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

Central Line-associated Bloodstream Infection (CLABSI) Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740150
• Other study ID #: NL2365.041.26
• Secondary ID: NTR66812617
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Princess Maxima Center for Pediatric Oncology
• Contact: Ceder H van den Bosch, MSc
• Phone: +31625395632
• Email: c.h.vandenbosch-4[@]prinsesmaximacentrum.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 462
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Line-associated Bloodstream Infection (CLABSI)
• Communicable Diseases
• Infections
• Sepsis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Princess Máxima Center for Pediatric Oncology	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
Princess Maxima Center for Pediatric Oncology	Dutch Cancer Society, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of central line associated bloodstream infections		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Time to first central line associated bloodstream infection		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Central line associated bloodstream infection incidence per 1,000 central venous access device-days		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Incidence of symptomatic central venous thrombosis		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Incidence of bacteraemia		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Incidence of local infections		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Incidence of and reasons for central venous access device-removal		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Cultured microorganisms causing central line associated bloodstream infections		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis		From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary	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		From central venous access device insertion until the end of follow-up (maximum of 90 days).