Pneumonia Ventilator AssociatedPAVM-RéaCHSFNCT07181824
VAP Incidence and Adequation to SRLF 2017 Diagnostic Among an Intensive Care Medicine Service for the Period 2022 à 2024
An observational study of Pneumonia Ventilator Associated, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The goal of this observational study is to to analyze respiratory samples performed in mechanically ventilated ICU patients and to assess whether the SRLF criteria for defining VAP were respected among patients admited to the Intensive care medicine at a regional hospital en France Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia Ventilator Associated
- What is being tested?
- Diagnostic tedst
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2025to 30 Jun 2026
- Phase
- Observational
- 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
Study population: Population includes all patients admitted to the intensive care unit for the selected period, under mechanical ventilation.
Who may be able to join
- Adults ≥ 18 years
- Hospitalization in Intensive care unit for the period between 01/01/2022 and 31/12/2024
- Intubation and mechanical ventilation for > 48h
- Positive respiratory sample
Who cannot join
- Decision of therapeutic limitation
- Organ donors
- Patient refuse to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Luis ENSENYAT MARTIN, MD, 33 1 61 69 31 57 ext. 33, luis.ensenyatmartin@chsf.fr
Abdoul DINE, 33 1 61 69 31 57 ext. 33, abdl_dine@hotmail.fr
About this study
The goal of this observational study is to to analyze respiratory samples performed in mechanically ventilated ICU patients and to assess whether the SRLF criteria for defining VAP were respected among patients admited to the Intensive care medicine at a regional hospital en France
Read the detailed description
Ventilator-associated pneumonia (VAP) is a lung infection that occurs after more than 48 hours of mechanical ventilation. It is of particular interest because it affects between 5-40% of ICU patients depending on the study and diagnostic criteria, with a relatively low attributable mortality (around 10%), but with increased morbidity, notably in terms of the duration of mechanical ventilation and ICU length of stay. In addition, it is the leading cause of nosocomial infection in the ICU, accounting for up to 25% of antibiotic use for hospital-acquired infections.
The diagnosis of VAP is based on clinico-radiological criteria: the appearance or worsening of a radiological pulmonary infiltrate, an inflammatory syndrome, the appearance of secretions, increased oxygen dependency and/or worsening of shock, confirmed by a positive respiratory sample.
The diagnostic challenge lies in the fact that the signs and symptoms are not pathognomonic of VAP and may be common to other conditions. On the other hand, patients may be colonized by pathogens without actually having VAP.
For this reason, scientific societies propose criteria to better target patients for whom a respiratory sample should be taken and antibiotic therapy initiated.
In 2017, the French Society of Intensive Care Medicine (SRLF) and the French Society of Anaesthesia and Intensive Care (SFAR) published recommendations on ICU-associated pneumonia, with some minor variations compared with the 2005 ATS/IDSA criteria.
Our study aims to analyze respiratory samples performed in mechanically ventilated ICU patients and to assess whether the SRLF criteria for defining VAP were respected.
- Conditions
- Pneumonia Ventilator Associated
- Being tested
- Diagnostic tedst
- Keywords
- Ventilatory associated pneumonia, VAP, Intensive Care medicine, Mechanical ventilation, Pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic tedstOther
- Radiologic signs: 2 consecutive thorax x-ray with new onset pneumonia AND
- One of the following criteria
- Fever >38,3°C without any other cause
- Leucocytes < 4000/mm3 or ≥ 12000 /mm3
- AND at least two of the following
- Purulent secretions
- Cough or dyspnoea
- Desaturation or increase in FiO2 (+20%)
| Study group | Role | What they receive |
|---|---|---|
| VAP suspicion | Adult patients (>18 years) under mechanical ventilation for >48 hours and with a positive respiratory sample Receives: Other: Diagnostic tedst |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRLF VAP criteria
Describe whether the respiratory samples obtained from ICU patients after >48 hours of mechanical ventilation for suspected VAP met, or did not meet, the 2017 SRLF diagnostic criteria
Measured: at day 0
Secondary outcomes (6)
microbial ecology in the ICU of CHSF
Prevalence of MDR in the respiratory samples
Measured: at day 0
antibiotic consumption generated by VAP
To evaluate antibiotic consuming related to VAP episodes to the total antibiotic consuming in the Intensive care unit
Measured: at day 0
morbidity and mortality associated with VAP
Mortality and mechanical ventilation duration among patients diagnosed of VAP
Measured: at day 0
duration of antibiotic therapy for a VAP episode
Duration of antibiotherapy among patients with VAP
Measured: at day 0
characteristics of the initial antibiotic therapy
Number and class of antibiotics of the initial antibiotic therapy
Measured: at day 0
Evaluate the adequacy of the initial antibiotic therapy
Adequation of the initial therapy compared to the definitive therapy: maintain, increase or reduce the spectrum or number of antibiotics
