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
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
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