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

Critical Care Clinical Trial

— DELAVAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05205525
• Other study ID #: MR_DELAVAP
• Status: Completed
• Start date: January 6, 2022
• Est. completion date: January 28, 2023

Study information

• Verified date: March 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 28, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Therapy
• Critical Care
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

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

Locations

Country	Name	City	State
France	University Nantes Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antibiotic-free days	antibiotic-free days until Day 28 of Intensive Care Units stay	28 days
Secondary	Mechanical ventilation free days	Mechanical ventilation free days during the first 28 days	28 days
Secondary	Intensive care unit stay length		28 days
Secondary	Intensive care unit mortality		28 days
Secondary	Hospitality mortality		28 days