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

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ClinicalTrials.gov Identifier: NCT03711331
Recruitment Status : Not yet recruiting
First Posted : October 18, 2018
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
Curetis GmbH
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Ventilator-Associated Pneumonia, Bacterial Other: Unyvero®-based strategy Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unyvero®-based strategy
patients benefiting from the new strategy based on the system Unyvero ®
Other: Unyvero®-based strategy
Early adjustment of antimicrobial therapy according to the results of the Unyvero® testing for patients suspected with VAP or HAP requiring MV.

Sham Comparator: Standard care
patients benefiting from usual standard care
Other: Standard care
Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results




Primary Outcome Measures :
  1. Percentage of patients with targeted antibiotics regimen 24 hours after starting antimicrobial therapy in the experimental group compared to control group [ Time Frame: 24 hours after the initiation of empiric antimicrobial therapy ]

Secondary Outcome Measures :
  1. Percentage of patients receiving appropriate antimicrobial therapy 24 hours after antibiotics initiation [ Time Frame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start ]
  2. Amount of days alive and free from mechanical ventilation at day 28 after antibiotics initiation. [ Time Frame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start ]
  3. Length of stay in Intensive Care Unit [ Time Frame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start ]
  4. Number of Patient Deaths [ Time Frame: at 28 days after antibiotics start ]
    number of patient deaths after antibiotics start

  5. number of patient deaths in ICU [ Time Frame: 24 hours after antibiotics start Daily until 7 days after antibiotics start 14 days after antibiotics start 28 days after antibiotics start ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711331


Contacts
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Contact: Saad Nseir, MD,PhD 320 44 44 95 ext +33 saad.nseir@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Curetis GmbH
Investigators
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Principal Investigator: Saad Nseir, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03711331     History of Changes
Other Study ID Numbers: 2017_37
2018-A00149-46 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
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
Additional relevant MeSH terms:
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Healthcare-Associated Pneumonia
Pneumonia, Bacterial
Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents