CRBSI - Catheter Related Bloodstream InfectionNCT06604026
Investigational Study With the BD PosiFlush™ SafeScrub on NADs
A study testing BD PosiFlush™ SafeScrub and BD PosiFlush™ in people with CRBSI - Catheter Related Bloodstream Infection, run by Becton, Dickinson and Company at 2 sites in Austria.
Trial summary
This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRBSI - Catheter Related Bloodstream Infection
- What is being tested?
- BD PosiFlush™ SafeScrub and BD PosiFlush™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesAustria
- Study dates
- 22 Oct 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient (≥18 years of age) in a high acuity hospital medical or surgical unit regardless of gender, with an eligible in-situ vascular access device and with a needleless access device (NAD). This includes patients who have a current VAD, whether it is newly placed or long-term access as part of their routine medical care. Eligible in-situ vascular access devices are peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs) and implanted venous access ports. Eligible NADs are stopcocks, Y-sites, and needle-free connectors.
- Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access.
- Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.
Who cannot join
- Any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team.
- Patients under the age of 18.
- Patients suffering hypernatremia and fluid retention, when the administration of sodium or chloride could be clinically detrimental as determined by the study investigator.
- Patients with a known allergy to any of the followings as determined by the study investigator:
- Any of the components or materials of BD PosiFlush™ SafeScrub device or BD PosiFlush™ SP Syringe, or
- 0.9% sodium chloride solution
- Pregnant or breastfeeding women
- Urine pregnancy test will be required for all women of childbearing age who want to participate in the study
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, 4020
Medical University Vienna
Vienna
About this study
Official title: An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices
This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.
Read the detailed description
This study is being conducted to generate clinical data to support the performance and safety of BD PosiFlush™ SafeScrub. The study data will be used for regulatory submission in EU.
- Being tested
- BD PosiFlush™ SafeScrub, BD PosiFlush™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD PosiFlush™ SafeScrubDevice
Clinicians will be advised to use BD PosiFlush™ SafeScrub as per the Instructions for Use for the treatment arm of the study.
An independent nurse observer will observe and document any adverse events (e.g.
local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process.
BD PosiFlush™Device
Clinicians will be advised to follow and document the respective unit protocol, while using the standard pre-filled syringe (BD PosiFlush™ SP Syringe) and alcohol pad for scrubbing and flushing of NADs in the control arm of the study as the routine practice.
An independent nurse observer will observe and document any adverse events (e.g.
local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | use of the BD PosiFlush™ SafeScrub device Receives: Device: BD PosiFlush™ SafeScrub |
| Control Arm | Active comparator | pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad Receives: Device: BD PosiFlush™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related adverse events
To assess the incidence of BD PosiFlush™ SafeScrub device-related adverse events up to 15 min after each access
Measured: 15 minutes
Secondary outcomes (2)
Compliance rate of device scrubbing
To assess if the compliance rate of needleless access device scrubbing before flushing with use of BD PosiFlush™ SafeScrub is higher compared to standard practice (i.e., use of pre-filled syringe (BD PosiFlush™ SP Syringe) and an alcohol pad) up to 15 min after each access
Measured: 15 minutes
Device success rate
To assess the performance of the BD PosiFlush™ SafeScrub. Percent success rate (≥85%) for BD PosiFlush™ SafeScrub to encapsulate the needleless access device, and to be removed from the needleless access device up to 15 min after each access
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Oct 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRBSI - Catheter Related Bloodstream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At each participating site, one medical or surgical unit will conduct the treatment arm and one unit will conduct the control arm randomizing which unit will perform the treatment or control arm at the study site.
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Van Laethem, Study chair, Becton, Dickinson and Company BD Medication Delivery Systems/Catheter Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604026
- Sponsor's protocol ID
- MDS-23PFINTEU001
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices
- ClinicalTrials.gov ID
- NCT06604026
- Acronym / sponsor ID
- MDS-23PFINTEU001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.
Detailed description
This study is being conducted to generate clinical data to support the performance and safety of BD PosiFlush™ SafeScrub. The study data will be used for regulatory submission in EU.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At each participating site, one medical or surgical unit will conduct the treatment arm and one unit will conduct the control arm randomizing which unit will perform the treatment or control arm at the study site.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: BD PosiFlush™ SafeScrubuse of the BD PosiFlush™ SafeScrub device |
| Control Arm | Active comparator | Device: BD PosiFlush™pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient (≥18 years of age) in a high acuity hospital medical or surgical unit regardless of gender, with an eligible in-situ vascular access device and with a needleless access device (NAD). This includes patients who have a current VAD, whether it is newly placed or long-term access as part of their routine medical care. Eligible in-situ vascular access devices are peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs) and implanted venous access ports. Eligible NADs are stopcocks, Y-sites, and needle-free connectors.
- Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access.
- Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.
Key exclusion criteria (8 listed)
- Any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team.
- Patients under the age of 18.
- Patients suffering hypernatremia and fluid retention, when the administration of sodium or chloride could be clinically detrimental as determined by the study investigator.
- Patients with a known allergy to any of the followings as determined by the study investigator:
- Any of the components or materials of BD PosiFlush™ SafeScrub device or BD PosiFlush™ SP Syringe, or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD PosiFlush™ SafeScrubClinicians will be advised to use BD PosiFlush™ SafeScrub as per the Instructions for Use for the treatment arm of the study. An independent nurse observer will observe and document any adverse events (e.g. local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process. | Device | Treatment arm |
| BD PosiFlush™Clinicians will be advised to follow and document the respective unit protocol, while using the standard pre-filled syringe (BD PosiFlush™ SP Syringe) and alcohol pad for scrubbing and flushing of NADs in the control arm of the study as the routine practice. An independent nurse observer will observe and document any adverse events (e.g. local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process. | Device | Control Arm |
Primary outcome
Device related adverse events
Time frame: 15 minutes
To assess the incidence of BD PosiFlush™ SafeScrub device-related adverse events up to 15 min after each access
2 secondary outcomes
Compliance rate of device scrubbing
Time frame: 15 minutes
Device success rate
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Van Laethem study chair
Becton, Dickinson and Company BD Medication Delivery Systems/Catheter Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD PosiFlush™ SafeScrub and BD PosiFlush™ in people with CRBSI - Catheter Related Bloodstream Infection, run by Becton, Dickinson and Company at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device related adverse events (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.