Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06806709




Registration number
NCT06806709
Ethics application status
Date submitted
28/01/2025
Date registered
4/02/2025

Titles & IDs
Public title
Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (PIVO Pro): An Adaptive Group Sequential Randomized Controlled Trial (The PIVO Trial)
Scientific title
Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (PIVO Pro): An Adaptive Group Sequential Randomized Controlled Trial (The PIVO Trial)
Secondary ID [1] 0 0
IPVA_24.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Culture Contamination 0 0
Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PIVO-Pro needle-free blood collection device

Experimental: PIVO-Pro Intervention arm - In the PIVO Pro arm BC sets will also be collected following standard practice, with the addition of PIVO Pro use to draw one BC set from a newly inserted short PIVC. All steps of care will follow standard practice, with use of the PIVO Pro an additional step. Any further BC sets taken at the same time will be collected from a different body location using venepuncture performed as per standard practice. The PIVO Pro BC collection will follow a set procedure, with all steps performed using aseptic technique

No intervention: Control arm - In the control arm, all BC sets will be collected using standard practice (typically 1 each for venepuncture/draw from a newly inserted PIVC).


Treatment: Devices: PIVO-Pro needle-free blood collection device
The PIVO™ Pro Needle-free Blood Collection Device advances a flexible flow tube through the IV catheter to access optimal blood draw conditions, overcoming traditional hurdles to collect high-quality, reliable blood samples
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Blood culture draw success without contamination.
Timepoint [1] 0 0
Measured at baseline
Secondary outcome [1] 0 0
Blood culture draw underfill
Timepoint [1] 0 0
Measured at baseline
Secondary outcome [2] 0 0
Blood culture set quality
Timepoint [2] 0 0
Measured at baseline
Secondary outcome [3] 0 0
Antibiotic use
Timepoint [3] 0 0
Within 1 week of baseline.

Eligibility
Key inclusion criteria
* Blood culture requested due to suspected bloodstream infection
* Patients receiving a 22 gauge short PIVC (or larger)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who have already commenced intravenous antimicrobial medications in the ED

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
1148
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Caboolture Hospital - Caboolture
Recruitment hospital [2] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [3] 0 0
The Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
4510 - Caboolture
Recruitment postcode(s) [2] 0 0
4020 - Redcliffe
Recruitment postcode(s) [3] 0 0
4215 - Southport

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Becton, Dickinson and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claire Rickard
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrea Valks
Address 0 0
Country 0 0
Phone 0 0
+61 7 3346 6012
Fax 0 0
Email 0 0
PIVO@uq.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06806709