Effect of Taurolidin on Prevention of Bloodstream Infection

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00545831

Acronym

Nutrilock

Enrollment

Registered

2007-10-17

Start date

2007-10-31

Completion date

2011-12-31

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Home Parenteral Nutrition, Sepsis Prevention, Central Venous Catheters, Taurolidine

Brief 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.

Interventions

DEVICETaurolidine

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

DEVICEPhysiologic Serum

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Number of recurrence of catheter-related infection in each group	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026