This study outlines the protocol and statistical analysis plan for a preplanned secondary analysis of the PROSPECT trial (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial).

The goal of this research is to investigate the association between patient frailty and the risk of developing ICU-acquired infections, specifically Ventilator-Associated Pneumonia (VAP) and other healthcare-associated infections, in invasively ventilated patients across 44 ICUs.

The analysis will utilize Cox proportional hazards regression to determine the relationship, adjusting for other baseline variables, with results presented as adjusted Hazard Ratios (HRs) or Odds Ratios (ORs) with 95% Confidence Intervals (CIs).

By leveraging the data and ethical approvals from the original PROSPECT trial, this study aims to clarify whether pre-existing frailty significantly increases a critically ill patient’s vulnerability to these infections.

The findings are expected to be highly relevant for clinicians, patients, and caregivers, potentially influencing future clinical practice and research design in critical care.

The dissemination plan is comprehensive, including traditional and social media (such as the creation of visual abstracts and infographics) to ensure the study results reach both clinician-facing and public-facing platforms following presentation at international conferences and peer-reviewed publication.

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