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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pneumonia, Ventilator-Associated, Pneumonia, Bacterial

Intervention / Treatment
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* Other: FilmArray® Pneumonia panel plus
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients hospitalized in the ICU suspected with VAP or HAP requiring MV Exclusion Criteria: Severe immunodeficiency Moribund patients (SAPS II > 90)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FilmArray® Pneumonia panel plus strategy<br>patients benefiting from the new strategy based on the system Unyvero ® | Other: FilmArray® Pneumonia panel plus<br>* Early adjustment of antimicrobial therapy according to the results of the Unyvero® testing for patients suspected with VAP or HAP requiring MV.<br>|
| Sham Comparator: Standard care<br>patients benefiting from usual standard care | Other: Standard care<br>* Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilator-associated pneumonia, Hospital-acquired pneumonia, Antimicrobial therapy, Ventilator-associated pneumonia Hospital-acquired pneumonia Antimicrobial therapy Polymerase chain reaction Antibiotics stewardship, Polymerase chain reaction, Antibiotics stewardship