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

NCT03711331 | Completed

• 2 other identifiers: 2017_372018-A00149-46
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 in ICU

  24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start

Study Arms (2)

FilmArray® Pneumonia panel plus strategy

EXPERIMENTAL

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

Other: FilmArray® Pneumonia panel plus

Standard care

SHAM COMPARATOR

patients benefiting from usual standard care

Other: Standard care

Interventions

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.

FilmArray® Pneumonia panel plus strategy

Standard care OTHER

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

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Curetis GmbH: collaborator

Study Sites (1)

CHU Lille

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 33395094 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Healthcare-Associated Pneumonia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Saad Nseir, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: June 16, 2020
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)