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
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
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
NCT ID
NCT05405491
First Posted
May 31, 2022
Last Updated
December 13, 2022
Sponsor
University Hospital, Lille
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
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