Parenteral NutritionPhase 3NCT00321165
The AOT (Acridine Orange and Taurolidine) Trial
A Phase 3 study testing taurolidine in people with Parenteral Nutrition and Infection, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition, Infection, Sepsis
- What is being tested?
- taurolidine
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2006to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- no informed consent
- patient on home TPN with arteriovenous fistula (shunt)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Gastroenterology and Hepatology clinical ward
Nijmegen, 6500 HB
About this study
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
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.
Read the detailed description
Two hypotheses will be tested in the AOT trial:
- 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
- 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.
- Conditions
- Parenteral Nutrition, Infection, Sepsis
- Being tested
- taurolidine
- Keywords
- nutrition, parenteral, infection, katheter, taurolidine, acridine orange, prevention
- Medical subject headings
- Hyperphagia, Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taurolidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
time between episodes of central line infection in one patient
Secondary outcomes (1)
outcome of acridine orange staining test compared to culture results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Geert Wanten, MD, PhD, Principal investigator, Radboud University Nijmegen Medical Centre, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321165
- Sponsor's protocol ID
- AOT-trial
- Status last verified
- Feb 2009
- First submitted
- 2 May 2006
- Last updated
- 11 Feb 2009
- Results posted
- No
Publications
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.
PubMed 15896434Bong 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.
PubMed 12665171Bisseling 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.
PubMed 20061070
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00321165
- Acronym / sponsor ID
- AOT-trial
- Conditions
- Parenteral Nutrition, Infection, Sepsis
- Keywords
- nutrition, parenteral, infection, katheter, taurolidine, acridine orange, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two hypotheses will be tested in the AOT trial:
- 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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- no informed consent
- patient on home TPN with arteriovenous fistula (shunt)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taurolidine | Drug | – |
Primary outcome
time between episodes of central line infection in one patient
1 secondary outcome
outcome of acridine orange staining test compared to culture results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2009.
- Background: PubMed 15896434Jurewitsch 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.
- Background: PubMed 12665171Bong 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.
- Derived from this study: PubMed 20061070Bisseling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Wanten, MD, PhD principal investigator
Radboud University Nijmegen Medical Centre, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing taurolidine in people with Parenteral Nutrition and Infection, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time between episodes of central line infection in one patient. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00321165, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2009.