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

NCT ID: NCT07267624

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

PCR multiplex BioFire Pneumonia plus

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioMérieux

INDUSTRY

Sponsor Role collaborator

Hospital Fribourg, Switzerland

UNKNOWN

Sponsor Role collaborator

Hôpital universitaire de Lausanne

UNKNOWN

Sponsor Role collaborator

Hospital of Neuchâtel

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier du Centre du Valais

OTHER

Sponsor Role collaborator

Hospital Lugano

UNKNOWN

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Christophe Le Terrier

Investigator coordinator and Attending Physician in ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospitals of Geneva, Division of Intensive Care

Geneva, Canton of Geneva, Switzerland

Site Status

Dept. of Intensive Care Medicine, University hospital of Lausanne

Lausanne, , Switzerland

Site Status

Division of Intensive care, Hospital of Lugano

Lugano, , Switzerland

Site Status

Division of Intensive care, Hospital of Neuchâtel

Neuchâtel, , Switzerland

Site Status

Division of Intensive care, University hospital of Sion

Sion, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Christophe Le Terrier, MD

Role: CONTACT

+41795532741

Facility Contacts

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Christophe Le Terrier, MD

Role: primary

+795532741

Jean-Daniel CHICHE, MD, PhD

Role: primary

+41 79 5562393

Alberto Pagnamenta, MD

Role: primary

+41 91 811 64 82

Marie-Eve Brunner, MD

Role: primary

+41327133450

Juan José García Martínez, MD

Role: primary

+4127 60 38357

Other Identifiers

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BASEC N° 2024-00369

Identifier Type: -

Identifier Source: org_study_id

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