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NCT Number: NCT04937075

Impact of Antimicrobial Stewardship on Outcomes of Patients With Hospital-acquired Pneumonia Due to Gram-negative Bacilli - A Before-after Study

Hospital-acquired pneumonia (HAP) is one of the most frequent complications and the main cause of antibiotics use in hospitalized patients, particularly in intensive care units (ICUs). The latest European and French recommendations for the management of HAP were published in 2017 and 2018. Gram-negative bacilli are frequently identified in this pneumonia.

The experts discussed the issue of tailored-empiric antimicrobial therapy. Because delayed antimicrobial therapy is associated with poor outcomes, their conclusion was to reduce the time to deliver proper antimicrobial therapy, but to limit over-use of broad-spectrum molecules. Since delays in microbiological identification hinder the ability of clinicians to streamline therapy, rapid diagnostic with multiplex PCR, which decreases the time to organism identification by 2 days compared to conventional methods, is appealing, especially for gram-negative bacilli. The FilmArray® Lower Respiratory Tract Infection Panel is a rapid multiplex PCR which tests for the most frequently pathogens (18 bacteria including plenty of gram-negative bacilli +5 genes of resistance, and 9 viruses) involved in HAP. The FilmArray® Lower Respiratory Tract Infection (LRTI) Panel has a sensitivity and a specificity of 95% and 99% respectively and can be implemented in a personalized antimicrobial guidance to treat HAP due to gram-negative bacilli. The investigators hypothesized that a rapid multiplex PCR for guidance of empiric antimicrobial therapy, especially for gram-negative bacilli, reduces the time-to-proper antimicrobial therapy and reduces the risk of death of patients suffering of HAP.

The investigators aim to assess the efficacy of an antimicrobial stewardship including the results of a rapid respiratory panel multiplex PCR for empiric antimicrobial guidance in patients with hospital-acquired pneumonia due to gram-negative bacilli.

The investigators will use a before-after design to test the efficiency of an antimicrobial stewardship including a highly innovative intervention.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Immunocompetent adult patients
  • Receiving mechanical ventilation
  • Suspected hospital-acquired pneumonia
  • Non-opposition from the patient or a relative.

Exclusion criteria

  • Pregnant women, breastfeeding-women
  • Minors, Adults under guardianship or trusteeship

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. To assess the effectiveness of access to empiric antibiotic therapy guided by Multiplex PCR in intensive care patients with hospital acquired pneumonia

    Time frame: 28 days

    Composite endpoints: survival on D28, number of days without mechanical ventilation on D28, and clinical recovery between D7 and D10 (RADAR method)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Impact of Antimicrobial Stewardship on Outcomes of Patients With Hospital-acquired Pneumonia Due to Gram-negative Bacilli - A Before-after ORACLE Study

Acronym: ORACLE

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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