Clinical trial NCT05405491: Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation
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
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia, Ventilator-Associated
Pneumonia, Hospital-Acquired
Immunodeficiency
Keywords: Ventilator-associated pneumonia
Hospital-acquired pneumonia
Immunodeficiency
Antimicrobial therapy
Polymerase chain reaction (PCR)
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Increase in percentage of patients with targeted antibiotics
timeFrame: 24 hours after the initiation of empiric antimicrobial therapy
Secondary outcomes:
measure: Percentage of patients receiving appropriate anticrobial treatment
timeFrame: 24 hours after the initiation of empiric antimicrobial therapy
measure: Mechanical ventilation free days
timeFrame: 28 days after the initiation of empiric antimicrobial therapy
measure: ICU Length of stay
timeFrame: Until 28 days after the initiation of empiric antimicrobial therapy
measure: 28 days mortality
timeFrame: 28 days after the initiation of empiric antimicrobial therapy
measure: Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria
timeFrame: 28 days after the initiation of empiric antimicrobial therapy
Other outcomes:
Locations:
city: Lille
country: France
facility: Houard
Study officials:
affiliation: University Hospital, Lille
name: Marion HOUARD, MD
role: PRINCIPAL_INVESTIGATOR
References: