Central Line-associated Bloodstream Infection (CLABSI)CATERPILLARNCT05740150
Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
A study testing TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) and Heparin lock (heparin 100 IU/mL) in people with Central Line-associated Bloodstream Infection (CLABSI), run by Princess Maxima Center for Pediatric Oncology at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Central Line-associated Bloodstream Infection (CLABSI)
- What is being tested?
- TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) and Heparin lock (heparin 100 IU/mL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Oct 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Princess Máxima Center for Pediatric Oncology
Utrecht, 3511XK
Ceder van den Bosch, MSc, +31625395632, c.h.vandenbosch-4@prinsesmaximacentrum.nl
About this study
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.
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.
- Being tested
- TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL), Heparin lock (heparin 100 IU/mL)
- Keywords
- Central Line-associated Bloodstream Infection, Paediatric oncology patients, Central venous access device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)Device
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)Device
The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) | Experimental | Not described Receives: Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) |
| Heparin lock (heparin 100 IU/mL) | Active comparator | Not described Receives: Device: Heparin lock (heparin 100 IU/mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of central line associated bloodstream infections
Measured: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary outcomes (10)
Time to first central line associated bloodstream infection
Measured: 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
Measured: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of symptomatic central venous thrombosis
Measured: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of bacteraemia
Measured: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of local infections
Measured: 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
Measured: 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
Measured: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Cultured microorganisms causing central line associated bloodstream infections
Measured: 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
Measured: 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
Measured: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start27 Oct 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Line-associated Bloodstream Infection (CLABSI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Maxima Center for Pediatric Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, UMC Utrecht
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740150
- Sponsor's protocol ID
- NL2365.041.26
- Other IDs
- NTR668, 12617
- Acronym
- CATERPILLAR
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
van den Bosch CH, Loeffen Y, van der Steeg AFW, van der Bruggen JT, Frakking FNJ, Fiocco M, van de Ven CP, Wijnen MHWA, van de Wetering MD. CATERPILLAR-study protocol: an assessor-blinded randomised controlled trial comparing taurolidine-citrate-heparin to heparin-only lock solutions for the prevention of central line-associated bloodstream infections in paediatric oncology patients. BMJ Open. 2023 Mar 21;13(3):e069760. doi: 10.1136/bmjopen-2022-069760.
PubMed 36944461
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05740150
- Acronym / sponsor ID
- CATERPILLAR / NL2365.041.26
- Keywords
- Central Line-associated Bloodstream Infection, Paediatric oncology patients, Central venous access device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 462 participants (estimated)
- Lead sponsor
- Princess Maxima Center for Pediatric OncologyUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, UMC Utrecht
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) | Experimental | Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) |
| Heparin lock (heparin 100 IU/mL) | Active comparator | Device: Heparin lock (heparin 100 IU/mL) |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) |
| 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. | Device | Heparin lock (heparin 100 IU/mL) |
Primary outcome
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).
10 secondary outcomes
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).
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).
Incidence of symptomatic central venous thrombosis
Time frame: 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).
Incidence of local infections
Time frame: 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).
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Derived from this study: PubMed 36944461van den Bosch CH, Loeffen Y, van der Steeg AFW, van der Bruggen JT, Frakking FNJ, Fiocco M, van de Ven CP, Wijnen MHWA, van de Wetering MD. CATERPILLAR-study protocol: an assessor-blinded randomised controlled trial comparing taurolidine-citrate-heparin to heparin-only lock solutions for the prevention of central line-associated bloodstream infections in paediatric oncology patients. BMJ Open. 2023 Mar 21;13(3):e069760. doi: 10.1136/bmjopen-2022-069760.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) and Heparin lock (heparin 100 IU/mL) in people with Central Line-associated Bloodstream Infection (CLABSI), run by Princess Maxima Center for Pediatric Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ceder H van den Bosch, MSc (+31625395632, c.h.vandenbosch-4@prinsesmaximacentrum.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05740150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.