VAP Incidence and Adequation to SRLF 2017 Diagnostic Among an Intensive Care Medicine Service for the Period 2022 à 2024

NCT ID: NCT07181824

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2026-06-30

Brief 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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

VAP suspicion

Adult patients (\>18 years) under mechanical ventilation for \>48 hours and with a positive respiratory sample

Diagnostic tedst

Intervention Type: OTHER

• 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%)

Interventions

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%)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Decision of therapeutic limitation
• Organ donors
• Patient refuse to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis ENSENYAT MARTIN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Abdoul DINE

Role: STUDY_DIRECTOR

Centre Hospitalier Sud Francilien

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Luis ENSENYAT MARTIN, MD

Role: CONTACT

luis.ensenyatmartin@chsf.fr

33 1 61 69 31 57 ext. +33

Caroline TOURTE

Role: CONTACT

caroline.tourte@chsf.fr

33 1 61 69 31 50 ext. +33

Facility Contacts

Luis ENSENYAT MARTIN, MD

Role: primary

luis.ensenyatmartin@chsf.fr

33 1 61 69 31 57 ext. 33

Abdoul DINE

Role: backup

abdl_dine@hotmail.fr

33 1 61 69 31 57 ext. 33

Other Identifiers

2025/0025

Identifier Type: -

Identifier Source: org_study_id