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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47102251
Enrollment
150
Registered
2015-10-21
Start date
2013-10-15
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Catheter infection 2. Catheter-related bacteremia Infections and Infestations 1. Catheter infection 2. Catheter-related bacteremia

Interventions

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 anti

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026