Pneumonia, Bacterial, Pneumonia, Ventilator-Associated
Conditions
Keywords
Ventilator-associated pneumonia, Hospital-acquired pneumonia, Antimicrobial therapy, Ventilator-associated pneumonia Hospital-acquired pneumonia Antimicrobial therapy Polymerase chain reaction Antibiotics stewardship, Polymerase chain reaction, Antibiotics stewardship
Brief summary
VAPERO is a randomized, unblinded, controlled study to measure the impact of a strategy based on the Unyvero® multiplex PCR test on the adjustment of antimicrobial therapy in patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation. The gold-standard microbiological diagnostic method for pneumonia in the ICU is still culture-based identification and antimicrobial susceptibility testing (AST) despite being more than a hundred years old, with results turnaround time spanning over several days, exposing patients to potentially inappropriate broad-spectrum antimicrobial therapy. The investigators aim to measure the impact of the Unyvero® testing strategy to improve the percentage of patients with VAP or HAP receiving early targeted antimicrobial therapy compared to standard care.
Interventions
OTHERFilmArray® Pneumonia panel plus
Early adjustment of antimicrobial therapy according to the results of the Unyvero® testing for patients suspected with VAP or HAP requiring MV.
OTHERStandard care
Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results
Sponsors
University Hospital, Lille
Curetis GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients hospitalized in the ICU * suspected with VAP or HAP requiring MV
Exclusion criteria
* Severe immunodeficiency * Moribund patients (SAPS II \> 90)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with targeted antibiotics regimen 24 hours after starting antimicrobial therapy in the experimental group compared to control group | 24 hours after the initiation of empiric antimicrobial therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients receiving appropriate antimicrobial therapy 24 hours after antibiotics initiation | 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start | — |
| Amount of days alive and free from mechanical ventilation at day 28 after antibiotics initiation. | 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start | — |
| Length of stay in Intensive Care Unit | 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start | — |
| Number of Patient Deaths | at 28 days after antibiotics start | number of patient deaths after antibiotics start |
| number of patient deaths in ICU | 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORSaad Nseir, MD,PhD
University Hospital, Lille
Outcome results
None listed