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NCT Number: NCT07267624

EARLY Antibiotics aDAptation in Severe Pneumonia(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.

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Key information

Conditions

VAP - Ventilator Associated Pneumonia Antibiotic Antibiotic Prescribing for Acute Respiratory-tract Infections Antibiotic Stewardship Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Intensive Care (ICU) Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospitals of Geneva, Division of Intensive Care, Geneva, Canton of Geneva, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Median time (in hours) on broad-spectrum antibiotics during ICU stay.

    Time frame: 28 days

  2. Antibiotic free days defined as the number of days alive without antibiotics at Day 14 and Day 28.

    Time frame: 28 days

  3. Time to antimicrobial switch (time to de-escalation or escalation) measured in hours.

    Time frame: Seven days

  4. Rate of appropriate antimicrobial therapy at the following time points: inclusion, 24h after inclusion and 48h after inclusion.

    Time frame: 48 hours

    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

  5. ICU mortality and hospital mortality at Day 28

    Time frame: 28 days

  6. Ventilator free-days until Day 28

    Time frame: 28 days

  7. ICU length of stay

    Time frame: 28 days

  8. Rate of adherence to antimicrobial guidelines at 48h.

    Time frame: 48 hours

    Rate of patients treated following the antimicrobial guidelines provided in the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Le Terrier, MD

CONTACT

[email protected]

+41795532741

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • BioMérieux
  • Centre Hospitalier du Centre du Valais
  • Hospital Fribourg, Switzerland
  • Hospital Lugano
  • Hospital of Neuchâtel
  • Hôpital universitaire de Lausanne

Registry information

Official study title

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.

Acronym: EARLY ADAPT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 5, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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