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

NCT07267624 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: BASEC N° 2024-00369
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 5

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.

Conditions

VAP - Ventilator Associated Pneumonia; Antibiotic; Antibiotic Stewardship; Antibiotic Prescribing for Acute Respiratory-tract Infections; Intensive Care (ICU)

Keywords

ventilator Associated Pneumonia (VAP); antibiotic; PCR multiplex; intensive care; broad spectrum antibiotic; stewardship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

PCR multiplex BioFire Pneumonia plus DEVICE

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 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years old)
• Hospitalized in intensive care with invasive mechanical ventilation ≥ 48 hours
• Expected survival \> 96 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

University hospitals of Geneva, Division of Intensive Care

Geneva, Canton of Geneva, 1205, Switzerland

Location

Dept. of Intensive Care Medicine, University hospital of Lausanne

Lausanne, Switzerland

Location

Division of Intensive care, Hospital of Lugano

Lugano, Switzerland

Location

Division of Intensive care, Hospital of Neuchâtel

Neuchâtel, Switzerland

Location

Division of Intensive care, University hospital of Sion

Sion, Switzerland

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christophe Le Terrier, MD

CONTACT

+41795532741; christophe.leterrier@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator coordinator and Attending Physician in ICU

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: December 5, 2025
• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)