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Not yet recruiting NCT07267624

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

No phase Interventional VAP - Ventilator Associated Pneumonia Antibiotic Antibiotic Stewardship Antibiotic Prescribing for Acute Respiratory-tract Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCR multiplex BioFire Pneumonia plus.
Who it may be relevant to
Registry conditions: VAP - Ventilator Associated Pneumonia, Antibiotic, Antibiotic Stewardship, Antibiotic Prescribing for Acute Respiratory-tract Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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

  • 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.

Primary outcome measures

  • The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion [Time frame: Seven days]
Secondary outcome measures (8)
  • Median time (in hours) on broad-spectrum antibiotics during ICU stay. [Time frame: 28 days]
  • Antibiotic free days defined as the number of days alive without antibiotics at Day 14 and Day 28. [Time frame: 28 days]
  • Time to antimicrobial switch (time to de-escalation or escalation) measured in hours. [Time frame: Seven days]
  • Rate of appropriate antimicrobial therapy at the following time points: inclusion, 24h after inclusion and 48h after inclusion. [Time frame: 48 hours]
  • ICU mortality and hospital mortality at Day 28 [Time frame: 28 days]
  • Ventilator free-days until Day 28 [Time frame: 28 days]
  • ICU length of stay [Time frame: 28 days]
  • Rate of adherence to antimicrobial guidelines at 48h. [Time frame: 48 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Switzerland · 5 centers
  • University hospitals of Geneva, Division of Intensive Care — Geneva
  • Dept. of Intensive Care Medicine, University hospital of Lausanne — Lausanne
  • Division of Intensive care, Hospital of Lugano — Lugano
  • Division of Intensive care, Hospital of Neuchâtel — Neuchâtel
  • Division of Intensive care, University hospital of Sion — Sion

Identifiers

NCT: NCT07267624 · BASEC N° 2024-00369

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