VAP - Ventilator Associated PneumoniaEARLY ADAPTNCT07267624
EARLY Antibiotics aDAptation in Severe Pneumonia(The EARLY ADAPT Study)
A study testing PCR multiplex BioFire Pneumonia plus in people with VAP - Ventilator Associated Pneumonia and Antibiotic, run by University Hospital, Geneva at 5 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia, Antibiotic, Antibiotic Stewardship
- What is being tested?
- PCR multiplex BioFire Pneumonia plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 5 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Switzerland5 sites
University hospitals of Geneva, Division of Intensive Care
Geneva, Canton of Geneva, 1205
Christophe Le Terrier, MD, +795532741, christophe.leterrier@hug.ch
Christophe Le Terrier, MD
Dept. of Intensive Care Medicine, University hospital of Lausanne
Lausanne
Jean-Daniel CHICHE, MD, PhD, +41 79 5562393, Jean-Daniel.Chiche@chuv.ch
Jean-Daniel CHICHE, MD, PhD
Division of Intensive care, Hospital of Lugano
Lugano
Alberto Pagnamenta, MD, +41 91 811 64 82, Alberto.Pagnamenta@eoc.ch
Alberto Pagnamenta, MD
Division of Intensive care, Hospital of Neuchâtel
Neuchâtel
Marie-Eve Brunner, MD, +41327133450
Marie-Eve Brunner, MD
Division of Intensive care, University hospital of Sion
Sion
Juan José García Martínez, MD, +4127 60 38357, JuanJose.GarciaMartinez@hopitalvs.ch
Juan José García Martínez, MD
About this study
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.
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)
- Being tested
- PCR multiplex BioFire Pneumonia plus
- Keywords
- ventilator Associated Pneumonia (VAP), antibiotic, PCR multiplex, intensive care, broad spectrum antibiotic, stewardship
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR multiplex BioFire Pneumonia plusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PCR multiplex BioFire Pneumonia plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seven days
Secondary outcomes (8)
Median time (in hours) on broad-spectrum antibiotics during ICU stay.
Measured: 28 days
Antibiotic free days defined as the number of days alive without antibiotics at Day 14 and Day 28.
Measured: 28 days
Time to antimicrobial switch (time to de-escalation or escalation) measured in hours.
Measured: Seven days
Rate of appropriate antimicrobial therapy at the following time points: inclusion, 24h after inclusion and 48h after inclusion.
- 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
Measured: 48 hours
ICU mortality and hospital mortality at Day 28
Measured: 28 days
Ventilator free-days until Day 28
Measured: 28 days
ICU length of stay
Measured: 28 days
Rate of adherence to antimicrobial guidelines at 48h.
Rate of patients treated following the antimicrobial guidelines provided in the study.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start5 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux, Hospital Fribourg, Switzerland, Hôpital universitaire de Lausanne, Hospital of Neuchâtel, Centre Hospitalier du Centre du Valais, Hospital Lugano
- Responsible party
- Principal investigator, Christophe Le Terrier, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267624
- Sponsor's protocol ID
- BASEC N° 2024-00369
- Acronym
- EARLY ADAPT
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Because we would like to publish the IPD before sharing.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07267624
- Acronym / sponsor ID
- EARLY ADAPT / BASEC N° 2024-00369
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- BioMérieux, Hospital Fribourg, Switzerland, Hôpital universitaire de Lausanne, Hospital of Neuchâtel, Centre Hospitalier du Centre du Valais, Hospital Lugano
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: PCR multiplex BioFire Pneumonia plusIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR multiplex BioFire Pneumonia plusIn 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 | Intervention Group |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Because we would like to publish the IPD before sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCR multiplex BioFire Pneumonia plus in people with VAP - Ventilator Associated Pneumonia and Antibiotic, run by University Hospital, Geneva at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Le Terrier, MD (+41795532741, christophe.leterrier@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the broad-spectrum antibiotic-free hours at day 7 from inclusion (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.