NCT07181824

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Aug 2025Jun 2026

Study Start

First participant enrolled

August 25, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

September 12, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

Ventilatory associated pneumoniaVAPIntensive Care medicineMechanical ventilationPneumonia

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • microbial ecology in the ICU of CHSF

    at day 0

  • antibiotic consumption generated by VAP

    at day 0

  • morbidity and mortality associated with VAP

    at day 0

  • duration of antibiotic therapy for a VAP episode

    at day 0

  • characteristics of the initial antibiotic therapy

    at day 0

  • +1 more secondary outcomes

Study Arms (1)

VAP suspicion

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

Other: Diagnostic tedst

Interventions

* 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%)

VAP suspicion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedPneumonia

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luis ENSENYAT MARTIN, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR
  • Abdoul DINE

    Centre Hospitalier Sud Francilien

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 18, 2025

Study Start

August 25, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations