Antibiotic-lock technique with Taurolidine for prevention of central venous catheter infection in neutropenic patients
| ISRCTN | ISRCTN47102251 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47102251 |
| Secondary identifying numbers | PI13/01474 |
- Submission date
- 09/09/2015
- Registration date
- 21/10/2015
- Last edited
- 25/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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 September 2018
Who is funding the study?
The Carlos III Health Institute (Spain)
Who is the main contact?
Dr Carlota Gudiol
Contact information
Scientific
Infectious Disease Department
Hospital Universitari de Bellvitge
Feixa Llarga s/n
Hospitalet de Llobregat
Bracelona
08907
Spain
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Antibiotic-lock technique with Taurolidine for prevention of central venous catheter infection in neutropenic patients: a randomized, double-blind, placebo-controlled study |
| Study acronym | TAURCAT |
| Study objectives | 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(s) | Ethics Committee of the Hospital Universitari de Bellvitge (Comité Ètic d'Investigació Clínica), 06/06/2013, ref: AC019/13 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Taurolidine |
| Primary outcome measure | 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 study start date | 01/01/2013 |
| Completion date | 19/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/10/2013 |
| Date of final enrolment | 19/04/2018 |
Locations
Countries of recruitment
- Spain
Study participating centres
L'Hospitalet de Llobregat
Barcelona
08907
Spain
L'Hospitalet de Llobregat
Barcelona
08908
Spain
Sponsor information
Research organisation
Sinesio Delagado 4
Madrid
28029
Spain
| Phone | + 34 (0)91 822 20 00 |
|---|---|
| oficina.informacion@isciii.es | |
| Website | http://www.isciii.es |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Hospital/treatment centre
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Authors of the study will try to publish the results of the trial in a high impact factor scientific journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/05/2018 | Yes | No | |
| Results article | results | 27/01/2020 | 25/02/2021 | Yes | No |
Editorial Notes
25/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
14/11/2019: The intention to publish date has been changed from 19/05/2019 to 31/12/2019.
07/06/2018: The following changes have been made to the trial record:
1. The overall trial end date was changed from 30/09/2018 to 19/05/2018
2. The intention to publish date was changed from 31/12/2018 to 19/05/2019
11/05/2018: The recruitment end date was changed from 30/06/2018 to 19/04/2018.
04/05/2018: Publication reference added.
15/03/2018: The following updates were made:
1. Recruitment end date was changed from 31/12/2016 to 30/06/2018.
2. Overall trial end date was changed from 31/12/2017 to 30/09/2018.
