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

NCT ID: NCT03711331

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia, Ventilator-Associated Pneumonia, Bacterial

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

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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

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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

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Curetis GmbH

INDUSTRY

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saad Nseir, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHU Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Saad Nseir, MD,PhD

Role: CONTACT

Phone: 320 44 44 95

Email: [email protected]

References

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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 DERIVED
PMID: 33395094 (View on PubMed)

Other Identifiers

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2018-A00149-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017_37

Identifier Type: -

Identifier Source: org_study_id