Skip to main content
OpenTrials
Completed

NCT Number: NCT03711331

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pneumonia, Ventilator-Associated Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

FilmArray® Pneumonia panel plus

Other

Early adjustment of antimicrobial therapy according to the results of the Unyvero® testing for patients suspected with VAP or HAP requiring MV.

Standard care

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Number of Patient Deaths

    Time frame: at 28 days after antibiotics start

    number of patient deaths after antibiotics start

  5. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Curetis GmbH

Registry information

Official study 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

Acronym: VAPERO

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2018
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.