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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Pneumonia, Ventilator-Associated, Pneumonia, Hospital-Acquired, Immunodeficiency

Intervention / Treatment
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* Other: PCR based strategy
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCR group<br> | Other: PCR based strategy<br>* 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<br>|
| Sham Comparator: Control group<br> | Other: Standard care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in percentage of patients with targeted antibiotics | To determine the impact of a PCR-based strategy on the increase in percentage of patients with targeted antibiotics regimen 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care | 24 hours after the initiation of empiric antimicrobial therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients receiving appropriate anticrobial treatment | To determine the impact of a PCR-based strategy on the percentage of patients receiving approriate antimicrobial treatment 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care | 24 hours after the initiation of empiric antimicrobial therapy | 
| Mechanical ventilation free days | To determine the impact of a PCR-based strategy on the amount of days alive and free from mechanical ventilation at day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care | 28 days after the initiation of empiric antimicrobial therapy | 
| ICU Length of stay | To determine the impact of a PCR-based strategy on the length of stay in the Intensive Care Unit in the experimental group compared to standard care | Until 28 days after the initiation of empiric antimicrobial therapy | 
| 28 days mortality | To determine the impact of a PCR-based strategy on the mortality at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care | 28 days after the initiation of empiric antimicrobial therapy | 
| Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria | To determine the impact of a PCR-based strategy on the incidence of ICU-acquired infections and ICU-acquired colonization involving multidrug resistant bacteria at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care | 28 days after the initiation of empiric antimicrobial therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilator-associated pneumonia, Hospital-acquired pneumonia, Immunodeficiency, Antimicrobial therapy, Polymerase chain reaction (PCR)