Device Related InfectionNCT07587593
The IVCare Adaptive Platform Trial
A study testing Curos™, ClearGuard™ HD and Tego™ in people with Device Related Infection and Vascular Access Complication, run by The University of Queensland.
Trial summary
The IVCare trial is a multicentre adaptive platform study evaluating interventions to prevent infections and other complications associated with central venous access devices (CVADs) in patients with newly inserted or existing devices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Device Related Infection, Vascular Access Complication, Device Related Sepsis
- What is being tested?
- Curos™, ClearGuard™ HD and Tego™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Core inclusion Criteria:
- The patient has or requires a CVAD, including a PICC, a non-tunnelled or tunnelled CVC, or a totally implanted venous access port.
- Patient is less than 18 years old and paediatric recruitment has not been approved at the site.
Securement Domain exclusion criteria:
- Central line-associated bloodstream infection (CLABSI) currently suspected associated with any vascular access device (peripheral or central) that is in situ.
- CLABSI diagnosed from any vascular access device currently in situ within the past 7 days or being actively treated with antimicrobials.
- Participants with an estimated life expectancy of <30 days OR who have commenced a documented end-of-life, terminal-care, or comfort-care pathway.
- Participants who have previously been randomised for the same CVAD.
- Participants who have been randomised three times.
- SecurAcath® cannot be applied in accordance with manufacturer instructions and local policy.
- The participant has compromised skin integrity at the current or intended insertion site, including active infection, inflammation, erosion, ulceration, or pre-existing exit-site injury.
Connectors/Caps Domain exclusion criteria:
- Central line-associated bloodstream infection (CLABSI) currently suspected associated with any vascular access device (peripheral or central) that is in situ.
- CLABSI diagnosed within the past 14 days or CLABSI being actively treated with antimicrobials, associated with any vascular access device currently in situ.
- Participants with an estimated life expectancy of <30 days OR who have commenced a documented end-of-life, terminal-care, or comfort-care pathway.
- Participants who have previously been randomised for the same CVAD.
- Participants who have been randomised three times.
- Known or suspected hypersensitivity or a confirmed allergy to chlorhexidine.
Cancer stratum inclusion criteria:
- Confirmed diagnosis of a solid tumour OR
- Confirmed diagnosis of a haematological malignancy. OR
- Bone marrow failure syndrome requiring systemic therapy, immunosuppression, or haematopoietic stem cell transplantation.
Kidney stratum exclusion criteria:
- Confirmed diagnosis of kidney failure treated with haemodialysis AND
- CVAD expected to remain in place for >14 days.
About this study
Official title: Comparative Effectiveness of Interventions to Prevent Infections and Other Complications Arising From Central Venous Access Devices: the IVCare Adaptive Platform Trial.
The IVCare trial is a multicentre adaptive platform study evaluating interventions to prevent infections and other complications associated with central venous access devices (CVADs) in patients with newly inserted or existing devices. The study is organised into domains addressing different aspects of CVAD care and includes patient groups referred to as strata. Domains, strata and interventions may change over time as the study progresses. IVCare also includes an observational cohort study in which patients with CVADs are followed to assess CVAD care practices, infections, and other CVAD-related complications across health services.
The trial starts with two domains. The Connectors/Caps Domain compares antimicrobial connectors and caps with standard-of-care connectors and caps used in Australian hospitals. In the cancer stratum, participants are randomised to receive either Curos™ or standard-of-care connectors/caps. In the kidney disease stratum, participants are randomised to receive either ClearGuard™ HD or standard-of-care connectors/caps. Following a predefined stopping decision for ClearGuard™ HD in the kidney disease stratum, Tego™ will be introduced and evaluated in this group.
The Securement Domain compares the effectiveness of SecurAcath®, a subcutaneous anchor securement system, with standard-of-care securement methods used in Australian hospitals. Participants in both the cancer and kidney disease strata are randomised to receive either SecurAcath® or standard-of-care securement.
Read the detailed description
Participants who have or require a CVAD, including a peripherally inserted central catheter (PICC), non-tunnelled or tunnelled central venous catheter (CVC), or totally implanted venous access port, are eligible for the IVCare trial.
