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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor 2 versions Re-verified since Aug 30, 2026, no change to tracked fieldsv6-v7
  2. Minor Study description shortened, about 32 wordsv5
  3. Minor Study sites: 3 to 4
    • Primary completion date: Jul 30, 2026 to Oct 30, 2026
    • Study completion date: Aug 2026 to Dec 31, 2026
    v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2025 to Aug 18, 2025
    • Site details revised at 3 of 3 sites
    v3
  5. Minor Study title shortened, about 9 words
    • Eligibility criteria expanded, about 3 words
    • Study description expanded, about 2 words
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06806709
Lead Sponsor The University of Queensland
Collaborators: Becton, Dickinson and Company
Conditions
(from sponsor)
Blood Culture Contamination, Infection
Related terms Infections
Enrollment 1,148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov