Antibiotic-lock technique with Taurolidine for prevention of central venous catheter infection in neutropenic patients

Not Applicable

Completed

• Conditions: 1. Catheter infection 2. Catheter-related bacteremia; Infections and Infestations

• Registration Number: ISRCTN47102251
• Lead Sponsor: The Carlos III Health Institute (Instituto de Salud Carlos III)

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29720244 2020 results in https://pubmed.ncbi.nlm.nih.gov/31712211/ (added 25/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-21
• Study Completion: 2018-05-19
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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