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 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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
実験的：Connectors/Caps Domain - ClearGuard™ HD for the kidney stratum
|
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.
|
|
実験的：Connectors/Caps Domain - Tego™ for the kidney stratum
|
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.
|
|
アクティブコンパレータ：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.
|
|
実験的：Securement Domain - 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.
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|
実験的：Connectors/Caps Domain - Curos™ for the cancer stratum
|
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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Central Line-Associated Bloodstream Infection (CLABSI)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Positive blood cultures
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 180 days
|
Pocket site infection consistent with the IDSA guidelines from 2009
|
Up to 180 days
|
|
CVAD failure
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 180 days
|
Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
|
Up to 180 days
|
|
Patients' experiences of care
時間枠：Up to 180 days
|
Assessed using the Australian Hospital Patient Experience Question Set (AHPEQS)
|
Up to 180 days
|
|
CVAD-related Serious Adverse Events (SAEs)
時間枠：Up to 180 days
|
Any SAE considered related or possible related to the CVAD.
|
Up to 180 days
|
|
Intervention-related SAEs
時間枠：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)
時間枠：Up to 180 days
|
Any SAE which meets the definition of an USADE.
|
Up to 180 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IPVA_26_01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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