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Effect of Taurolidin on Prevention of Bloodstream Infection (Nutrilock)

This study is currently recruiting participants.
Verified April 2011 by University Hospital, Rouen
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00545831
First received: October 16, 2007
Last updated: April 20, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Sepsis
 Device: Taurolidine
Device: Physiologic Serum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Number of recurrence of catheter-related infection in each group [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: October 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Use of taurolidine in prevention of bloodstream infection related to central venous access
 Device: Taurolidine
2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
Placebo Comparator: B
Use of Physiologic Serum to compare to arm A
 Device: Physiologic Serum
2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545831

Contacts
Contact: Stéphane Lecleire, MD +33 2 32 88 81 01 stephane.lecleire@chu-rouen.fr
Contact: Julien Blot, CRA +33 2 32 88 82 65 julien.blot@chu-rouen.fr

Locations
France
APHP Beaujon Hospital Recruiting
Clichy, France
Principal Investigator: Bernard Messing, Professor            
UH of Grenoble Recruiting
Grenoble, France
Principal Investigator: Eric Fontaine, Professor            
UH of Lille Recruiting
Lille, France
Principal Investigator: Dominique Lescut, MD            
UH of Lyon Recruiting
Lyon, France
Principal Investigator: Cecile Chambrier, MD            
UH of Nice Recruiting
Nice, France
Principal Investigator: Xavier Hebuterne, Professor            
University Hospital of Rouen Recruiting
Rouen, France, 76000
Principal Investigator: Stephane Lecleire, MD            
Sub-Investigator: Eric Lerebours, Professor            
UH of Toulouse Recruiting
Toulouse, France
Principal Investigator: Jean L Bornet, MD            
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Stéphane Lecleire, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: Mr TEILLARD François, Innovation and Clinical Reserach Director, Non Applicable
ClinicalTrials.gov Identifier: NCT00545831     History of Changes
Other Study ID Numbers: 2006/100/HP, 2007-A00618-45
Study First Received: October 16, 2007
Last Updated: April 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Home Parenteral Nutrition
Sepsis Prevention
Central Venous Catheters
Taurolidine

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
 Taurolidine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 17, 2012