Impact of a Strategy Based on the Unyvero® Testing System on Appropriate and Targeted Antimicrobial Treatment in Patients With Suspected VAP or HAP Requiring Mechanical Ventilation: a Randomized Controlled Unblinded Trial

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients hospitalized in the ICU

• suspected with VAP or HAP requiring MV

Locations
Other Locations
France
CHU Lille
Lille
Time Frame
Start Date: 2020-06-16
Completion Date: 2023-09-22
Participants
Target number of participants: 161
Treatments
Experimental: FilmArray® Pneumonia panel plus strategy
patients benefiting from the new strategy based on the system Unyvero ®
Sham_comparator: Standard care
patients benefiting from usual standard care
Related Therapeutic Areas
Sponsors
Collaborators: Curetis GmbH
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov