Effect of Taurolidin on Prevention of Bloodstream Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-12-31

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.

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Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

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

Group Type EXPERIMENTAL

Taurolidine

Intervention Type DEVICE

2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months

B

Use of Physiologic Serum to compare to arm A

Group Type PLACEBO_COMPARATOR

Physiologic Serum

Intervention Type DEVICE

2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months

Interventions

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Taurolidine

2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months

Intervention Type DEVICE

Physiologic Serum

2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No