NCT05205525

Brief Summary

This retro-prospective monocentric observational study compare the impact of the implementation of a restrictive (delayed) versus aggressive (immediate) antibiotic strategy for Ventilator Acquired Pneumonia suspicion without severity symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 6, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 11, 2022

Last Update Submit

March 7, 2023

Conditions

Ventilator Associated PneumoniaCritical CareAntibiotic Therapy

Outcome Measures

Primary Outcomes (1)

  • antibiotic-free days

    antibiotic-free days until Day 28 of Intensive Care Units stay

    28 days

Secondary Outcomes (4)

  • Mechanical ventilation free days

    28 days

  • Intensive care unit stay length

    28 days

  • Intensive care unit mortality

    28 days

  • Hospitality mortality

    28 days

Study Arms (2)

Restrictive antibiotic strategy

Other: Restrictive antibiotic strategy

Aggressive (immediate) antibiotic strategy

Other: Aggressive antibiotic strategy

Interventions

Restrictive antibiotic strategyOTHER

Implementation of a restrictive (delayed) antibiotic strategy in Ventilator Acquired Pneumonia suspicion without severity symptoms.

Restrictive antibiotic strategy
Aggressive antibiotic strategyOTHER

Implementation of an aggressive (immediate) antibiotic strategy in Ventilator Acquired Pneumonia suspicion without severity symptoms.

Aggressive (immediate) antibiotic strategy

Eligibility Criteria

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

patient under mechanical ventilation in intensive care with suspected ventilator acquired pneumonia

You may qualify if:

  • Under mechanical ventilation from more than 48 hours
  • Suspected for a ventilator acquired pneumonia, requiring a distal pulmonary bacterial sample

You may not qualify if:

  • New or worsening shock requiring vasopressor
  • New or worsening severe hypoxemia (PaO2/FiO2\<150 in FiO2≥60% and peep 10)
  • Patient under veno-veinous extracorporeal membrane oxygenation
  • Neutropenia \<1G/L or immunosuppressive treatment (including corticosteroids \>6 months or \>0.5mg/kg/j)
  • Disease (endocarditis, spondylodyscitis, deep abcedation…) requiring prolonged antibiotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Nantes Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 25, 2022

Study Start

January 6, 2022

Primary Completion

January 28, 2023

Study Completion

January 28, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

FR(1)