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Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care (the ASPIC trial): study protocol for
Arnaud Foucrier1, Antoine Roquilly2, Delphine Bachelet3
1Department of Anaesthesiology and Critical Care, Beaujon Hospital, DMU Parabol, AP-HP Nord, Université de Paris, Hospital Beaujon, Clichy, France arnaud.foucrier@aphp.fr.
Introduction:
Ventilator-associated pneumonia (VAP) remains the leading cause of infections treated in the intensive care units (ICU). In a personalised care approach, we hypothesise that the duration of treatment of VAP can be reduced in function of the response to treatment.
Methods And Analysis:
The Antimicrobial Stewardship for Ventilator-Associated Pneumonia in Intensive Care (ASPIC) trial is a pragmatic national multicentre, phase III, non-inferiority, comparative randomised (1:1) single-blinded clinical trial. Five hundred and ninety adult patients hospitalised in 24 French ICU with a microbiologically confirmed first episode of VAP that received appropriate empirical antibiotic therapy will be included. They will be randomly allocated to standard management with duration of appropriate antibiotic fixed for 7 days according to international guidelines or antimicrobial stewardship based on daily clinical assessment of clinical cure. The assessment of clinical cure will be repeated daily until at least three criteria of clinical cure are met, allowing the discontinuation of antibiotic therapy in experimental group. The primary endpoint is a composite endpoint combining of all-cause mortality measured at day 28, treatment failure or new episode of microbiologically confirmed VAP until day 28.The aim of the study is to demonstrate that a strategy to reduce the duration of antibiotic therapy for VAP based on clinical assessment is safe could lead to changes in practice as part of a personalised therapeutic approach, by reducing exposure to antibiotics and their side effects.
Ethics And Dissemination:
The ASPIC trial has been approved by the French regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM; EUDRACT number 2021-002197-78, 19 August 2021) and an independent ethics committee the Comité de Protection des Personnes Ile-de-France III (CNRIPH : 21.03.25.60729, 10 October 2021) for the study protocol (version ASPIC-1.3; 03 September 2021) for all study centres. Participant recruitment is scheduled to begin in 2022. Results will be published in international peer-reviewed medical journals.
Trial Registration Number:
NCT05124977.
Insights
This study investigates reducing antibiotic duration for ventilator-associated pneumonia (VAP) based on patient response. The goal is to demonstrate safety and efficacy of personalized treatment in intensive care units (ICUs).
Area of Science:
- Critical Care Medicine
- Infectious Diseases
- Clinical Pharmacology
Background:
- Ventilator-associated pneumonia (VAP) is a leading ICU infection.
- Current treatment guidelines recommend a fixed 7-day antibiotic course.
- Personalized care approaches may optimize VAP treatment duration.
Purpose of the Study:
- To evaluate if reducing antibiotic duration for VAP based on clinical cure assessment is non-inferior to standard 7-day treatment.
- To demonstrate the safety and potential practice changes of a personalized, response-based VAP therapy.
- To reduce antibiotic exposure and associated side effects in ICU patients.
Main Methods:
- The Antimicrobial Stewardship for Ventilator-Associated Pneumonia in Intensive Care (ASPIC) trial is a phase III, randomized, controlled trial.
- 590 adult patients with confirmed VAP in 24 French ICUs will be included.
- Patients will be randomized to standard 7-day antibiotics or a stewardship approach with daily clinical assessment for early discontinuation.
Main Results:
- Primary endpoint: composite of 28-day all-cause mortality, treatment failure, or new VAP episode.
- Secondary endpoints will assess the impact on antibiotic exposure and patient outcomes.
- The study aims to demonstrate non-inferiority of the stewardship approach.
Conclusions:
- The ASPIC trial will provide evidence on a personalized, clinical assessment-driven strategy for VAP treatment.
- Findings could lead to reduced antibiotic use and improved patient safety in ICUs.
- Successful implementation may shift clinical practice towards tailored VAP management.
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