Effect of Taurolidin on Prevention of Bloodstream Infection

NCT00545831 | Terminated

• 2 other identifiers: 2006/100/HP2007-A00618-45
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 7

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.

Conditions

Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of recurrence of catheter-related infection in each group

  6 months

Study Arms (2)

A

EXPERIMENTAL

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

Device: Taurolidine

B

PLACEBO COMPARATOR

Use of Physiologic Serum to compare to arm A

Device: Physiologic Serum

Interventions

Taurolidine DEVICE

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

A

Physiologic Serum DEVICE

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

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (7)

APHP Beaujon Hospital

Clichy, France

Location

UH of Grenoble

Grenoble, France

Location

UH of Lille

Lille, France

Location

UH of Lyon

Lyon, France

Location

UH of Nice

Nice, France

Location

University Hospital of Rouen

Rouen, 76000, France

Location

UH of Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane Lecleire, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

FR (7)