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Effect of Taurolidin on Prevention of Bloodstream Infection

NCT00545831 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2013-03-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Stéphane Lecleire, MD · University Hospital, Rouen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00545831 on ClinicalTrials.gov