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Effect of Taurolidin on Prevention of Bloodstream Infection (Nutrilock)

Primary Purpose

Sepsis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Taurolidine
Physiologic Serum
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sepsis focused on measuring Home Parenteral Nutrition, Sepsis Prevention, Central Venous Catheters, Taurolidine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • APHP Beaujon Hospital
  • UH of Grenoble
  • UH of Lille
  • UH of Lyon
  • UH of Nice
  • University Hospital of Rouen
  • UH of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Use of taurolidine in prevention of bloodstream infection related to central venous access

Use of Physiologic Serum to compare to arm A

Outcomes

Primary Outcome Measures

Number of recurrence of catheter-related infection in each group

Secondary Outcome Measures

Full Information

First Posted
October 16, 2007
Last Updated
March 4, 2013
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT00545831
Brief Title
Effect of Taurolidin on Prevention of Bloodstream Infection
Acronym
Nutrilock
Official Title
Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Home Parenteral Nutrition, Sepsis Prevention, Central Venous Catheters, Taurolidine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Use of taurolidine in prevention of bloodstream infection related to central venous access
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Use of Physiologic Serum to compare to arm A
Intervention Type
Device
Intervention Name(s)
Taurolidine
Intervention Description
2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
Intervention Type
Device
Intervention Name(s)
Physiologic Serum
Intervention Description
2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
Primary Outcome Measure Information:
Title
Number of recurrence of catheter-related infection in each group
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Lecleire, MD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHP Beaujon Hospital
City
Clichy
Country
France
Facility Name
UH of Grenoble
City
Grenoble
Country
France
Facility Name
UH of Lille
City
Lille
Country
France
Facility Name
UH of Lyon
City
Lyon
Country
France
Facility Name
UH of Nice
City
Nice
Country
France
Facility Name
University Hospital of Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
UH of Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

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Effect of Taurolidin on Prevention of Bloodstream Infection

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