The AOT (Acridine Orange and Taurolidine) Trial

NCT00321165 | Completed Phase 3

• 1 other identifier: AOT-trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parenteral Nutrition; Infection; Sepsis

Keywords

nutrition; parenteral; infection; katheter; taurolidine; acridine orange; prevention

Outcome Measures

Primary Outcomes (1)

• time between episodes of central line infection in one patient

Secondary Outcomes (1)

• outcome of acridine orange staining test compared to culture results

Interventions

taurolidine DRUG

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• no informed consent
• patient on home TPN with arteriovenous fistula (shunt)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Department of Gastroenterology and Hepatology clinical ward

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (3)

• Jurewitsch B, Jeejeebhoy KN. Taurolidine lock: the key to prevention of recurrent catheter-related bloodstream infections. Clin Nutr. 2005 Jun;24(3):462-5. doi: 10.1016/j.clnu.2005.02.001. Epub 2005 Apr 22.

  PMID: 15896434 BACKGROUND

• Bong JJ, Kite P, Ammori BJ, Wilcox MH, McMahon MJ. The use of a rapid in situ test in the detection of central venous catheter-related bloodstream infection: a prospective study. JPEN J Parenter Enteral Nutr. 2003 Mar-Apr;27(2):146-50. doi: 10.1177/0148607103027002146.

  PMID: 12665171 BACKGROUND

• Bisseling TM, Willems MC, Versleijen MW, Hendriks JC, Vissers RK, Wanten GJ. Taurolidine lock is highly effective in preventing catheter-related bloodstream infections in patients on home parenteral nutrition: a heparin-controlled prospective trial. Clin Nutr. 2010 Aug;29(4):464-8. doi: 10.1016/j.clnu.2009.12.005. Epub 2010 Jan 12.

  PMID: 20061070 DERIVED

MeSH Terms

Conditions

Hyperphagia; Infections; Sepsis

Interventions

taurolidine

Condition Hierarchy (Ancestors)

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

Study Officials

• Geert Wanten, MD, PhD

  Radboud University Nijmegen Medical Centre, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2006
• First Posted: May 3, 2006
• Study Start: June 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 11, 2009

Record last verified: 2009-02

Locations

NL (1)