Participation in the observational cohort is a core component of trial participation and occurs for all enrolled participants. Participation in intervention domains is optional. Participants may be enrolled in more than one intervention domain concurrently.
Each domain has its own inclusion and exclusion criteria in addition to core eligibility requirements. Participants will be followed for up to 180 days from enrolment into the observational cohort or randomisation to one or more interventions.
Participants who complete follow-up in the observational cohort and/or one or more intervention domains may be eligible for re-entry, provided they meet eligibility criteria.
There is no fixed sample size for this adaptive platform trial. Recruitment into each domain will be guided by pre-specified interim analyses of accumulating data using Bayesian methods. Predefined decision rules will determine adaptations, including early stopping for futility, non-inferiority, or superiority of interventions within each domain.
- Conditions
- Device Related Infection, Vascular Access Complication, Device Related Sepsis, Catheter Infection
- Being tested
- Connectors/Caps Domain - Standard of Care, Curos™, ClearGuard™ HD, Tego™, Securement Domain - Standard of Care
- Keywords
- Central venous access device, Chlorhexidine cap, Subcutaneous anchor, Central line-associated blood stream infection, Adaptive platform trial, Disinfecting cap
- Medical subject headings
- Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connectors/Caps Domain - Standard of CareDevice
Any needle-free or closed-system connector or cap that does not contain antimicrobial agents and does not incorporate specific infection-prevention design features.
Curos™Device
Curos™ is a passive disinfecting cap intended for use with needleless connectors The cap contains 70% isopropyl alcohol. Its intended mechanism of action is to provide continuous antimicrobial protection of the connector surface between line accesses and act as a physical barrier to contamination, thereby reducing the potential for microbial transmission through the catheter hub
ClearGuard™ HDDevice
The ClearGuard™ HD cap is designed for use with haemodialysis catheters. It attaches to compatible catheter hubs to maintain a closed system between dialysis sessions. The cap is coated with chlorhexidine, which is intended to reduce microbial colonisation at the catheter hub interface.
Tego™Device
Tego™ is a needle-free capping device that closes the end of a catheter, creating a mechanically and microbiologically closed system when attached to the catheter hub.
Securement Domain - Standard of CareDevice
Basic securement using sterile tape/adhesion fixation device and a simple transparent dressing, without antimicrobial, antiseptic, or engineered stabilization features.
SecurAcath®Device
SecurAcath® is a subcutaneous catheter securement system. The device utilises a small anchor (securement feet) placed just beneath the skin at the catheter insertion site and then attached to the catheter shaft. It mechanically stabilises the catheter, reducing movement and migration.
| Study group | Role | What they receive |
|---|---|---|
| Connectors/Caps Domain - Standard of care | Active comparator | Not described Receives: Device: Connectors/Caps Domain - Standard of Care |
| Connectors/Caps Domain - Curos™ for the cancer stratum | Experimental | Not described Receives: Device: Curos™ |
| Connectors/Caps Domain - ClearGuard™ HD for the kidney stratum | Experimental | Not described Receives: Device: ClearGuard™ HD |
| Connectors/Caps Domain - Tego™ for the kidney stratum | Experimental | Not described Receives: Device: Tego™ |
| Securement Domain - Standard of care | Active comparator | Not described Receives: Device: Securement Domain - Standard of Care |
| Securement Domain - SecurAcath® | Experimental | Not described Receives: Device: SecurAcath® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Line-Associated Bloodstream Infection (CLABSI)
Laboratory confirmed bloodstream infection associated with the study central venous access device (CVAD), with no other source for the infection, consistent with core criteria of the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) from January 2026
Measured: Up to 180 days
Secondary outcomes (12)
Positive blood cultures
Any positive blood culture classified as contaminant, CLABSI, non-CLABSI primary bloodstream infection, mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), or secondary bloodstream infection, consistent with the CDC NHSN criteria from January 2026
Measured: Up to 180 days
Catheter-related infection
Catheter-related infection consistent with the Catheter Related Infection definitions (CRI1, CRI2, and CRI3) from the European Centre for Disease Prevention and Control (ECDC) version 1.02 from 2015
Measured: 180 days
Central Venous Catheter (CVC) exit site infection
CVC exit site infection consistent with the Infectious Diseases Society of America (IDSA) guidelines from 2009
Measured: Up to 180 days
Pocket site infection
Pocket site infection consistent with the IDSA guidelines from 2009
Measured: Up to 180 days
CVAD failure
CVAD failure defined as a composite measure of CLABSI and any other infectious or non-infectious complication leading to CVAD removal.