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start25 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia Ventilator AssociatedStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis ENSENYAT MARTIN, MD, Principal investigator, Centre Hospitalier Sud FrancilienAbdoul DINE, Study director, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181824
- Sponsor's protocol ID
- 2025/0025
- Acronym
- PAVM-RéaCHSF
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAP Incidence and Adequation to SRLF 2017 Diagnostic Among an Intensive Care Medicine Service for the Period 2022 à 2024
- ClinicalTrials.gov ID
- NCT07181824
- Acronym / sponsor ID
- PAVM-RéaCHSF / 2025/0025
- Conditions
- Pneumonia Ventilator Associated
- Keywords
- Ventilatory associated pneumonia, VAP, Intensive Care medicine, Mechanical ventilation, Pneumonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Sep 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 goal of this observational study is to to analyze respiratory samples performed in mechanically ventilated ICU patients and to assess whether the SRLF criteria for defining VAP were respected among patients admited to the Intensive care medicine at a regional hospital en France
Detailed description
Ventilator-associated pneumonia (VAP) is a lung infection that occurs after more than 48 hours of mechanical ventilation. It is of particular interest because it affects between 5-40% of ICU patients depending on the study and diagnostic criteria, with a relatively low attributable mortality (around 10%), but with increased morbidity, notably in terms of the duration of mechanical ventilation and ICU length of stay. In addition, it is the leading cause of nosocomial infection in the ICU, accounting for up to 25% of antibiotic use for hospital-acquired infections.
The diagnosis of VAP is based on clinico-radiological criteria: the appearance or worsening of a radiological pulmonary infiltrate, an inflammatory syndrome, the appearance of secretions, increased oxygen dependency and/or worsening of shock, confirmed by a positive respiratory sample.
The diagnostic challenge lies in the fact that the signs and symptoms are not pathognomonic of VAP and may be common to other conditions. On the other hand, patients may be colonized by pathogens without actually having VAP.
For this reason, scientific societies propose criteria to better target patients for whom a respiratory sample should be taken and antibiotic therapy initiated.
In 2017, the French Society of Intensive Care Medicine (SRLF) and the French Society of Anaesthesia and Intensive Care (SFAR) published recommendations on ICU-associated pneumonia, with some minor variations compared with the 2005 ATS/IDSA criteria.
Our study aims to analyze respiratory samples performed in mechanically ventilated ICU patients and to assess whether the SRLF criteria for defining VAP were respected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAP suspicion | – | Other: Diagnostic tedstAdult patients (>18 years) under mechanical ventilation for >48 hours and with a positive respiratory sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population includes all patients admitted to the intensive care unit for the selected period, under mechanical ventilation.
Key inclusion criteria (4 listed)
- Adults ≥ 18 years
- Hospitalization in Intensive care unit for the period between 01/01/2022 and 31/12/2024
- Intubation and mechanical ventilation for > 48h
- Positive respiratory sample
Key exclusion criteria (3 listed)
- Decision of therapeutic limitation
- Organ donors
- Patient refuse to participate
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 |
|---|---|---|
| Diagnostic tedst* Radiologic signs: 2 consecutive thorax x-ray with new onset pneumonia AND * One of the following criteria * Fever >38,3°C without any other cause * Leucocytes < 4000/mm3 or ≥ 12000 /mm3 * AND at least two of the following * Purulent secretions * Cough or dyspnoea * Desaturation or increase in FiO2 (+20%) | Other | VAP suspicion |
Primary outcome
SRLF VAP criteria
Time frame: at day 0
Describe whether the respiratory samples obtained from ICU patients after >48 hours of mechanical ventilation for suspected VAP met, or did not meet, the 2017 SRLF diagnostic criteria
6 secondary outcomes
microbial ecology in the ICU of CHSF
Time frame: at day 0
antibiotic consumption generated by VAP
Time frame: at day 0
morbidity and mortality associated with VAP
Time frame: at day 0
duration of antibiotic therapy for a VAP episode
Time frame: at day 0
characteristics of the initial antibiotic therapy
Time frame: at day 0
Evaluate the adequacy of the initial antibiotic therapy
Time frame: at day 0
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 9 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Pneumonia Ventilator Associated
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
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.
Luis ENSENYAT MARTIN, MD principal investigator
Centre Hospitalier Sud Francilien
Abdoul DINE study director
Centre Hospitalier Sud Francilien
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 Pneumonia Ventilator Associated, run by Centre Hospitalier Sud Francilien 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 3 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. 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?
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 Luis ENSENYAT MARTIN, MD (33 1 61 69 31 57 ext. +33, luis.ensenyatmartin@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SRLF VAP criteria (time frame: at day 0). 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 9 Dec 2025.