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

NCT04937075 | Completed

• 1 other identifier: RC21_0066
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hospital-acquired Pneumonia

Outcome Measures

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

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

  28 days

Study Arms (2)

Before period without multiplex PCR identification

Other: No intervention

After period with multiplex PCR identification

Other: No intervention

Interventions

No intervention OTHER

No intervention

After period with multiplex PCR identification; Before period without multiplex PCR identification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will include 400 patients hospitalized in intensive care units, under mechanical ventilation, with a suspected hospital-acquired pneumonia : 200 patients in the retrospective "before" phase, 200 patients in the prospective "after" phase with the PCR multiplex identification

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU de Nantes

Nantes, France

Location

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 23, 2021
• Study Start: June 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: January 15, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-01

Locations

FR (2)