The IVCare Adaptive Platform Trial

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.

• Connectors/Caps Domain - Standard of Care (Device): 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™ HD (Device): 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 Care (Device): 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.

Primary outcomes

• Central Line-Associated Bloodstream Infection (CLABSI) [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

Secondary outcomes

• Positive blood cultures [Up to 180 days]: 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
• Catheter-related infection [180 days]: 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
• Central Venous Catheter (CVC) exit site infection [Up to 180 days]: CVC exit site infection consistent with the Infectious Diseases Society of America (IDSA) guidelines from 2009
• Pocket site infection [Up to 180 days]: Pocket site infection consistent with the IDSA guidelines from 2009
• CVAD failure [Up to 180 days]: CVAD failure defined as a composite measure of CLABSI and any other infectious or non-infectious complication leading to CVAD removal.
• CVAD complications not requiring removal [Up to 180 days]: CVAD complications not requiring removal, defined as a composite measure of any complication not requiring CVAD removal.
• CVAD insertion complications [Up to 180 days]: CVAD insertion complications, defined as a composite measure of any insertion complications.
• Health-related quality of life [Up to 180 days]: Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
• Patients' experiences of care [Up to 180 days]: Assessed using the Australian Hospital Patient Experience Question Set (AHPEQS)
• CVAD-related Serious Adverse Events (SAEs) [Up to 180 days]: Any SAE considered related or possible related to the CVAD.
• Intervention-related SAEs [Up to 180 days]: Any SAE considered related or possibly related to an intervention within the Connectors/Caps or the Securement domain.
• Unanticipated Serious Adverse Device Effect (USADEs) [Up to 180 days]: Any SAE which meets the definition of an USADE.

Sex: All

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.