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The IVCare Adaptive Platform Trial

7. maj 2026 opdateret af: The University of Queensland

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2500

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Connectors/Caps Domain - Standard of care
Enhed: 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.
Eksperimentel: Connectors/Caps Domain - InVision-Plus CS® for the cancer stratum
Enhed: 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.
Eksperimentel: Connectors/Caps Domain - ClearGuard™ HD for the kidney stratum
Enhed: 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.
Eksperimentel: Connectors/Caps Domain - Tego™ for the kidney stratum
Enhed: 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.
Aktiv komparator: Securement Domain - Standard of care
Enhed: 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.
Eksperimentel: Securement Domain - SecurAcath®
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Central Line-Associated Bloodstream Infection (CLABSI)
Tidsramme: 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
Up to 180 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive blood cultures
Tidsramme: 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
Up to 180 days
Catheter-related infection
Tidsramme: 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
180 days
Central Venous Catheter (CVC) exit site infection
Tidsramme: Up to 180 days
CVC exit site infection consistent with the Infectious Diseases Society of America (IDSA) guidelines from 2009
Up to 180 days
Pocket site infection
Tidsramme: Up to 180 days
Pocket site infection consistent with the IDSA guidelines from 2009
Up to 180 days
CVAD failure
Tidsramme: 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.
Up to 180 days
CVAD complications not requiring removal
Tidsramme: Up to 180 days
CVAD complications not requiring removal, defined as a composite measure of any complication not requiring CVAD removal.
Up to 180 days
CVAD insertion complications
Tidsramme: Up to 180 days
CVAD insertion complications, defined as a composite measure of any insertion complications.
Up to 180 days
Health-related quality of life
Tidsramme: Up to 180 days
Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Up to 180 days
Patients' experiences of care
Tidsramme: Up to 180 days
Assessed using the Australian Hospital Patient Experience Question Set (AHPEQS)
Up to 180 days
CVAD-related Serious Adverse Events (SAEs)
Tidsramme: Up to 180 days
Any SAE considered related or possible related to the CVAD.
Up to 180 days
Intervention-related SAEs
Tidsramme: Up to 180 days
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)
Tidsramme: Up to 180 days
Any SAE which meets the definition of an USADE.
Up to 180 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Queensland

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. december 2031

Studieafslutning (Anslået)

1. december 2031

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IPVA_26_01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Kateter infektion

Kliniske forsøg med Connectors/Caps Domain - Standard of Care

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