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

Primary Purpose

Pneumonia, Ventilator-Associated, Pneumonia, Bacterial

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FilmArray® Pneumonia panel plus
Standard care
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Ventilator-Associated focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • CHU LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

FilmArray® Pneumonia panel plus strategy

Standard care

Arm Description

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

patients benefiting from usual standard care

Outcomes

Primary Outcome Measures

Percentage of patients with targeted antibiotics regimen 24 hours after starting antimicrobial therapy in the experimental group compared to control group

Secondary Outcome Measures

Percentage of patients receiving appropriate antimicrobial therapy 24 hours after antibiotics initiation
Amount of days alive and free from mechanical ventilation at day 28 after antibiotics initiation.
Length of stay in Intensive Care Unit
Number of Patient Deaths
number of patient deaths after antibiotics start
number of patient deaths in ICU

Full Information

First Posted
October 16, 2018
Last Updated
December 15, 2022
Sponsor
University Hospital, Lille
Collaborators
Curetis GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03711331
Brief Title
Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Patients With Hospital-acquired Pneumonia
Acronym
VAPERO
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Curetis GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-Associated, Pneumonia, Bacterial
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FilmArray® Pneumonia panel plus strategy
Arm Type
Experimental
Arm Description
patients benefiting from the new strategy based on the system Unyvero ®
Arm Title
Standard care
Arm Type
Sham Comparator
Arm Description
patients benefiting from usual standard care
Intervention Type
Other
Intervention Name(s)
FilmArray® Pneumonia panel plus
Intervention Description
Early adjustment of antimicrobial therapy according to the results of the Unyvero® testing for patients suspected with VAP or HAP requiring MV.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results
Primary Outcome Measure Information:
Title
Percentage of patients with targeted antibiotics regimen 24 hours after starting antimicrobial therapy in the experimental group compared to control group
Time Frame
24 hours after the initiation of empiric antimicrobial therapy
Secondary Outcome Measure Information:
Title
Percentage of patients receiving appropriate antimicrobial therapy 24 hours after antibiotics initiation
Time Frame
24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start
Title
Amount of days alive and free from mechanical ventilation at day 28 after antibiotics initiation.
Time Frame
24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start
Title
Length of stay in Intensive Care Unit
Time Frame
24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start
Title
Number of Patient Deaths
Description
number of patient deaths after antibiotics start
Time Frame
at 28 days after antibiotics start
Title
number of patient deaths in ICU
Time Frame
24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients hospitalized in the ICU suspected with VAP or HAP requiring MV Exclusion Criteria: Severe immunodeficiency Moribund patients (SAPS II > 90)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saad Nseir, MD,PhD
Phone
320 44 44 95
Ext
+33
Email
saad.nseir@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Nseir, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Lille
City
Lille
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
33395094
Citation
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.
Results Reference
derived

Learn more about this trial

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

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