Clinical trial NCT03711331: Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Patients With Hospital-acquired Pneumonia
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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Curetis GmbH
First posted: 2018-10-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Percentage of patients with targeted antibiotics regimen 24 hours after starting antimicrobial therapy in the experimental group compared to control group
timeFrame: 24 hours after the initiation of empiric antimicrobial therapy
Secondary outcomes:
measure: Percentage of patients receiving appropriate antimicrobial therapy 24 hours after antibiotics initiation
timeFrame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start
measure: Amount of days alive and free from mechanical ventilation at day 28 after antibiotics initiation.
timeFrame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start
measure: Length of stay in Intensive Care Unit
timeFrame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start
measure: Number of Patient Deaths
timeFrame: at 28 days after antibiotics start
measure: number of patient deaths in ICU
timeFrame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Saad Nseir, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.