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

February 13, 2023 updated by: Princess Maxima Center for Pediatric Oncology

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

462

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
Active Comparator: Heparin lock (heparin 100 IU/mL)
Device: Heparin lock (heparin 100 IU/mL)
The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
From central venous access device insertion until the end of follow-up (maximum of 90 days).

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
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).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of symptomatic central venous thrombosis
Time Frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of bacteraemia
Time Frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of local infections
Time Frame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
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).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
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).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
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).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
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).
From central venous access device insertion until the end of follow-up (maximum of 90 days).
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).
From central venous access device insertion until the end of follow-up (maximum of 90 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Maxima Center for Pediatric Oncology

Collaborators

UMC Utrecht
Dutch Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Estimate)

February 22, 2023

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL2365.041.26
  • NTR668 (Registry Identifier: Nederlands Trial Register)
  • 12617 (Other Grant/Funding Number: Dutch Cancer Society)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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