Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating ventilator-associated pneumonia (VAP) in patients who are receiving mechanical ventilation in intensive care units (ICUs). The goal is to see if a method called "antimicrobial stewardship," which involves daily evaluations to determine if antibiotics can be stopped sooner, is just as safe and effective as the standard longer antibiotic treatment. This is important because overusing antibiotics can lead to drug-resistant bacteria, which is a growing concern in healthcare.

To be eligible for the trial, participants must have a confirmed first episode of VAP and have started appropriate antibiotic treatment. They should also be at least 65 years old and able to give consent, or have a legal representative to do so. If you join the study, you will be randomly assigned to either the new approach with daily assessments or the standard treatment. Throughout the trial, your health will be monitored closely, and the researchers will check to ensure that the new treatment does not lead to more complications or deaths compared to the usual care. This trial is currently recruiting participants across 31 centers, and all genders are welcome to join.

Gender

ALL

Eligibility criteria

• 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