EARLY Antibiotics aDAptation in Severe Pneumonia(The EARLY ADAPT Study) (EARLY ADAPT)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Antibiotic Stewardship; Antibiotic; VAP - Ventilator Associated Pneumonia; Intensive Care (ICU); Antibiotic Prescribing for Acute Respiratory-tract Infections
• Intervention / Treatment: Device: PCR multiplex BioFire Pneumonia plus

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe Le Terrier, MD; Phone Number: +41795532741; Email: christophe.leterrier@hug.ch

Study Locations

• Switzerland
  • Lausanne, Switzerland
    • Dept. of Intensive Care Medicine, University hospital of Lausanne
    • Contact: Jean-Daniel CHICHE, MD, PhD; Phone Number: +41 79 5562393; Email: Jean-Daniel.Chiche@chuv.ch
    • Principal Investigator: Jean-Daniel CHICHE, MD, PhD
    • Sub-Investigator: Jean-Luc PAGANI, MD
  • Lugano, Switzerland
    • Division of Intensive care, Hospital of Lugano
    • Contact: Alberto Pagnamenta, MD; Phone Number: +41 91 811 64 82; Email: Alberto.Pagnamenta@eoc.ch
    • Principal Investigator: Alberto Pagnamenta, MD
  • Neuchâtel, Switzerland
    • Division of Intensive care, Hospital of Neuchâtel
    • Contact: Marie-Eve Brunner, MD; Phone Number: +41327133450
    • Principal Investigator: Marie-Eve Brunner, MD
  • Sion, Switzerland
    • Division of Intensive care, University hospital of Sion
    • Contact: Juan José García Martínez, MD; Phone Number: +4127 60 38357; Email: JuanJose.GarciaMartinez@hopitalvs.ch
    • Principal Investigator: Juan José García Martínez, MD
    • Sub-Investigator: Stéphane Emonet, MD, PhD
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1205
      • University hospitals of Geneva, Division of Intensive Care
      • Contact: Christophe Le Terrier, MD; Phone Number: +795532741; Email: christophe.leterrier@hug.ch
      • Principal Investigator: Christophe Le Terrier, MD
      • Sub-Investigator: Vivian Valiton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: PCR 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion	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.	Seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay		28 days
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.	I. Appropriate antimicrobial therapy is defined as follows: Susceptibility of the cultured micro-organisms to the empiric antibiotic regimen.; Narrowest spectrum II. Inappropriate antimicrobial therapy is defined as follows: Not active according to the in-vitro susceptibility testing of the identified pathogen.; Having a spectrum too broad for resistance pattern of the identified pathogen; 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	48 hours
ICU mortality and hospital mortality at Day 28		28 days
Ventilator free-days until Day 28		28 days
Rate of adherence to antimicrobial guidelines at 48h.	Rate of patients treated following the antimicrobial guidelines provided in the study.	48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: BioMérieux; Hospital Fribourg, Switzerland; Centre Hospitalier du Centre du Valais; Hospital Lugano; Hospital of Neuchâtel; Hôpital universitaire de Lausanne

Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: intensive care; antibiotic; PCR multiplex; ventilator Associated Pneumonia (VAP); broad spectrum antibiotic; stewardship
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: BASEC N° 2024-00369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because we would like to publish the IPD before sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes