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Effect of Taurolidin on Prevention of Bloodstream Infection (Nutrilock)

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00545831
First received: October 16, 2007
Last updated: March 4, 2013
Last verified: March 2013
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 ]

Enrollment: 39
Study Start Date: October 2007
Study Completion Date: December 2011
Primary Completion Date: October 2011 (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

Locations
France
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
Investigators
Principal Investigator: Stéphane Lecleire, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
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: March 4, 2013
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 June 18, 2013