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

University Hospital, Lille

Status: Completed

Conditions: Pneumonia, Ventilator-Associated; Pneumonia, Bacterial

Treatments: Other: Standard care; Other: FilmArray® Pneumonia panel plus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03711331

2018-A00149-46 (Other Identifier)

2017_37

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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161 participants in 2 patient groups

FilmArray® Pneumonia panel plus strategy

Experimental group

Description:

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

Treatment:

Other: FilmArray® Pneumonia panel plus

Standard care

Sham Comparator group

Description:

patients benefiting from usual standard care

Treatment:

Other: Standard care