search
Back to results

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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PCR based strategy
Standard care
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Ventilator-Associated focused on measuring Ventilator-associated pneumonia, Hospital-acquired pneumonia, Immunodeficiency, Antimicrobial therapy, Polymerase chain reaction (PCR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    PCR group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    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
    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
    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

    Full Information

    First Posted
    May 31, 2022
    Last Updated
    December 13, 2022
    Sponsor
    University Hospital, Lille
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05405491
    Brief Title
    Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation
    Acronym
    RESPIRE
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia, Ventilator-Associated, Pneumonia, Hospital-Acquired, Immunodeficiency
    Keywords
    Ventilator-associated pneumonia, Hospital-acquired pneumonia, Immunodeficiency, Antimicrobial therapy, Polymerase chain reaction (PCR)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PCR group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Intervention Type
    Other
    Intervention Name(s)
    PCR based strategy
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Intervention Description
    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 Measure Information:
    Title
    Increase in percentage of patients with targeted antibiotics
    Description
    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
    Time Frame
    24 hours after the initiation of empiric antimicrobial therapy
    Secondary Outcome Measure Information:
    Title
    Percentage of patients receiving appropriate anticrobial treatment
    Description
    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
    Time Frame
    24 hours after the initiation of empiric antimicrobial therapy
    Title
    Mechanical ventilation free days
    Description
    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
    Time Frame
    28 days after the initiation of empiric antimicrobial therapy
    Title
    ICU Length of stay
    Description
    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
    Time Frame
    Until 28 days after the initiation of empiric antimicrobial therapy
    Title
    28 days mortality
    Description
    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
    Time Frame
    28 days after the initiation of empiric antimicrobial therapy
    Title
    Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria
    Description
    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
    Time Frame
    28 days after the initiation of empiric antimicrobial therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marion HOUARD, MD
    Phone
    0320445962
    Ext
    +33
    Email
    marion.houard@chru-lille.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marion HOUARD, MD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs