Effect of Taurolidin on Prevention of Bloodstream Infection (Nutrilock)

University Hospital, Rouen

Status: Terminated

Conditions: Sepsis

Treatments: Device: Taurolidine; Device: Physiologic Serum

Study type: Interventional

Funder types: Other

Identifiers

NCT00545831

2006/100/HP

2007-A00618-45

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

39 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Use of taurolidine in prevention of bloodstream infection related to central venous access

Treatment:

Device: Taurolidine

B

Placebo Comparator group

Description:

Use of Physiologic Serum to compare to arm A

Treatment:

Device: Physiologic Serum