Abstract | Importance: Objective: To evaluate the effect of Lactobacillus rhamnosus GG on preventing VAP, additional infections, and other clinically important outcomes in the intensive care unit (ICU). Design, Setting, and Participants: Randomized placebo-controlled trial in 44 ICUs in Canada, the United States, and Saudi Arabia enrolling adults predicted to require mechanical ventilation for at least 72 hours. A total of 2653 patients were enrolled from October 2013 to March 2019 (final follow-up, October 2020). Interventions: Enteral L rhamnosus GG (1 × 1010 colony-forming units) (n = 1321) or placebo (n = 1332) twice daily in the ICU. Main Outcomes and Measures: Results: Among 2653 randomized patients (mean age, 59.8 years [SD], 16.5 years), 2650 (99.9%) completed the trial (mean age, 59.8 years [SD], 16.5 years; 1063 women [40.1%.] with a mean Acute Physiology and Chronic Health Evaluation II score of 22.0 (SD, 7.8) and received the study product for a median of 9 days (IQR, 5-15 days). VAP developed among 289 of 1318 patients (21.9%) receiving probiotics vs 284 of 1332 controls (21.3%; hazard ratio [HR], 1.03 (95% CI, 0.87-1.22; P = .73, absolute difference, 0.6%, 95% CI, -2.5% to 3.7%). None of the 20 prespecified secondary outcomes, including other ICU-acquired infections, diarrhea, antimicrobial use, mortality, or length of stay showed a significant difference. Fifteen patients (1.1%) receiving probiotics vs 1 (0.1%) in the control group experienced the adverse event of L rhamnosus in a sterile site or the sole or predominant organism in a nonsterile site (odds ratio, 14.02; 95% CI, 1.79-109.58; P < .001). Conclusions and Relevance: Trial Registration: ClinicalTrials.gov Identifier: NCT02462590.
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Authors | Jennie Johnstone, Maureen Meade, François Lauzier, John Marshall, Erick Duan, Joanna Dionne, Yaseen M Arabi, Diane Heels-Ansdell, Lehana Thabane, Daphnee Lamarche, Michael Surette, Nicole Zytaruk, Sangeeta Mehta, Peter Dodek, Lauralyn McIntyre, Shane English, Bram Rochwerg, Tim Karachi, William Henderson, Gordon Wood, Daniel Ovakim, Margaret Herridge, John Granton, M Elizabeth Wilcox, Alberto Goffi, Henry T Stelfox, Daniel Niven, John Muscedere, François Lamontagne, Frédérick D'Aragon, Charles St-Arnaud, Ian Ball, Dave Nagpal, Martin Girard, Pierre Aslanian, Emmanuel Charbonney, David Williamson, Wendy Sligl, Jan Friedrich, Neill K Adhikari, François Marquis, Patrick Archambault, Kosar Khwaja, Arnold Kristof, James Kutsogiannis, Ryan Zarychanski, Bojan Paunovic, Brenda Reeve, François Lellouche, Paul Hosek, Jennifer Tsang, Alexandra Binnie, Sébastien Trop, Osama Loubani, Richard Hall, Robert Cirone, Steve Reynolds, Paul Lysecki, Eyal Golan, Rodrigo Cartin-Ceba, Robert Taylor, Deborah Cook, Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) Investigators and the Canadian Critical Care Trials Group |
Journal | JAMA
(JAMA)
Vol. 326
Issue 11
Pg. 1024-1033
(09 21 2021)
ISSN: 1538-3598 [Electronic] United States |
PMID | 34546300
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Aged
- Anti-Bacterial Agents
(adverse effects, therapeutic use)
- Bacterial Infections
(prevention & control)
- Diarrhea
(prevention & control)
- Female
- Humans
- Intensive Care Units
- Lacticaseibacillus rhamnosus
- Male
- Middle Aged
- Pneumonia, Ventilator-Associated
(prevention & control)
- Probiotics
(therapeutic use)
- Respiration, Artificial
(adverse effects)
- Treatment Failure
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