Measured: Up to 180 days
CVAD complications not requiring removal
CVAD complications not requiring removal, defined as a composite measure of any complication not requiring CVAD removal.
Measured: Up to 180 days
CVAD insertion complications
CVAD insertion complications, defined as a composite measure of any insertion complications.
Measured: Up to 180 days
Health-related quality of life
Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Measured: Up to 180 days
Patients' experiences of care
Assessed using the Australian Hospital Patient Experience Question Set (AHPEQS)
Measured: Up to 180 days
CVAD-related Serious Adverse Events (SAEs)
Any SAE considered related or possible related to the CVAD.
Measured: Up to 180 days
Intervention-related SAEs
Any SAE considered related or possibly related to an intervention within the Connectors/Caps or the Securement domain.
Measured: Up to 180 days
Unanticipated Serious Adverse Device Effect (USADEs)
Any SAE which meets the definition of an USADE.
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device Related InfectionStudies 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
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Bayside Health, Monash Medical Centre, Princess Alexandra Hospital, Brisbane, Australia, Liverpool Hospital, South Western Sydney Local Health District, Royal Brisbane and Women's Hospital, Royal North Shore Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587593
- Sponsor's protocol ID
- IPVA_26_01
- Status last verified
- Jul 2026
- First submitted
- 7 May 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Interventions to Prevent Infections and Other Complications Arising From Central Venous Access Devices: the IVCare Adaptive Platform Trial.
- ClinicalTrials.gov ID
- NCT07587593
- Acronym / sponsor ID
- IPVA_26_01
- Conditions
- Device Related Infection, Vascular Access Complication, Device Related Sepsis, Catheter Infection
- Keywords
- Central venous access device, Chlorhexidine cap, Subcutaneous anchor, Central line-associated blood stream infection, Adaptive platform trial, Disinfecting cap
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Bayside Health, Monash Medical Centre, Princess Alexandra Hospital, Brisbane, Australia, Liverpool Hospital, South Western Sydney Local Health District, Royal Brisbane and Women's Hospital, Royal North Shore Hospital
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 14 May 2026 (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 IVCare trial is a multicentre adaptive platform study evaluating interventions to prevent infections and other complications associated with central venous access devices (CVADs) in patients with newly inserted or existing devices. The study is organised into domains addressing different aspects of CVAD care and includes patient groups referred to as strata. Domains, strata and interventions may change over time as the study progresses. IVCare also includes an observational cohort study in which patients with CVADs are followed to assess CVAD care practices, infections, and other CVAD-related complications across health services.
The trial starts with two domains. The Connectors/Caps Domain compares antimicrobial connectors and caps with standard-of-care connectors and caps used in Australian hospitals. In the cancer stratum, participants are randomised to receive either Curos™ or standard-of-care connectors/caps. In the kidney disease stratum, participants are randomised to receive either ClearGuard™ HD or standard-of-care connectors/caps. Following a predefined stopping decision for ClearGuard™ HD in the kidney disease stratum, Tego™ will be introduced and evaluated in this group.
The Securement Domain compares the effectiveness of SecurAcath®, a subcutaneous anchor securement system, with standard-of-care securement methods used in Australian hospitals. Participants in both the cancer and kidney disease strata are randomised to receive either SecurAcath® or standard-of-care securement.
Detailed description
Participants who have or require a CVAD, including a peripherally inserted central catheter (PICC), non-tunnelled or tunnelled central venous catheter (CVC), or totally implanted venous access port, are eligible for the IVCare trial.
Participation in the observational cohort is a core component of trial participation and occurs for all enrolled participants. Participation in intervention domains is optional. Participants may be enrolled in more than one intervention domain concurrently.
