Condition category
Infections and Infestations
Date applied
09/09/2015
Date assigned
21/10/2015
Last edited
02/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A central venous catheter (CVC) is a long, thin tube that is inserted into the major vein in the neck (jugular vein), chest (subclavian vein or axillary vein) or groin (femoral vein). CVC’s are considered to be one of the best ways to give long-term medicine treatment, such as chemotherapy. The use of CVC’s has increased considerably in recent years and catheter-related bloodstream infections (CR-BSI) have become a recurrent complication. These infections can cause seriously ill patients with CVC’s to become even more ill or even die. A good way of preventing these infections is by “flushing” the tube with an antibacterial solution, which helps to create a barrier at the catheter site so that harmful bacteria cannot get into the blood (catheter lock solution). This is especially important for patients who have low levels of certain white blood cells in their blood (neutropenia), and are therefore more susceptible to infections. Taurolidine-citrate is an antibiotic which has been shown to be very effective in fighting CR-BSI’s when used as a catheter lock solution. The aim of this study is to see whether using a Tautolidine-lock solution is an effective way of preventing CR-BSI’s in neutropenic patients.

Who can participate?
Adults in hospital, who have a central venous catheter and are likely to develop neutropenia lasting for more than one week.

What does the study involve?
Participants are randomly allocated into one of two groups. The first group (intervention group) is given a 2.5ml solution of 2% Taurolidine-citrate three times a week, and the second group (control group) is given heparin (acting as a placebo as it has no effect on the infection) three times a week. The solution is left in place for one hour (antibiotic-lock technique) for one hour, before it is aspirated (sucked away) with a syringe. Treatment continues until patient recovers from neutropenia; when the catheter needs to be used for continuous medicine treatment; or when the patient dies. Levels of infection at the catheter site or in the blood, throughout the study.

What are the possible benefits and risks of participating?
There are no benefits or risks of participating in this trial.

Where is the study run from?
1. Hospital Universitari de Bellvitge (Spain)
2. Duran i Reynals Hospital – Catalan Institute of Oncology (Spain)

When is the study starting and how long is it expected to run for?
January 2013 to December 2017

Who is funding the study?
The Carlos III Health Institute (Spain)

Who is the main contact?
Dr Carlota Gudiol

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carlota Gudiol

ORCID ID

Contact details

Infectious Disease Department
Hospital Universitari de Bellvitge
Feixa Llarga s/n
Hospitalet de Llobregat
Bracelona
08907
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI13/01474

Study information

Scientific title

Antibiotic-lock technique with Taurolidine for prevention of central venous catheter infection in neutropenic patients: a randomized, double-blind, placebo-controlled study

Acronym

TAURCAT

Study hypothesis

Antibiotic-lock technique with Taurolidine would be effective and safe in preventing the bacterial colonization of the central venous catheters in neutropenic patients.

Ethics approval

Ethics Committee of the Hospital Universitari de Bellvitge (Comité Ètic d'Investigació Clínica), 06/06/2013, ref: AC019/13

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

1. Catheter infection
2. Catheter-related bacteremia

Intervention

Patients will be randomly assigned to undergo antibiotic-lock technique of the central venous catheter with Taurolidine 3 times a week or with heparin (placebo), during the neutropenic phase. The antibiotic-lock technique of the catheters in both arms will be stopped when the neutrophil count recovers above 500 micro-liters, when the catheter needs to be removed for any reason, when an episode of catheter-related bacteremia occurs, when the catheter needs to be used with a continuous infusion or when the patient dies.

Intervention type

Drug

Phase

Not Applicable

Drug names

Taurolidine

Primary outcome measures

Bacterial colonization of at least one of the three hubs of the central venous catheter, measured by the detection of bacterial growth in the hubs, which are cultured 3 times a week, until the end of the intervention.

Secondary outcome measures

1. Incidence of catheter-related bacteraemia, measured daily throughout the intervention, using blood cultures when the patient has fever
2. The number of cases where the venous catheter has to be removed for any reason, monitored throughout the intervention period
3. Overall mortality is measured during the intervention period and for 30 days after the end of the intervention in both treatment groups

Overall trial start date

01/01/2013

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients aged > 18 years
2. Hospitalized with leukemia, lymphoma or stem cell transplantation
3. Carry a central venous catheter
4. Likely to develop neutropenia (<500 neutrophils per ul) lasting more than one week

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Patients with a (not flexible) semi-rigid central venous catheter
2. Patients who have been found to have a positive culture of the hubs or the insertion site of the catheter, previously to randomization
3. Patients in whom the central venous catheter is used for parenteral nutrition or medication that needs continuous infusion
4. Patients receiving systemic antibiotic treatment ≥ 48 hours
5. Patients who have an active infection at the baseline statement

Recruitment start date

15/10/2013

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitari de Bellvitge
Feixa Llarga L'Hospitalet de Llobregat
Barcelona
08907
Spain

Trial participating centre

Duran i Reynals Hospital – Catalan Institute of Oncology
Gran Via 199-203 L'Hospitalet de Llobregat
Barcelona
08908
Spain

Sponsor information

Organisation

The Carlos III Health Institute (Instituto de Salud Carlos III)

Sponsor details

Sinesio Delagado 4
Madrid
28029
Spain
+ 34 91 822 20 00
oficina.informacion@isciii.es

Sponsor type

Research organisation

Website

http://www.isciii.es

Funders

Funder type

Hospital/treatment centre

Funder name

The Carlos III Health Institute (Instituto de Salud Carlos III)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Authors of the study will try to publish the results of the trial in a high impact factor scientific journal.

Intention to publish date

31/12/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes