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NCT Number: NCT07181824

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

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

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Key information

Conditions

Pneumonia Ventilator Associated Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic tedst

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%)

Primary outcomes

  1. 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

Secondary outcomes

  1. microbial ecology in the ICU of CHSF

    Time frame: at day 0

    Prevalence of MDR in the respiratory samples

  2. antibiotic consumption generated by VAP

    Time frame: at day 0

    To evaluate antibiotic consuming related to VAP episodes to the total antibiotic consuming in the Intensive care unit

  3. morbidity and mortality associated with VAP

    Time frame: at day 0

    Mortality and mechanical ventilation duration among patients diagnosed of VAP

  4. duration of antibiotic therapy for a VAP episode

    Time frame: at day 0

    Duration of antibiotherapy among patients with VAP

  5. characteristics of the initial antibiotic therapy

    Time frame: at day 0

    Number and class of antibiotics of the initial antibiotic therapy

  6. Evaluate the adequacy of the initial antibiotic therapy

    Time frame: at day 0

    Adequation of the initial therapy compared to the definitive therapy: maintain, increase or reduce the spectrum or number of antibiotics

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline TOURTE

CONTACT

[email protected]

33 1 61 69 31 50 ext. +33

Luis ENSENYAT MARTIN, MD

CONTACT

[email protected]

33 1 61 69 31 57 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: PAVM-RéaCHSF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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