Ventilator Associated PneumoniaPETUNIANCT06243094
Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA)
An observational study of Ventilator Associated Pneumonia, run by French Society for Intensive Care at 1 site in France.
Trial summary
The French Society of Intensive Care conducts a comprehensive assessment of current antibiotic therapy practices in critically ill patients suspected of Ventilator-Associated Pneumonia (VAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Antibiotic
- How many people
- 1,060 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2024to 12 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants in this study will be ICU patients, undergoing invasive mechanical ventilation > 48h, for whom antibiotic therapy is initiated to treat a suspicion of Ventilator-Associated Pneumonia (VAP).
Who may be able to join
- Age ≥ 18 years
- Admission to the ICU
- Intubation and duration of invasive mechanical ventilation > 48 hours
- Initiation of new antibiotic therapy to treat a first suspicion of Ventilator-Associated Pneumonia (VAP)
Who cannot join
- Presence of a decision to limit active therapeutic measures at the time of initiating antibiotic therapy
- Organ donor
- Prior inclusion in the study during a previous stay in the intensive care unit (a patient cannot be included multiple times)
- Participation in an interventional study focusing on the management of VAP and directly impacting antibiotic therapy practices
- Patient and/or family opposition to participation
- Lack of affiliation with a social security system
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Lille university hospital
Lille, Haut de France, 59000
Anahita Rouzé, MD
Anahita Rouzé, MD
About this study
Official title: Survey on Antibiotic Therapy Practices for Ventilator-Associated Pneumonia in ICU Patients
The French Society of Intensive Care conducts a comprehensive assessment of current antibiotic therapy practices in critically ill patients suspected of Ventilator-Associated Pneumonia (VAP).
Read the detailed description
This prospective observational multicenter study will be conducted in intensive care units (ICU) across France and French-speaking regions. The primary objective of this study is to delineate the characteristics of antibiotic treatments administered for a first episode of suspected VAP. Secondary objectives include describing the outcomes of enrolled patients, assessing adherence to European guidelines regarding empirical antibiotic treatment, and identifying factors associated with mortality in patients with microbiologically confirmed VAP.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Antibiotic
- Keywords
- antibiotic, intensive care, guidelines, outcome
- 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.
AntibioticDrug
Also called antimicrobial therapy
All antibiotic therapy characteristics are monitored.
| Study group | Role | What they receive |
|---|---|---|
| microbiologically confirmed VAP | patients who meet ATS/IDSA 2005 VAP criteria with microbiological confirmation Receives: Drug: Antibiotic | |
| non microbiologically confirmed VAP | patients who do not meet ATS/IDSA 2005 criteria with microbiological confirmation Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of Initial Antibiotic Treatment
Empirical / guided / directly targeted Monotherapy or combination therapy Monotherapy or combination therapy against resistant GNB Addition of an antibiotic active against Methicillin-Resistant Staphylococcus aureus Molecule(s) and class(es) of antibiotics Time from the onset of suspected VAP to initiation of initial antibiotic treatment Total dose in the first 24 hours for each molecule Administration modalities in the first 24 hours for each molecule Conducting plasma level measurements Appropriate treatment (in patients with microbiologically confirmed VAP) Time from the onset of suspected VAP to initiation of appropriate antibiotic treatment (in patients with microbiologically confirmed VAP)
Note for the reviewer: our study is descriptive, and multiple characteristics of initial antibiotic treatment have been validated by the institutional review board and methodologist, as a descriptive outcome.
Measured: 3 days
Characteristics of Definitive Antibiotic Treatment (for patients alive at Day 3 only)
Monotherapy or combination therapy Molecule(s) and class(es) of antibiotics Broadening of antibiotic spectrum Discontinuation of all antibiotics (prescribed for VAP treatment) at Day 3 and Day 5 Antibiotic de-escalation at Day 3 and Day 5 by reducing the spectrum of an initial antibiotic or by discontinuing a component of an initial combination of antibiotics
Note for the reviewer: our study is descriptive, and multiple characteristics of definite antibiotic treatment have been validated by the institutional review board and methodologist, as a descriptive outcome.
