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

October 16, 2007
March 4, 2013
October 2007
October 2011   (final data collection date for primary outcome measure)
Number of recurrence of catheter-related infection in each group [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Number of recurrence of catheter-related infection in each group [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00545831 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Effect of Taurolidin on Prevention of Bloodstream Infection
Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home

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.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Sepsis
  • Device: Taurolidine
    2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
  • Device: Physiologic Serum
    2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
  • Experimental: A
    Use of taurolidine in prevention of bloodstream infection related to central venous access
    Intervention: Device: Taurolidine
  • Placebo Comparator: B
    Use of Physiologic Serum to compare to arm A
    Intervention: Device: Physiologic Serum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
39
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00545831
2006/100/HP, 2007-A00618-45
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Stéphane Lecleire, MD University Hospital, Rouen
University Hospital, Rouen
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP