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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumonia, Ventilator-Associated; Immunodeficiency; Pneumonia, Hospital-Acquired
• Intervention / Treatment: Other: PCR based strategy; Other: Standard care

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Houard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group	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
Experimental: PCR group	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Marion HOUARD, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Hospital-acquired pneumonia; Immunodeficiency; Ventilator-associated pneumonia; Antimicrobial therapy; Polymerase chain reaction (PCR)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Immunologic Deficiency Syndromes; Pneumonia, Ventilator-Associated; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2021_0344; 2021-A02900-41 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No