name	Time	Method
Number of recurrence of catheter-related infection in each group	6 months

Trial Locations

Locations (7)

UH of Lille; 🇫🇷 Lille, France

UH of Nice; 🇫🇷 Nice, France

APHP Beaujon Hospital; 🇫🇷 Clichy, France

University Hospital of Rouen; 🇫🇷 Rouen, France

UH of Lyon; 🇫🇷 Lyon, France

UH of Grenoble; 🇫🇷 Grenoble, France

UH of Toulouse; 🇫🇷 Toulouse, France