Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Queensland
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Blood culture requested due to suspected bloodstream infection
Patients receiving a 22 gauge short peripheral intravenous catheter (or larger)
Disqualifiers
Patients who have already commenced intravenous antimicrobial medications in the emergency department
Trial design
Design model
Parallel
Treatments tested in this trial
PIVO-Pro needle-free blood collection device
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.
Treatment groups
1,148 Participants
are divided into 2 treatment groupsGroup A: PIVO-Pro Intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
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).
Time frame
Measured at baselineSecondary outcomes
1
Blood culture draw underfill
Inoculation of blood to optimal fill line on bottles or reported by pathology.
Time frame
Measured at baseline2
Blood culture set quality
Measured as a composite of blood culture non-contamination and adequate fill volume.
Time frame
Measured at baseline3
Antibiotic use
Measured as commencement of any antibiotic in response to blood culture results.
Time frame
Within 1 week of baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Queensland
Lead sponsor
Becton, Dickinson and Company
Collaborator
Source ClinicalTrials.gov