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

Pneumonia, Bacterial Clinical Trial

— VAPERO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03711331
• Other study ID #: 2017_37
• Secondary ID: 2018-A00149-46
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: June 2024

Study information

• Verified date: December 2022
• Source: University Hospital, Lille
• Contact: Saad Nseir, MD,PhD
• Phone: 320 44 44 95
• Email: saad.nseir[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients hospitalized in the ICU

• suspected with VAP or HAP requiring MV

Exclusion Criteria:

• Severe immunodeficiency

• Moribund patients (SAPS II > 90)

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Ventilator-Associated

Intervention

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

Locations

Country	Name	City	State
France	CHU Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Curetis GmbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of Patient Deaths	number of patient deaths after antibiotics start	at 28 days after antibiotics start
Secondary	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