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

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03711331

Collaborator

Curetis GmbH (Industry)

160

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Ventilator-Associated Pneumonia, Bacterial	Other: FilmArray® Pneumonia panel plus Other: Standard care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 16, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FilmArray® Pneumonia panel plus strategy patients benefiting from the new strategy based on the system Unyvero ®	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.
Sham Comparator: Standard care patients benefiting from usual standard care	Other: Standard care Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results

Arm

Intervention/Treatment

Experimental: FilmArray® Pneumonia panel plus strategy

patients benefiting from the new strategy based on the system Unyvero ®

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.

Sham Comparator: Standard care

patients benefiting from usual standard care

Other: Standard care

Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]