NCT03711331

Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Patients With Hospital-acquired Pneumonia

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia, Ventilator-Associated
• Pneumonia, Bacterial

Interventions

Type	Name	Description
OTHER	FilmArray® 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.
OTHER	Standard care	Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results

Timeline

• Start date: 2020-06-16
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2018-10-18
• Last updated: 2026-04-07

Locations

1 site across 1 country: France