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Completed

NCT Number: NCT05205525

Delayed Antibiotic Therapy in Non-severe Ventilator Acquired Pneumonia (VAP)

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.

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Key information

About this study

Ventilator acquired pneumonia (VAP) is the leading cause of nosocomial infection in intensive care patients, and has been associated with increased antibiotic consumption, increased morbidity and mortality. VAP diagnosis is difficult due to subjective or non-specific criteria. Delaying antibiotic treatment for VAP suspicion without severity symptoms raises question since the probability of VAP diagnosis, as well as the risk of delaying treatment, is very uncertain. It may nonetheless limit the environmental impact of antibiotic use which is a public health concern. We compared antibiotic sparing and patient outcome, before and after the implementation of a restrictive (delayed) antibiotic strategy versus an aggressive (immediate) antibiotic strategy in VAP suspicion without severity symptoms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Restrictive antibiotic strategy

Other

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

Aggressive antibiotic strategy

Other

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

Primary outcomes

  1. antibiotic-free days

    Time frame: 28 days

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

Secondary outcomes

  1. Mechanical ventilation free days

    Time frame: 28 days

    Mechanical ventilation free days during the first 28 days

  2. Intensive care unit stay length

    Time frame: 28 days

  3. Intensive care unit mortality

    Time frame: 28 days

  4. Hospitality mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Aggressive Versus Restrictive Initiation of Antimicrobial Treatment in Critically Ill Patients With Suspected Ventilator Acquired Pneumonia Without Severity : a Before and After Observational Study

Acronym: DELAVAP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2022
Registry last updated
Mar 8, 2023

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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