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Recruiting NCT05405491

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

No phase Interventional Pneumonia, Ventilator-Associated Pneumonia, Hospital-Acquired Immunodeficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCR based strategy, Standard care.
Who it may be relevant to
Registry conditions: Pneumonia, Ventilator-Associated, Pneumonia, Hospital-Acquired, Immunodeficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impact of a Strategy Based on the PCR Testing System on Appropriate and Targeted Antimicrobial Treatment in Immunocompromised Patients With Suspected Ventilator-associated Pneumonia or Hospital-acquired Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial

Overview

RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation (MV) in Intensive Care Unit (ICU). The gold-standard microbiological diagnostic method for pneumonia in the ICU is based on culture identification and antimicrobial susceptibility testing. Results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. We aim to measure the impact of a PCR-based strategy to improve the percentage of patients with VAP or HAP receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care

Interventions

  • Other PCR based strategy
    Early adjustment of antimicrobial therapy according to the results of a multiplex PCR-based testing, used in addition to standard microbiological culture of the tracheal aspirate, in immunocompromised patients with suspected VAP or HAP requiring MV
  • Other Standard care
    Broad-spectrum antimicrobial therapy adjustment after results of standard microbiological culture of the tracheal aspirate in immunocompromised patients with suspected VAP or HAP requiring MV

Primary outcome measures

  • Increase in percentage of patients with targeted antibiotics [Time frame: 24 hours after the initiation of empiric antimicrobial therapy]
Secondary outcome measures (5)
  • Percentage of patients receiving appropriate anticrobial treatment [Time frame: 24 hours after the initiation of empiric antimicrobial therapy]
  • Mechanical ventilation free days [Time frame: 28 days after the initiation of empiric antimicrobial therapy]
  • ICU Length of stay [Time frame: Until 28 days after the initiation of empiric antimicrobial therapy]
  • 28 days mortality [Time frame: 28 days after the initiation of empiric antimicrobial therapy]
  • Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria [Time frame: 28 days after the initiation of empiric antimicrobial therapy]

Eligibility criteria

Inclusion criteria

  • Adult immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV

Exclusion criteria

  • No immunodeficiency Moribund patients (SAPS II > 90) Pregnant women Refuse to participate to the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Houard — Lille

Identifiers

NCT: NCT05405491 · 2021_0344 · 2021-A02900-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