Informations générales (source: ClinicalTrials.gov)
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2022
mars 2026
18 septembre 2025
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.
Etablissements
Critères
Tous
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)
- 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)
- 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