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

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05205525

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator Associated Pneumonia Critical Care Antibiotic Therapy	Other: Restrictive antibiotic strategy Other: Aggressive antibiotic strategy

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official 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

Actual Study Start Date :

Jan 6, 2022

Anticipated Primary Completion Date :

May 6, 2023

Anticipated Study Completion Date :

Dec 6, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Mechanical ventilation free days [28 days]
Mechanical ventilation free days during the first 28 days
Intensive care unit stay length [28 days]
Intensive care unit mortality [28 days]
Hospitality mortality [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Nantes Hospital	Nantes		France	44000

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT05205525

Other Study ID Numbers:

MR_DELAVAP

First Posted:

Jan 25, 2022

Last Update Posted:

Jan 25, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumonia

Pneumonia, Ventilator-Associated

Anti-Bacterial Agents

Antibiotics, Antitubercular

Study Results

No Results Posted as of Jan 25, 2022