Effect of Taurolidin on Prevention of Bloodstream Infection (Nutrilock)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00545831
Recruitment Status : Terminated (lack of recruitment)
First Posted : October 17, 2007
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sepsis Device: Taurolidine Device: Physiologic Serum Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of recurrence of catheter-related infection in each group [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00545831

APHP Beaujon Hospital
Clichy, France
UH of Grenoble
Grenoble, France
UH of Lille
Lille, France
UH of Lyon
Lyon, France
UH of Nice
Nice, France
University Hospital of Rouen
Rouen, France, 76000
UH of Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Stéphane Lecleire, MD University Hospital, Rouen

Responsible Party: University Hospital, Rouen Identifier: NCT00545831     History of Changes
Other Study ID Numbers: 2006/100/HP
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents