EARLY Antibiotics aDaptation in Ventilator-Acquired-Pneumonia Treatment After Implementation of a Broad-Panel Respiratory Multiplex PCR Test: A Multicenter Randomized Control Trial Conducted In Swiss Intensive Care Units. The EARLY ADAPT Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University Hospital, Geneva
- Enrollment
- 170
- Locations
- 5
- Primary Endpoint
- The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion
Study Overview
Brief Summary
The objective of the study is to determine whether rapid multiplex PCR testing of respiratory samples can reduce exposure to broad-spectrum antibiotics in intensive care unit patients with suspected or confirmed ventilator-associated pneumonia, compared to standard diagnostic methods.
As secondary objectives, the investigators will study antibiotic management and overall antibiotic consumption, as well as escalation or de-escalation events. The investigators will study the potential clinical impact of using multiplex PCR to see if the length of stay in the intensive care unit is reduced, as well as the duration of mechanical ventilation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (≥ 18 years old)
- •Hospitalized in intensive care with invasive mechanical ventilation ≥ 48 hours
- •Administration of antimicrobial therapy for suspected VAP at the time of inclusion.
- •Expected survival > 96 hours.
Exclusion Criteria
- •Enrollment prior to the current trial
- •Participation in an interventional study on the management of AMR that has a direct impact on antibiotic therapy practices.
Arms & Interventions
Control Group
Care in the control group is based on international guidelines for the management of VAP and carried out in accordance with the local guidelines of each center. This includes respiratory samples with traditional cultures to identify pathogens associated with VAP.
Intervention Group
In the intervention arm, in addition to traditional cultures for identifying pathogens and their resistance, multiplex PCR will be performed on the patient's respiratory samples. Empirical antibiotic therapy will be directly adapted to the results of multiplex PCR according to the guidelines provided.
Intervention: PCR multiplex BioFire Pneumonia plus (Device)
Outcomes
Primary Outcomes
The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion
Time Frame: Seven days
It is defined as the time, measured in hours, that the patient is alive and not treated with broad-spectrum antibiotics (≥ class 4 of ß-lactam according to Weiss et al.) within a period during from the date of randomization to day 7 or earlier if ICU discharge.
Secondary Outcomes
- Median time (in hours) on broad-spectrum antibiotics during ICU stay.(28 days)
- Antibiotic free days defined as the number of days alive without antibiotics at Day 14 and Day 28.(28 days)
- Time to antimicrobial switch (time to de-escalation or escalation) measured in hours.(Seven days)
- Rate of appropriate antimicrobial therapy at the following time points: inclusion, 24h after inclusion and 48h after inclusion.(48 hours)
- ICU mortality and hospital mortality at Day 28(28 days)
- Ventilator free-days until Day 28(28 days)
- ICU length of stay(28 days)
- Rate of adherence to antimicrobial guidelines at 48h.(48 hours)
Investigators
Christophe Le Terrier
Investigator coordinator and Attending Physician in ICU
University Hospital, Geneva