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NCT Number: NCT05405491

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pneumonia, Ventilator-Associated Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Immune System Diseases Immunodeficiency Immunologic Deficiency Syndromes Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Hospital-Acquired Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houard

Lille, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PCR based strategy

Other

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

Standard care

Other

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 outcomes

  1. Increase in percentage of patients with targeted antibiotics

    Time frame: 24 hours after the initiation of empiric antimicrobial therapy

    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

Secondary outcomes

  1. Percentage of patients receiving appropriate anticrobial treatment

    Time frame: 24 hours after the initiation of empiric antimicrobial therapy

    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

  2. Mechanical ventilation free days

    Time frame: 28 days after the initiation of empiric antimicrobial therapy

    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

  3. ICU Length of stay

    Time frame: Until 28 days after the initiation of empiric antimicrobial therapy

    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

  4. 28 days mortality

    Time frame: 28 days after the initiation of empiric antimicrobial therapy

    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

  5. Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria

    Time frame: 28 days after the initiation of empiric antimicrobial therapy

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: RESPIRE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2022
Registry last updated
Dec 26, 2025

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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