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The IVCare Adaptive Platform Trial

7 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

2500

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Connectors/Caps Domain - Standard of care
Dispositivo: 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.
Sperimentale: Connectors/Caps Domain - InVision-Plus CS® for the cancer stratum
Dispositivo: 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.
Sperimentale: Connectors/Caps Domain - ClearGuard™ HD for the kidney stratum
Dispositivo: 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.
Sperimentale: Connectors/Caps Domain - Tego™ for the kidney stratum
Dispositivo: 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.
Comparatore attivo: Securement Domain - Standard of care
Dispositivo: 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.
Sperimentale: Securement Domain - SecurAcath®
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Central Line-Associated Bloodstream Infection (CLABSI)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Positive blood cultures
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 180 days
Pocket site infection consistent with the IDSA guidelines from 2009
Up to 180 days
CVAD failure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 180 days
Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Up to 180 days
Patients' experiences of care
Lasso di tempo: Up to 180 days
Assessed using the Australian Hospital Patient Experience Question Set (AHPEQS)
Up to 180 days
CVAD-related Serious Adverse Events (SAEs)
Lasso di tempo: Up to 180 days
Any SAE considered related or possible related to the CVAD.
Up to 180 days
Intervention-related SAEs
Lasso di tempo: 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)
Lasso di tempo: Up to 180 days
Any SAE which meets the definition of an USADE.
Up to 180 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Queensland

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 dicembre 2031

Completamento dello studio (Stimato)

1 dicembre 2031

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IPVA_26_01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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