Blood Culture ContaminationNCT06806709
Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)
A study testing PIVO-Pro needle-free blood collection device in people with Blood Culture Contamination and Infection, run by The University of Queensland at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Culture Contamination, Infection
- What is being tested?
- PIVO-Pro needle-free blood collection device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,148 participants
- Where
- 4 sitesAustralia
- Study dates
- 18 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Blood culture requested due to suspected bloodstream infection
- Patients receiving a 22 gauge short peripheral intravenous catheter (or larger)
Who cannot join
- Patients who have already commenced intravenous antimicrobial medications in the emergency department
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Caboolture Hospital
Caboolture, Queensland, 4510
Redcliffe Hospital
Redcliffe, Queensland, 4020
Robina Hospital
Robina, Queensland, 4226
The Gold Coast University Hospital
Southport, Queensland, 4215
About this study
Official 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)
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.
Read the 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:
- Compare the effect of the PIVO Pro with initial PIVC start on fill volume of BC bottles, to standard practice for BC set draw.
- 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.
- Compare the efficacy of the PIVO Pro with initial PIVC start for reducing antibiotic use, to standard practice for BC set draw.
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.
- Conditions
- Blood Culture Contamination, Infection
- Being tested
- PIVO-Pro needle-free blood collection device
- Keywords
- PIVO Pro, Reducing blood culture contamination, Needle-less blood draw
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIVO-Pro needle-free blood collection deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline
Secondary outcomes (3)
Blood culture draw underfill
Inoculation of blood to optimal fill line on bottles or reported by pathology.
Measured: Measured at baseline
Blood culture set quality
Measured as a composite of blood culture non-contamination and adequate fill volume.
Measured: Measured at baseline
Antibiotic use
Measured as commencement of any antibiotic in response to blood culture results.
Measured: Within 1 week of baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start18 Aug 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Culture ContaminationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Sponsor
- Investigators
- Claire Rickard, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806709
- Sponsor's protocol ID
- IPVA_24.01
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data (including the data dictionary), statistical coding and other materials (data collection forms, data management procedures, DSMB charter) are available from the authors on reasonable request and within the scope of trial ethical approval once the primary results have been published. Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis. Ethics approval will be required.
Publications
Lovegrove J, Valks A, Ball D, Harris PNA, Martin A, Langan G, Havers S, Vico Da Silva JJ, Keijzers G, Read B, Chan J, Furlong K, Schults J, Rickard C. Efficacy of a needle-free blood collection device (PIVO Pro) for avoiding contaminated blood culture sets in Australian emergency departments: protocol for an adaptive group sequential randomised controlled trial. BMJ Open. 2026 Sep 28;16(9):e125374. doi: 10.1136/bmjopen-2026-125374.
PubMed 42805640
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06806709
- Acronym / sponsor ID
- IPVA_24.01
- Conditions
- Blood Culture Contamination, Infection
- Keywords
- PIVO Pro, Reducing blood culture contamination, Needle-less blood draw
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,148 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Feb 2025 (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.
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.
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:
- Compare the effect of the PIVO Pro with initial PIVC start on fill volume of BC bottles, to standard practice for BC set draw.
- 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.
- Compare the efficacy of the PIVO Pro with initial PIVC start for reducing antibiotic use, to standard practice for BC set draw.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIVO-Pro Intervention arm | Experimental | Device: PIVO-Pro needle-free blood collection deviceIn 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 |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Blood culture requested due to suspected bloodstream infection
- Patients receiving a 22 gauge short peripheral intravenous catheter (or larger)
Key exclusion criteria (1 listed)
- Patients who have already commenced intravenous antimicrobial medications in the emergency department
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 |
|---|---|---|
| PIVO-Pro needle-free blood collection deviceThe 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. | Device | PIVO-Pro Intervention arm |
Primary outcome
Blood culture draw success without contamination.
Time frame: Measured at baseline
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).
3 secondary outcomes
Blood culture draw underfill
Time frame: Measured at baseline
Blood culture set quality
Time frame: Measured at baseline
Antibiotic use
Time frame: Within 1 week of baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 42805640Lovegrove J, Valks A, Ball D, Harris PNA, Martin A, Langan G, Havers S, Vico Da Silva JJ, Keijzers G, Read B, Chan J, Furlong K, Schults J, Rickard C. Efficacy of a needle-free blood collection device (PIVO Pro) for avoiding contaminated blood culture sets in Australian emergency departments: protocol for an adaptive group sequential randomised controlled trial. BMJ Open. 2026 Sep 28;16(9):e125374. doi: 10.1136/bmjopen-2026-125374.
- Individual participant dataSharing planned: Yes. Data (including the data dictionary), statistical coding and other materials (data collection forms, data management procedures, DSMB charter) are available from the authors on reasonable request and within the scope of trial ethical approval once the primary results have been published. Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis. Ethics approval will be required.
Related trials for Blood Culture Contamination
RecruitingObservational study
Impact of Blood Cultures Drawn From Arterial Lines on the Incidence of Contamination, Detection of Bacteremia, and Blood Culture Volume
Bacteremia
Active, not recruiting
Blood Culture Collection Strategies for Suspected Bloodstream Infection
Bacteremia and Sepsis, Bloodstream Infection
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.
Claire Rickard principal investigator
The University of Queensland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIVO-Pro needle-free blood collection device in people with Blood Culture Contamination and Infection, run by The University of Queensland at 4 sites in Australia.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Blood culture draw success without contamination. (time frame: Measured at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806709, which also lists 1 linked publication.
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 27 Oct 2026.