Effect of Taurolidin on Prevention of Bloodstream Infection

Sepsis Clinical Trial

— Nutrilock  

Official title:

Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00545831
• Other study ID #: 2006/100/HP
• Secondary ID: 2007-A00618-45
• Status: Terminated
• Phase: N/A
• First received: October 16, 2007
• Last updated: March 4, 2013
• Start date: October 2007
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sepsis

Intervention

Device:
• Taurolidine
2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
• Physiologic Serum
2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months

Locations

Country	Name	City	State
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	UH of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of recurrence of catheter-related infection in each group		6 months	Yes