Using the PIVO needle-free device to reduce blood culture contamination
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)
This trial will test whether using the PIVO Pro needle-free device to collect blood from adults in the emergency department who need blood cultures reduces contamination compared with the usual collection method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Queensland Academic / other |
| Locations | 4 sites (Caboolture, Queensland and 3 other locations) |
| Trial ID | NCT06806709 on ClinicalTrials.gov |
What this trial studies
This randomized trial at three Australian emergency departments will compare blood culture contamination rates when samples are collected using the PIVO Pro needle-free device at initial peripheral IV catheter (PIVC) insertion versus standard blood collection methods. Adults aged 18 and older who require a blood culture and receive a 22-gauge (or larger) PIVC will be enrolled unless they have already started IV antibiotics. Research nurses will identify eligible patients in the ED, obtain consent, and record contamination outcomes for the blood culture samples. The primary outcome is the rate of contaminated blood cultures; secondary outcomes include sample adequacy and need for repeat draws.
Who should consider this trial
Good fit: Adults (18+) in the participating emergency departments who need a blood culture and are having a 22-gauge or larger peripheral IV catheter placed are ideal candidates.
Not a fit: Patients who have already started IV antibiotics in the emergency department, who do not have a suitable peripheral IV catheter, or pediatric patients are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, using PIVO Pro could lower contaminated blood cultures, reduce repeat painful needle sticks, and decrease unnecessary antibiotics and follow-up testing.
How similar studies have performed: Previous studies have shown PIVO performs similarly to venepuncture for routine blood tests and reduces some preanalytical errors, but randomized data specifically addressing blood culture contamination are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Caboolture, Queensland and 3 other locations
- Caboolture Hospital — Caboolture, Queensland, Australia (Recruiting)
- Redcliffe Hospital — Redcliffe, Queensland, Australia (Recruiting)
- Robina Hospital — Robina, Queensland, Australia (Recruiting)
- The Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
Study contacts
- Principal investigator: Claire Rickard — The University of Queensland
- Study coordinator: Andrea Valks
- Email: PIVO@uq.edu.au
- Phone: +61 7 3346 6012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.