An interventional study of Connectors/Caps Domain - Standard of Care and Curos™ in Device Related Infection, Vascular Access Complication and Device Related Sepsis, sponsored by The University of Queensland. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by The University of Queensland · Not applicable, Interventional, and Prevention
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.
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.
35 studies on the registry are indexed under Prosthesis-Related Infections; 10 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 193 across 20 interventional studies indexed under Prosthesis-Related Infections.
Browse Prosthesis-Related Infections studies →The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Core inclusion Criteria:
Securement Domain exclusion criteria:
Connectors/Caps Domain exclusion criteria:
Cancer stratum inclusion criteria:
Kidney stratum exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Connectors/Caps Domain - Standard of Care
Device: Curos™
Device: ClearGuard™ HD
Device: Tego™
Device: Securement Domain - Standard of Care
Device: SecurAcath®
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™ 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
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™ 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.
Basic securement using sterile tape/adhesion fixation device and a simple transparent dressing, without antimicrobial, antiseptic, or engineered stabilization features.
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.
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
Time frame: Up to 180 days
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
Time frame: 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
Time frame: 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
Time frame: Up to 180 days
Pocket site infection
Pocket site infection consistent with the IDSA guidelines from 2009
Time frame: 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.
Time frame: 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.
Time frame: Up to 180 days
CVAD insertion complications
CVAD insertion complications, defined as a composite measure of any insertion complications.
Time frame: Up to 180 days
Health-related quality of life
Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Time frame: Up to 180 days
Patients' experiences of care
Assessed using the Australian Hospital Patient Experience Question Set (AHPEQS)
Time frame: Up to 180 days
CVAD-related Serious Adverse Events (SAEs)
Any SAE considered related or possible related to the CVAD.
Time frame: 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.
Time frame: Up to 180 days
Unanticipated Serious Adverse Device Effect (USADEs)
Any SAE which meets the definition of an USADE.
Time frame: Up to 180 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2031, 60 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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The University of Queensland