Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care

NCT05124977 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2022-09-20

Last updated

2025-05-25

Condition(s) studied

Ventilator Associated Pneumonia

Investigational drug(s) / intervention(s)

Antimicrobial StewardshipStandard management

Antimicrobial Stewardship: Antimicrobial stewardship based on daily clinical assessment of clinical cure. Discontinuation of appropriate antibiotic therapy antibiotics if criteria of clinical cure of confirmed pneumonia are met. Intensivists will perform clinical assessment daily in order to decide on the pursuit or discontinuation of antibiotic therapy.

Standard management: Standard management: duration of appropriate antibiotic for confirmed pneumonia fixed for 7 days according to guidelines. In the control group, intensivists will perform clinical assessment daily, but the antibiotic will not be discontinued until 7 days whatever the clinical cure.

Study summary

Increasing emergence of multidrug resistant (MDR) bacteria worldwide is now considered one of the most urgent threats to global health. The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit (ICU) who received antibiotic treatment and for patients treated for ventilator associated pneumonia (VAP).

Reduction of use of antibiotics is a major point in the war against antimicrobial resistance. VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP.

Once the diagnosis of pneumonia under MV has been made, initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration. In the case of a good clinical response to treatment, it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia (CAP).

The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.

The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.

This study will be a prospective, national multicenter (31 centers), phase III, comparative randomized (1:1), single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms:

Experimental group: Antimicrobial stewardship based on daily clinical assessment of clinical cure.

Control group: standard management: duration of appropriate antibiotic therapy for confirmed VAP according to guidelines.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Diagnosis of microbiologically confirmed of first episode of VAP * Initial appropriate antibiotic therapy (whether empirical or not) * Written informed consent from the patient or a legal representative if appropriate. If absence of a legal representative the patient may be included in emergency procedure Definitive diagnosis of pneumonia (in agreement with international guidelines) is defined by association: * Patient under MV\>48 hours at the time of the microbiological sampling * New pulmonary infiltrate of which an infectious origin is strongly suspected * Worsening oxygenation * Have the following clinical criteria within the 24 hours prior to the first dose of antibiotic therapy * Purulent tracheal secretions * And at least 1 of the following : documented fever (body temperature \>38,3°C) or hypothermia (body temperature \<35°C) or white blood cell (WBC) count \>10,000 cells/mm3 or \<4,000 cells/mm3 * Microbiological criteria (positive quantitative culture of a lower respiratory tract (LRT): bronchoalveolar lavage fluid (BAL) (significant threshold ≥10\^4 colony-forming units/mL) or plugged telescopic catheter (PTC) (significant threshold ≥ 10\^3 colony-forming units/mL) or quantitative endotracheal aspirate (ETA) distal pulmonary secretion samples (significant threshold ≥10\^5 colony-forming units/mL) Exclusion Criteria: * Patient under selective decontamination of the digestive tract * Duration of antibiotic therapy prior to inclusion \> 72h (for any reason) appropriate to the germs found in the bacterial documentation of the first episode of VAP * Inclusion in another interventional study concerning antimicrobial strategies * Moribund (IGS II\>80) * Thoracic trauma with Abbreviated Injury Scale (AIS) thorax ≥ 3 * Severely immunocompromised patients (such as congenital immunodeficiency, neutropenia (\<1leucocyte/ml or \<0.5 neutrophil/ml) or acute hematologic malignancy or stem cell transplant, HIV infection with CD4 count below 200/mm3 * Patients undergoing immunosuppressive therapy and long term corticotherapy \> 0.5 mg/kg * VAP due to: Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, Carbapenem-resistant Enterobacteriaceae * VAP occurring in the context of co-infection of COVID-19 or other viral pneumonia (confirmed by RT-PCR) * Patients with empyema, necrotizing and abscessed pneumonia * Patients requiring extracorporeal oxygen therapy (ECMO), either veno-venous or veno-arterial * Pregnant women * No health insurance coverage

Primary outcome measure(s)

Investigate whether an AMS for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia — 28 days
The primary endpoint is a composite endpoint with non-inferiority criteria including: 1\. all-cause mortality (ACM) measured at day 28 after initiation of therapy
Investigate whether an AMS for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia — 28 days
The primary endpoint is a composite endpoint with non-inferiority criteria including: 2\. Treatment failure defined by new signs of pneumonia within 72 hours after the end antibiotic treatment at the test of cure visit
Investigate whether an AMS for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia — 28 days
The primary endpoint is a composite endpoint with non-inferiority criteria including: 3\. New episode of microbiologically confirmed VAP from 72H after the end of antibiotic treatment to day 28 after initiation of VAP antibiotic treatment

Trial sites (1)

Facility	City	Region	Status
Foucrier	Clichy-sous-Bois	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05124977 on ClinicalTrials.gov ↗ ← All trials in France