Effect of Taurolidin on Prevention of Bloodstream Infection

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Device: Taurolidine
* Device: Physiologic Serum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Use of taurolidine in prevention of bloodstream infection related to central venous access | Device: Taurolidine<br>* 2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months<br>|
| Placebo Comparator: B<br>Use of Physiologic Serum to compare to arm A | Device: Physiologic Serum<br>* 2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of recurrence of catheter-related infection in each group |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Parenteral Nutrition, Sepsis Prevention, Central Venous Catheters, Taurolidine