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Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients. (CATERPILLAR)

Primary Purpose

Central Line-associated Bloodstream Infection (CLABSI)

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
Heparin lock (heparin 100 IU/mL)
Sponsored by
Princess Maxima Center for Pediatric Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Central Line-associated Bloodstream Infection (CLABSI) focused on measuring Central Line-associated Bloodstream Infection, Paediatric oncology patients, Central venous access device

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 0 - <19 years Radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies) Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Center for Pediatric Oncology Planned central venous access device insertion of >90 days Written consent signed according to local law and regulations Parents/guardians or patient are willing and able to comply with the trial procedure Exclusion Criteria: A previous central venous access device removed < 12 months ago. Expected treatment for a majority of the follow-up time in a different hospital than the Princess Maxima Center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Center at least once every 3 weeks. Primary immunological disorder Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia. Documented bacteremia in the period from 24h before catheter insertion until inclusion

Sites / Locations

  • Princess Máxima Center for Pediatric OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)

Heparin lock (heparin 100 IU/mL)

Arm Description

Outcomes

Primary Outcome Measures

Incidence of central line associated bloodstream infections

Secondary Outcome Measures

Time to first central line associated bloodstream infection
Central line associated bloodstream infection incidence per 1,000 central venous access device-days
Incidence of symptomatic central venous thrombosis
Incidence of bacteraemia
Incidence of local infections
Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis
Incidence of and reasons for central venous access device-removal
Cultured microorganisms causing central line associated bloodstream infections
Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis
Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis

Full Information

First Posted
February 2, 2023
Last Updated
February 13, 2023
Sponsor
Princess Maxima Center for Pediatric Oncology
Collaborators
Dutch Cancer Society, UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT05740150
Brief Title
Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
Acronym
CATERPILLAR
Official Title
The Efficacy of a Lock Solution Containing Taurolidine, Citrate and Heparin for the Prevention of Tunneled Central Line-associated Bloodstream Infections in Pediatric Oncology Patients, a Randomized Controlled, Mono-center Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Princess Maxima Center for Pediatric Oncology
Collaborators
Dutch Cancer Society, UMC Utrecht

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Line-associated Bloodstream Infection (CLABSI)
Keywords
Central Line-associated Bloodstream Infection, Paediatric oncology patients, Central venous access device

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
462 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
Arm Type
Experimental
Arm Title
Heparin lock (heparin 100 IU/mL)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
Intervention Description
The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
Intervention Type
Device
Intervention Name(s)
Heparin lock (heparin 100 IU/mL)
Intervention Description
The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
Primary Outcome Measure Information:
Title
Incidence of central line associated bloodstream infections
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary Outcome Measure Information:
Title
Time to first central line associated bloodstream infection
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Central line associated bloodstream infection incidence per 1,000 central venous access device-days
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Incidence of symptomatic central venous thrombosis
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Incidence of bacteraemia
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Incidence of local infections
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Incidence of and reasons for central venous access device-removal
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Cultured microorganisms causing central line associated bloodstream infections
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Title
Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis
Time Frame
From central venous access device insertion until the end of follow-up (maximum of 90 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 0 - <19 years Radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies) Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Center for Pediatric Oncology Planned central venous access device insertion of >90 days Written consent signed according to local law and regulations Parents/guardians or patient are willing and able to comply with the trial procedure Exclusion Criteria: A previous central venous access device removed < 12 months ago. Expected treatment for a majority of the follow-up time in a different hospital than the Princess Maxima Center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Center at least once every 3 weeks. Primary immunological disorder Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia. Documented bacteremia in the period from 24h before catheter insertion until inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ceder H van den Bosch, MSc
Phone
+31625395632
Email
c.h.vandenbosch-4@prinsesmaximacentrum.nl
Facility Information:
Facility Name
Princess Máxima Center for Pediatric Oncology
City
Utrecht
ZIP/Postal Code
3511XK
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ceder van den Bosch, MSc
Phone
+31625395632
Email
c.h.vandenbosch-4@prinsesmaximacentrum.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The results of this trial will be published in an open access peer-reviewed journal, presented at international congresses and subsequently the data (stored for at least 15 years) will be made available after publication of the main results manuscript upon reasonable requests. The patient society (Vereniging Kinderkanker Nederland) will be involved in the plan for the dissemination of the trial results to the participants and public after completion of the trial.
IPD Sharing Time Frame
Before the end of the study the study protocol, statistical analysis plan and informed consent forms will be published in a peer-reviewed journal. The results of this trial will be published in an open access peer-reviewed journal, presented at international congresses and subsequently the data (stored for at least 15 years) will be made available after publication of the main results manuscript upon reasonable requests. The patient society (Vereniging Kinderkanker Nederland) will be involved in the plan for the dissemination of the trial results to the participants and public after completion of the trial.

Learn more about this trial

Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.

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