Each domain has its own inclusion and exclusion criteria in addition to core eligibility requirements. Participants will be followed for up to 180 days from enrolment into the observational cohort or randomisation to one or more interventions.
Participants who complete follow-up in the observational cohort and/or one or more intervention domains may be eligible for re-entry, provided they meet eligibility criteria.
There is no fixed sample size for this adaptive platform trial. Recruitment into each domain will be guided by pre-specified interim analyses of accumulating data using Bayesian methods. Predefined decision rules will determine adaptations, including early stopping for futility, non-inferiority, or superiority of interventions within each domain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Connectors/Caps Domain - Standard of care | Active comparator | Device: Connectors/Caps Domain - Standard of Care |
| Connectors/Caps Domain - Curos™ for the cancer stratum | Experimental | Device: Curos™ |
| Connectors/Caps Domain - ClearGuard™ HD for the kidney stratum | Experimental | Device: ClearGuard™ HD |
| Connectors/Caps Domain - Tego™ for the kidney stratum | Experimental | Device: Tego™ |
| Securement Domain - Standard of care | Active comparator | Device: Securement Domain - Standard of Care |
| Securement Domain - SecurAcath® | Experimental | Device: SecurAcath® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Connectors/Caps Domain - Standard of CareAny needle-free or closed-system connector or cap that does not contain antimicrobial agents and does not incorporate specific infection-prevention design features. | Device | Connectors/Caps Domain - Standard of care |
| Curos™Curos™ is a passive disinfecting cap intended for use with needleless connectors The cap contains 70% isopropyl alcohol. Its intended mechanism of action is to provide continuous antimicrobial protection of the connector surface between line accesses and act as a physical barrier to contamination, thereby reducing the potential for microbial transmission through the catheter hub | Device | Connectors/Caps Domain - Curos™ for the cancer stratum |
| ClearGuard™ HDThe ClearGuard™ HD cap is designed for use with haemodialysis catheters. It attaches to compatible catheter hubs to maintain a closed system between dialysis sessions. The cap is coated with chlorhexidine, which is intended to reduce microbial colonisation at the catheter hub interface. | Device | Connectors/Caps Domain - ClearGuard™ HD for the kidney stratum |
| Tego™Tego™ is a needle-free capping device that closes the end of a catheter, creating a mechanically and microbiologically closed system when attached to the catheter hub. | Device | Connectors/Caps Domain - Tego™ for the kidney stratum |
| Securement Domain - Standard of CareBasic securement using sterile tape/adhesion fixation device and a simple transparent dressing, without antimicrobial, antiseptic, or engineered stabilization features. | Device | Securement Domain - Standard of care |
| SecurAcath®SecurAcath® is a subcutaneous catheter securement system. The device utilises a small anchor (securement feet) placed just beneath the skin at the catheter insertion site and then attached to the catheter shaft. It mechanically stabilises the catheter, reducing movement and migration. | Device | Securement Domain - SecurAcath® |
Primary outcome
Central Line-Associated Bloodstream Infection (CLABSI)
Time frame: Up to 180 days
Laboratory confirmed bloodstream infection associated with the study central venous access device (CVAD), with no other source for the infection, consistent with core criteria of the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) from January 2026
12 secondary outcomes
Positive blood cultures
Time frame: Up to 180 days
Catheter-related infection
Time frame: 180 days
Central Venous Catheter (CVC) exit site infection
Time frame: Up to 180 days
Pocket site infection
Time frame: Up to 180 days
CVAD failure
Time frame: Up to 180 days
CVAD complications not requiring removal
Time frame: Up to 180 days
CVAD insertion complications
Time frame: Up to 180 days
Health-related quality of life
Time frame: Up to 180 days
Patients' experiences of care
Time frame: Up to 180 days
CVAD-related Serious Adverse Events (SAEs)
Time frame: Up to 180 days
Intervention-related SAEs
Time frame: Up to 180 days
Unanticipated Serious Adverse Device Effect (USADEs)
Time frame: Up to 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Curos™, ClearGuard™ HD and Tego™ in people with Device Related Infection and Vascular Access Complication, run by The University of Queensland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Line-Associated Bloodstream Infection (CLABSI) (time frame: Up to 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.