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

NCT06806709 | Recruiting DMC

• 1 other identifier: IPVA_24.01
• Study Type: interventional
• Target: 1,148
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Infection; Blood Culture Contamination

Keywords

PIVO Pro; Reducing blood culture contamination; Needle-less blood draw

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Blood culture draw underfill

  Measured at baseline

• Blood culture set quality

  Measured at baseline

• Antibiotic use

  Within 1 week of baseline.

Study Arms (2)

PIVO-Pro Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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).

Interventions

PIVO-Pro needle-free blood collection device 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.

PIVO-Pro Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Queensland: lead
• Becton, Dickinson and Company: collaborator

Study Sites (4)

Caboolture Hospital

Caboolture, Queensland, 4510, Australia

RECRUITING

Redcliffe Hospital

Redcliffe, Queensland, 4020, Australia

RECRUITING

Robina Hospital

Robina, Queensland, 4226, Australia

RECRUITING

The Gold Coast University Hospital

Southport, Queensland, 4215, Australia

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

• Claire Rickard

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Valks

CONTACT

+61 7 3346 6012; PIVO@uq.edu.au

Claire Rickard

CONTACT

c.rickard@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pathology providers will be blinded to the sample collection type. The trial steering committee will remain blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 4, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)