Reducing antibiotic use for pneumonia in ICU patients on ventilators
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
This study tests if shorter courses of antibiotics can effectively treat pneumonia in ICU patients on ventilators while helping to prevent antibiotic resistance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Clichy-sous-Bois) |
| Trial ID | NCT05124977 on ClinicalTrials.gov |
What this trial studies
This study focuses on implementing antimicrobial stewardship to manage ventilator-associated pneumonia (VAP) in intensive care unit (ICU) patients. It aims to evaluate the effectiveness of short-course antibiotic therapy compared to longer durations, addressing the urgent issue of multidrug-resistant bacteria. The study will include patients diagnosed with microbiologically confirmed VAP who have received appropriate initial antibiotic therapy. By optimizing antibiotic use, the study seeks to reduce the emergence of antibiotic resistance while ensuring effective treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are ICU patients diagnosed with their first episode of microbiologically confirmed ventilator-associated pneumonia.
Not a fit: Patients who do not have microbiologically confirmed VAP or those who have already received prolonged antibiotic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective management of pneumonia in ICU patients while minimizing the risk of antibiotic resistance.
How similar studies have performed: Previous studies have shown that antimicrobial stewardship initiatives can be effective in managing community-acquired pneumonia, suggesting potential for success in this context as well.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clichy-sous-Bois
- Foucrier — Clichy-sous-Bois, France (Recruiting)
Study contacts
- Principal investigator: Arnaud Foucrier — Aphp
- Study coordinator: Arnaud Foucrier
- Email: arnaud.foucrier@aphp.fr
- Phone: +33 1 40 87 52 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.