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

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

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 Overview

• Status: Completed
• Conditions: Pneumonia, Bacterial; Pneumonia, Ventilator-Associated
• Intervention / Treatment: Other: FilmArray® Pneumonia panel plus; Other: Standard care

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients hospitalized in the ICU
• suspected with VAP or HAP requiring MV

Exclusion Criteria:

• Severe immunodeficiency
• Moribund patients (SAPS II > 90)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	number of patient deaths after antibiotics start	at 28 days 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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Curetis GmbH
• Investigators: Principal Investigator: Saad NSEIR, MD,PhD, University Hospital, Lille

Publications and helpful links

General Publications

• Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hospital-acquired pneumonia; Ventilator-associated pneumonia; Polymerase chain reaction; Antimicrobial therapy; Ventilator-associated pneumonia Hospital-acquired pneumonia Antimicrobial therapy Polymerase chain reaction Antibiotics stewardship; Antibiotics stewardship
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Bacterial Infections; Bacterial Infections and Mycoses; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2017_37; 2018-A00149-46 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No