The IVCare Adaptive Platform Trial

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 chlorhexidine-containing connectors and caps with standard-of-care connectors and caps used in Australian hospitals. In the cancer stratum, participants are randomised to receive either InVision-Plus CS® 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Catheter Infection; Vascular Access Complication; Device Related Infection; Device Related Sepsis
• Intervention / Treatment: Device: Connectors/Caps Domain - Standard of Care; Device: InVision-Plus CS®; Device: ClearGuard™ HD; Device: Tego™; Device: Securement Domain - Standard of Care; Device: SecurAcath®

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 Type: Interventional
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 or silver-containing products.

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 disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Connectors/Caps Domain - Standard of care	Device: Connectors/Caps Domain - Standard of Care; Any needle-free or closed-system connector or cap that does not contain antimicrobial agents and does not incorporate specific infection-prevention design features.
Experimental: Connectors/Caps Domain - InVision-Plus CS® for the cancer stratum	Device: InVision-Plus CS®; InVision-Plus CS® is a needleless intravenous (IV) connector system intended for use in IV and blood administration sets without the use of needles, thereby reducing the risk of needle-stick injuries during use. The device incorporates antimicrobial agents, including silver and chlorhexidine, designed to reduce microbial colonisation on treated surfaces, including the septum and fluid path.
Experimental: Connectors/Caps Domain - ClearGuard™ HD for the kidney stratum	Device: ClearGuard™ HD; 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.
Experimental: Connectors/Caps Domain - Tego™ for the kidney stratum	Device: 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.
Active Comparator: Securement Domain - Standard of care	Device: Securement Domain - Standard of Care; Basic securement using sterile tape/adhesion fixation device and a simple transparent dressing, without antimicrobial, antiseptic, or engineered stabilization features.
Experimental: Securement Domain - SecurAcath®	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Up to 180 days
Pocket site infection	Pocket site infection consistent with the IDSA guidelines from 2009	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.	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.	Up to 180 days
CVAD insertion complications	CVAD insertion complications, defined as a composite measure of any insertion complications.	Up to 180 days
Health-related quality of life	Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire	Up to 180 days
Patients' experiences of care	Assessed using the Australian Hospital Patient Experience Question Set (AHPEQS)	Up to 180 days
CVAD-related Serious Adverse Events (SAEs)	Any SAE considered related or possible related to the CVAD.	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.	Up to 180 days
Unanticipated Serious Adverse Device Effect (USADEs)	Any SAE which meets the definition of an USADE.	Up to 180 days

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: Bayside Health; Royal Brisbane and Women's Hospital; Princess Alexandra Hospital, Brisbane, Australia; Royal North Shore Hospital; Monash Medical Centre; Liverpool Hospital, South Western Sydney Local Health District

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Central venous access device; Adaptive platform trial; Chlorhexidine cap; Chlorhexidine connector; Subcutaneous anchor; Central line-associated blood stream infection
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Pathological Conditions, Signs and Symptoms; Prosthesis-Related Infections
• Other Study ID Numbers: IPVA_26_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes