Antibiotic, Antibiotic Prescribing for Acute Respiratory-tract Infections, Antibiotic Stewardship, Intensive Care (ICU), VAP - Ventilator Associated Pneumonia
Conditions
Keywords
ventilator Associated Pneumonia (VAP), antibiotic, PCR multiplex, intensive care, broad spectrum antibiotic, stewardship
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.
Interventions
DEVICEPCR multiplex BioFire Pneumonia plus
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.
Sponsors
University Hospital, Geneva
BioMérieux
Hospital Fribourg, Switzerland
Hôpital universitaire de Lausanne
Hospital of Neuchâtel
Centre Hospitalier du Centre du Valais
Hospital Lugano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | I. Appropriate antimicrobial therapy is defined as follows: 1. Susceptibility of the cultured micro-organisms to the empiric antibiotic regimen. 2. Narrowest spectrum II. Inappropriate antimicrobial therapy is defined as follows: 1. Not active according to the in-vitro susceptibility testing of the identified pathogen. 2. Having a spectrum too broad for resistance pattern of the identified pathogen 3. Known intrinsic resistance of the identified pathogen to the given antibiotic. If no pathogen identified, antibiotic treatment covering Gram-negative rods was considered too broad. These criteria have been selected and adapted by Darie AM et al. Lancet Respir Med. 2022 |
| 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 | Rate of patients treated following the antimicrobial guidelines provided in the study. |
Countries
Switzerland
Contacts
CONTACTChristophe Le Terrier, MD
Outcome results
None listed