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

NCT ID: NCT03711331

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2023-09-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FilmArray® Pneumonia panel plus strategy

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

Group Type: EXPERIMENTAL

FilmArray® Pneumonia panel plus

Intervention Type: 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

patients benefiting from usual standard care

Group Type: SHAM_COMPARATOR

Standard care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Standard care

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Curetis GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saad Nseir, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CHU Lille

Lille, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 33395094 (View on PubMed)

Other Identifiers

2018-A00149-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017_37

Identifier Type: -

Identifier Source: org_study_id