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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
161
Early adjustment of antimicrobial therapy according to the results of the Unyvero® testing for patients suspected with VAP or HAP requiring MV.
Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results
CHU Lille
Lille, France
Percentage of patients with targeted antibiotics regimen 24 hours after starting antimicrobial therapy in the experimental group compared to control group
Time frame: 24 hours after the initiation of empiric antimicrobial therapy
Percentage of patients receiving appropriate antimicrobial therapy 24 hours after antibiotics initiation
Time frame: 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.
Time frame: 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
Time frame: 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
number of patient deaths after antibiotics start
Time frame: at 28 days after antibiotics start
number of patient deaths in ICU
Time frame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start
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