Immunodeficiency, Pneumonia, Hospital-Acquired, Pneumonia, Ventilator-Associated
Conditions
Keywords
Ventilator-associated pneumonia, Hospital-acquired pneumonia, Immunodeficiency, Antimicrobial therapy, Polymerase chain reaction (PCR)
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
Interventions
OTHERPCR 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
OTHERStandard 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
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in percentage of patients with targeted antibiotics | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients receiving appropriate anticrobial treatment | 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 |
| Mechanical ventilation free days | 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 |
| ICU Length of stay | 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 |
| 28 days mortality | 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 |
| Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria | 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 |
Countries
France
Contacts
CONTACTMarion HOUARD, MD
PRINCIPAL_INVESTIGATORMarion HOUARD, MD
University Hospital, Lille
Outcome results
None listed