Reducing antibiotic use for pneumonia in ICU patients on ventilators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.