Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)

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)

Blood cultures (BCs) are a blood test to look for an infection. Two problems with the sample collection are contamination by germs outside of the blood and not collecting enough blood in the tube, resulting in unusable samples. Many patients requiring a BC also have a peripheral intravenous catheter ("catheter") but these are not normally used for blood sampling. This means that patients receive many painful needles for both catheter insertion and blood sampling. There is a needle-free blood collection device (PIVO Pro) which can be used with a catheter to collect a blood sample.

The goal of the PIVO Trial is to see if using the PIVO Pro for blood culture sample collection will have a lower amount of contamination than the usual method of blood sample collection. Patients 18 and older at 3 emergency departments will be included. Research nurses will look for patients in emergency who need a blood culture sample taken and they will be asked if they want to be involved in the trial. Half of the participants will use the PIVO Pro to take their blood sample and half will have the usual way of collecting blood.

Participants do not have to do anything specifically for the trial. Information about the blood collection and results of the blood culture will be collected from the medical records and recorded for the trial.

Study Overview

• Status: Recruiting
• Conditions: Infection; Blood Culture Contamination
• Intervention / Treatment: Device: PIVO-Pro needle-free blood collection device

Detailed Description

The PIVO™ Pro Needle-free Blood Collection Device (Becton, Dickinson and Company; Franklin Lakes) has been available for around a decade and involves advancing a flexible internal flow tube through the patient's Peripheral Intravenous Catheter (PIVC) to access a fresh blood sample beyond the PIVC tip. There is supporting evidence that PIVO is comparable to venepuncture for yielding non-Blood Culture (BC) samples without haemolysis and clotting and with equivalent laboratory values; does not negatively impact PIVC dwell time or replacement rates; decreases preanalytical errors and PIVC replacement; improves the rate and degree of haemolysis in comparison to venepuncture and central line collection; and reduces the prevalence of hospital-onset bacteraemia. However, there are limitations to previous research. Theoretically, for newly inserted PIVCs, the PIVO Pro will bypass a PIVC contaminated on insertion through the skin, to collect a clean blood sample from beyond the tip while also avoiding complications associated with PIVC blood draw. While the PIVO Pro is used in some hospitals as part of standard care, there is a need to confirm results relating to BCs in a randomized controlled trial (RCT).

The aim of this trial is to examine whether use of the PIVO Pro at initial PIVC start, compared to standard practice, decreases BC draw contamination rates.

Based on the aim, the primary objective is to compare the efficacy of the PIVO Pro with initial PIVC start for reducing contaminated BC episodes, to standard practice for BC set draw. 1148 adult participants will be randomised into the trial.

The secondary objectives are to:

1. Compare the effect of the PIVO Pro with initial PIVC start on fill volume of BC bottles, to standard practice for BC set draw.
2. Compare the efficacy of the PIVO Pro with initial PIVC start for improving the overall quality of BC set samples (composite of non-contamination and adequate fill volume), to standard practice for BC set draw.
3. Compare the efficacy of (i) the PIVO Pro (ii) venepuncture, and (iii) draw from initial PIVC start for BC set draw to achieve non-contamination and adequate fill volume
4. Compare the efficacy of the PIVO Pro with initial PIVC start for reducing antibiotic use, to standard practice for BC set draw.

At one hospital site, a sub-study will be conducted to compare PIVC failure outcomes following BC draw with the PIVO Pro with initial PIVC start, to BC set draw directly from a PIVC. The aim of the sub-study is to compare the rate of thrombus development and narrowing of vessel diameter (mm) in those participants that develop PIVC-associated complications versus those participants who do not.

• Study Type: Interventional
• Enrollment (Estimated): 1148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Valks; Phone Number: +61 7 3346 6012; Email: PIVO@uq.edu.au
• Study Contact Backup: Name: Claire Rickard; Email: c.rickard@uq.edu.au

Study Locations

• Australia
  • Queensland
    • Caboolture, Queensland, Australia, 4510
      • Recruiting
      • Caboolture Hospital
      • Contact: Karen Furlong; Phone Number: +61 7 5433 8888; Email: Karen.Furlong2@health.qld.gov.au
    • Redcliffe, Queensland, Australia, 4020
      • Recruiting
      • Redcliffe Hospital
      • Contact: Jason Chan; Phone Number: +61 7 3883 7777; Email: Jason.Chan@health.qld.gov.au
    • Robina, Queensland, Australia, 4226
      • Recruiting
      • Robina Hospital
      • Contact: Gerben Keijzers; Phone Number: +61 1300 744 284; Email: gerben.keijzers@health.qld.gov.au
    • Southport, Queensland, Australia, 4215
      • Recruiting
      • The Gold Coast University Hospital
      • Contact: Gerben Keijzers; Phone Number: +61 1300 744 284; Email: gerben.keijzers@health.qld.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Blood culture requested due to suspected bloodstream infection
• Patients receiving a 22 gauge short peripheral intravenous catheter (or larger)

Exclusion Criteria:

• Patients who have already commenced intravenous antimicrobial medications in the emergency department

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PIVO-Pro Intervention arm; In the PIVO Pro arm blood culture (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 peripheral intravenous catheter (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	Device: PIVO-Pro needle-free blood collection device; The PIVO™ Pro Needle-free Blood Collection Device advances a flexible flow tube through the intravenous catheter to access optimal blood draw conditions, overcoming traditional hurdles to collect high-quality, reliable blood samples.
No Intervention: Control arm; In the control arm, all blood culture (BC) sets will be collected using standard practice (typically 1 each for venepuncture/draw from a newly inserted peripheral intravenous catheter).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood culture draw success without contamination.	Blood culture draw contamination measured as laboratory identification of a common skin commensal in a single blood culture (BC) set in an episode. Should the same common skin commensal be identified by culture in ≥ 2 blood specimens collected on separate occasions (same or consecutive days; e.g., on the same day as the trial BC set/s draw but several hours later) AND the blood cultures are assigned separate specimen numbers, processed individually, and are reported separately in the final laboratory report, the result will be reclassified as being positive (i.e., not contaminated).	Measured at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood culture draw underfill	Inoculation of blood to optimal fill line on bottles or reported by pathology.	Measured at baseline
Blood culture set quality	Measured as a composite of blood culture non-contamination and adequate fill volume.	Measured at baseline
Antibiotic use	Measured as commencement of any antibiotic in response to blood culture results.	Within 1 week of baseline.

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: Becton, Dickinson and Company
• Investigators: Principal Investigator: Claire Rickard, The University of Queensland

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PIVO Pro; Reducing blood culture contamination; Needle-less blood draw
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: IPVA_24.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No