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

January 11, 2022 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Restrictive antibiotic strategy
Other: Restrictive antibiotic strategy
Implementation of a restrictive (delayed) antibiotic strategy in Ventilator Acquired Pneumonia suspicion without severity symptoms.
Aggressive (immediate) antibiotic strategy
Other: Aggressive antibiotic strategy
Implementation of an aggressive (immediate) antibiotic strategy in Ventilator Acquired Pneumonia suspicion without severity symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antibiotic-free days
Time Frame: 28 days
antibiotic-free days until Day 28 of Intensive Care Units stay
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation free days
Time Frame: 28 days
Mechanical ventilation free days during the first 28 days
28 days
Intensive care unit stay length
Time Frame: 28 days
28 days
Intensive care unit mortality
Time Frame: 28 days
28 days
Hospitality mortality
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Anticipated)

May 6, 2023

Study Completion (Anticipated)

December 6, 2023

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR_DELAVAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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