NCT00545831

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2007-10-17
• Last updated: 2013-03-05

Locations

7 sites across 1 country: France