Measured: 7 days
Total Duration of Appropriate Treatment
Total Duration of Appropriate Treatment for the episode of VAP
Measured: ICU stay (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start12 Mar 2024 (estimated)
- Primary completion12 Mar 2025 (estimated)
- Study completion12 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahita Rouzé, MD, Principal investigator, French Intensive Care Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243094
- Sponsor's protocol ID
- 2023-A01492-43
- Acronym
- PETUNIA
- Status last verified
- Mar 2024
- First submitted
- 19 Jan 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Antibiotic Therapy Practices for Ventilator-Associated Pneumonia in ICU Patients
- ClinicalTrials.gov ID
- NCT06243094
- Acronym / sponsor ID
- PETUNIA / 2023-A01492-43
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- antibiotic, intensive care, guidelines, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,060 participants (estimated)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Study start
- 12 Mar 2024 (estimated)
- Primary completion
- 12 Mar 2025 (estimated)
- Study completion
- 12 Mar 2025 (estimated)
- First posted
- 6 Feb 2024 (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 French Society of Intensive Care conducts a comprehensive assessment of current antibiotic therapy practices in critically ill patients suspected of Ventilator-Associated Pneumonia (VAP).
Detailed description
This prospective observational multicenter study will be conducted in intensive care units (ICU) across France and French-speaking regions. The primary objective of this study is to delineate the characteristics of antibiotic treatments administered for a first episode of suspected VAP. Secondary objectives include describing the outcomes of enrolled patients, assessing adherence to European guidelines regarding empirical antibiotic treatment, and identifying factors associated with mortality in patients with microbiologically confirmed VAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microbiologically confirmed VAP | – | Drug: Antibioticpatients who meet ATS/IDSA 2005 VAP criteria with microbiological confirmation |
| non microbiologically confirmed VAP | – | Drug: Antibioticpatients who do not meet ATS/IDSA 2005 criteria with microbiological confirmation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will be ICU patients, undergoing invasive mechanical ventilation > 48h, for whom antibiotic therapy is initiated to treat a suspicion of Ventilator-Associated Pneumonia (VAP).
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Admission to the ICU
- Intubation and duration of invasive mechanical ventilation > 48 hours
- Initiation of new antibiotic therapy to treat a first suspicion of Ventilator-Associated Pneumonia (VAP)
Key exclusion criteria (6 listed)
- Presence of a decision to limit active therapeutic measures at the time of initiating antibiotic therapy
- Organ donor
- Prior inclusion in the study during a previous stay in the intensive care unit (a patient cannot be included multiple times)
- Participation in an interventional study focusing on the management of VAP and directly impacting antibiotic therapy practices
- Patient and/or family opposition to participation
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 |
|---|---|---|
| AntibioticAlso: antimicrobial therapyAll antibiotic therapy characteristics are monitored. | Drug | microbiologically confirmed VAP, non microbiologically confirmed VAP |
Primary outcome
Characteristics of Initial Antibiotic Treatment
Time frame: 3 days
Empirical / guided / directly targeted Monotherapy or combination therapy Monotherapy or combination therapy against resistant GNB Addition of an antibiotic active against Methicillin-Resistant Staphylococcus aureus Molecule(s) and class(es) of antibiotics Time from the onset of suspected VAP to initiation of initial antibiotic treatment Total dose in the first 24 hours for each molecule Administration modalities in the first 24 hours for each molecule Conducting plasma level measurements Appropriate treatment (in patients with microbiologically confirmed VAP) Time from the onset of suspected VAP to initiation of appropriate antibiotic treatment (in patients with microbiologically confirmed VAP) Note for the reviewer: our study is descriptive, and multiple characteristics of initial antibiotic treatment have been validated by the institutional review board and methodologist, as a descriptive outcome.
Characteristics of Definitive Antibiotic Treatment (for patients alive at Day 3 only)
Time frame: 7 days
Monotherapy or combination therapy Molecule(s) and class(es) of antibiotics Broadening of antibiotic spectrum Discontinuation of all antibiotics (prescribed for VAP treatment) at Day 3 and Day 5 Antibiotic de-escalation at Day 3 and Day 5 by reducing the spectrum of an initial antibiotic or by discontinuing a component of an initial combination of antibiotics Note for the reviewer: our study is descriptive, and multiple characteristics of definite antibiotic treatment have been validated by the institutional review board and methodologist, as a descriptive outcome.
Total Duration of Appropriate Treatment
Time frame: ICU stay (up to 28 days)
Total Duration of Appropriate Treatment for the episode of VAP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
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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. This study is not recruiting at the moment.
Anahita Rouzé, MD principal investigator
French Intensive Care Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by French Society for Intensive Care at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anahita Rouzé, MD (0033 3 20 44 40 84, anahita.rouze@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of Initial Antibiotic Treatment (time frame: 3 days). The study lists 3 primary outcomes in all. 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 15 Mar 2024.