VAP Incidence and Adequation to SRLF 2017 Diagnostic Amon... | NCT07181824

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

NCT07181824

Sponsor

Centre Hospitalier Sud Francilien

Status

Recruiting

Last Update Posted

Dec 9, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pneumonia Ventilator Associated

Interventions

Diagnostic tedst

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Sep 12, 2025

First Submission Date that Met QC Criteria

Sep 12, 2025

First Posted Date

Sep 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2025

Last Update Posted Date

Dec 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VAP suspicion		Adult patients (>18 years) under mechanical ventilation for >48 hours and with a positive respiratory sample	Other: Diagnostic tedst

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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%)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	at day 0

Secondary Outcomes

Measure	Description	Time Frame
microbial ecology in the ICU of CHSF	Prevalence of MDR in the respiratory samples	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Population includes all patients admitted to the intensive care unit for the selected period, under mechanical ventilation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luis ENSENYAT MARTIN, MD	Contact	33 1 61 69 31 57	+33	luis.ensenyatmartin@chsf.fr
Caroline TOURTE	Contact	33 1 61 69 31 50	+33	caroline.tourte@chsf.fr

Overall Officials

Name	Affiliation	Role
Luis ENSENYAT MARTIN, MD	Centre Hospitalier Sud Francilien	Principal Investigator
Abdoul DINE	Centre Hospitalier Sud Francilien	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Sud Francilien	Recruiting	Corbeil-Essonnes	France	91100	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053717	Pneumonia, Ventilator-Associated
D011014	Pneumonia

Ancestor Terms

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D012141	Respiratory Tract Infections

Browse Leaves

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Browse Branches

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