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Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled
Jennie Johnstone1, Diane Heels-Ansdell2, Lehana Thabane2
1Public Health Ontario, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.
Insights
This large clinical trial investigates if the probiotic Lactobacillus rhamnosus GG can prevent ventilator-associated pneumonia (VAP) in critically ill patients. Results will guide future VAP prevention strategies.
Area of Science:
- Critical Care Medicine
- Infectious Diseases
- Microbiology
Background:
- Ventilator-associated pneumonia (VAP) is a leading healthcare-associated infection in intensive care units (ICUs).
- Previous research suggests probiotics may reduce VAP, but trials have been limited in scope.
- The PROSPECT trial addresses the need for robust evidence on probiotic efficacy in VAP prevention.
Purpose of the Study:
- To evaluate the effectiveness of Lactobacillus rhamnosus GG in preventing VAP in mechanically ventilated adults.
- To assess the impact of this probiotic on other ICU-acquired infections and clinical outcomes.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial involving over 2600 critically ill patients.
- Participants received either Lactobacillus rhamnosus GG or a placebo twice daily.
- Primary outcome was the incidence of VAP; secondary outcomes included other infections, antimicrobial use, and mortality.
Main Results:
- Data collection and analysis are ongoing; this is a pre-results abstract.
- The study is powered to detect a 25% relative risk reduction in VAP.
- Results are anticipated to inform clinical practice guidelines globally.
Conclusions:
- The PROSPECT trial is a large-scale study designed to provide definitive evidence on probiotic use for VAP prevention.
- Findings will impact the management of critically ill patients and infection control strategies in ICUs worldwide.
Introduction:
Ventilator-associated pneumonia (VAP) is the most common healthcare-associated infection in critically ill patients. Prior studies suggest that probiotics may reduce VAP and other infections in critically ill patients; however, most previous randomised trials were small, single centre studies. The Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) aims to determine the impact of the probiotic Lactobacillus rhamnosus GG on VAP and other clinically important outcomes in critically ill adults.
Methods:
PROSPECT is a multicentre, concealed, randomised, stratified, blinded, controlled trial in patients ≥18 years old, anticipated to be mechanically ventilated ≥72 hours, in intensive care units (ICUs) in Canada, the USA and Saudi Arabia. Patients receive either 1×1010 colony forming units of L. rhamnosus GG twice daily or an identical appearing placebo. Those at increased risk of probiotic infection are excluded. The primary outcome is VAP. Secondary outcomes are other ICU-acquired infections including Clostridioides difficile infection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality. The planned sample size of 2650 patients is based on an estimated 15% VAP rate and will provide 80% power to detect a 25% relative risk reduction.
Ethics And Dissemination:
This protocol and statistical analysis plan outlines the methodology, primary and secondary analyses, sensitivity analyses and subgroup analyses. PROSPECT is approved by Health Canada (#9427-M1133-45C), the research ethics boards of all participating hospitals and Public Health Ontario. Results will be disseminated via academic channels (peer reviewed journal publications, professional healthcare fora including international conferences) and conventional and social media. The results of PROSPECT will inform practice guidelines worldwide.
Trialregistration Number:
NCT02462590; Pre-results.
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