The AOT (Acridine Orange and Taurolidine) Trial

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00321165
First received: May 2, 2006
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

Total parenteral (intravenous) nutrition in the home setting (Home TPN or HPN) is a life saving strategy in patients who suffer from severe intestinal failure. Unfortunately, this treatment modality remains complicated by the development of frequent infectious complications. This especially relates to the device that is used to establish venous access, mostly a catheter (Hickman-Broviac type) or a port-a-cath.

Taurolodine is an antimicrobial agent without any known side effects or resistance-related problems that holds promise as an effective antibiotic lock solution to prevent catheter infections, as demonstrated recently in a pilot study in HPN patients [Jurewitsch, 2005].

In addition, recently a test has been described which may enable to confirm a suspected diagnosis of central line infection within one hour, the so-called Acridine Orange Leukocyte Cytospin test (AOLC) [Bong, 2003]. For this test, blood that is drawn from the central line is stained with the fluorescent dye acridine orange. Next, microscopic evaluation for the presence of micro-organisms takes place. Implementation of this test might enable to start treatment of the infection and prevent unnecessary removal of non-infected central lines without the necessity to several days wait for culture results.


Condition Intervention Phase
Parenteral Nutrition
Infection
Sepsis
Drug: taurolidine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The AOT (Acridine Orange and Taurolidine) Trial: a Survey on Diagnosis and Prevention of Catheter-Related Infections in Patients on Home Parenteral Nutrition

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • time between episodes of central line infection in one patient

Secondary Outcome Measures:
  • outcome of acridine orange staining test compared to culture results

Estimated Enrollment: 60
Study Start Date: June 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Two hypotheses will be tested in the AOT trial:

  1. The use of taurolidine as an antibiotic lock (5 mL) to flush the central line after infusing the TPN formulation, when compared to the present use of heparin solution (5 mL, 150 E/mL) decreases the rate of catheter-related infections in HPN patients
  2. Implementation of the acridine orange staining test allows an earlier diagnosis (or rejection of this diagnosis) compared to culture results. Importantly, in the present trial the results of this test will not be used for treatment decisions.

To this end, patients who are admitted to the clinical ward because of suspected central line infection (mostly because of fever and/or chills) will be treated according to the current protocol for catheter sepsis, after obtaining central line and peripheral blood cultures. This protocol includes the administration of medicinase through the central line and i.v. antibiotics peripherally. After obtaining informed consent, in addition 5 cc of EDTA blood will be drawn from the central line to perform (within 24 hours) the acridine orange cytospin staining test and a Gram stain. These results will than be compared to the culture results. Based on culture results, the antibiotics will be tailored.

If the patient recovers and TPN administration can be restarted, randomisation between heparin lock (5 mL, 150 E/mL) versus taurolidine lock solution 2% (5 mL) will take place. In case the catheter has to be removed because of ongoing or recurrent sepsis, randomisation takes place after a new central line has been placed and the patient continues on TPN.

A new episode of proven catheter sepsis is considered as the primary end-point.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent
  • patient on home TPN with central line (Hickman or Porth-a-cath)
  • suspected central line infection (acridine orange test)
  • proven central line infection (randomisation tauroline vs heparin)

Exclusion Criteria:

  • no informed consent
  • patient on home TPN with arteriovenous fistula (shunt)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321165

Locations
Netherlands
Department of Gastroenterology and Hepatology clinical ward
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Geert Wanten, MD, PhD Radboud University Nijmegen Medical Centre, The Netherlands
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: G.Wanten, MD, PhD, MSc, Dept of Gastroenterology and Hepatology
ClinicalTrials.gov Identifier: NCT00321165     History of Changes
Other Study ID Numbers: AOT-trial
Study First Received: May 2, 2006
Last Updated: February 10, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
nutrition
parenteral
infection
katheter
taurolidine
acridine orange
prevention

Additional relevant MeSH terms:
Infection
Communicable Diseases
Catheter-Related Infections
Taurolidine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014