Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%

NCT01826526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2016-12-06

No results posted yet for this study

Summary

The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream infections in patients with home parenteral nutrition.

Conditions

  • Catheter Related Blood Stream Infections

Interventions

DEVICE

TauroSept®

5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily. The duration of TauroSept® administration in this trial will be 12 months.

Sponsors & Collaborators

  • Geistlich Pharma AG

    collaborator INDUSTRY
  • Geert Wanten

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-09-30
Completion
2016-11-30

Countries

  • Denmark
  • Germany
  • Israel
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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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 NCT01826526 on ClinicalTrials.gov