Probiotics: PRevention Of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Pilot Trial
This pilot project assessed the feasibility of a large future study in mechanically ventilated intensive care unit (ICU) patients in six ICUs in Ontario, Québec, British Columbia, Minnesota and Missouri. This preliminary pilot trial approach has increased the efficiency and cost effectiveness of many subsequent large-scale studies in the critical care community.
Findings: (1) 150 patients were enrolled over 11 months and recruitment was 1.9 patients per month; (2) adherence of study product was 97%, (3) contamination did not occur; no patients received open-label probiotics, and (4) the adjudicated VAP rate was 19%. The PROSPECT Pilot Trial met all four feasibility objectives of timely recruitment, high adherence to protocol, minimal contamination and VAP burden to target. It also helped to refine pharmacy randomization, product preparation, consent documents and case report forms, as well as estimate realistic timelines for completion. The successful Pilot Trial completion led to the PROSPECT Vanguard Phase of 300 patients as of November 2015.
Impact of findings: A definitive trial showing that probiotics are beneficial against VAP will have an expedited translation into practice by nutritionists, pharmacists, nurses, physicians and managers, given the high baseline risk of VAP among elderly critically ill patients. If probiotics help to decrease potentially lethal infections (VAP), we will have fostered globally recognized research to improve the outcomes of frail elderly patients. If probiotics do indeed lower the risk of VAP, clinical benefits will be lower VAP rates and healthcare expenditures due to this potentially lethal clinical problem.
Publications, presentations and webinars
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About the Project
Several studies have suggested multiple benefits to critically ill patients who receive probiotics in the ICU. Probiotics appear to mitigate infections, which can lead to costly long stays in the ICU and even fatalities. However, whether probiotics are truly helpful is unclear because of the typically small sample sizes and variable study quality to date.
Before a large expensive international study is done to evaluate the true effects of probiotics in critically ill patients, a pilot trial is needed.
The PROSPECT Pilot Trial proved highly instructive to the ongoing search for more effective strategies to prevent serious infection during critical illness. Probiotics may be a simple, easy-to-use, readily available, inexpensive approach to help reduce infection rates in critically ill elderly patients worldwide.
For more details on the project rationale, objectives and research plan, click here.
Deborah Cook, MD, MSc (Epid), FRCPC, DABIM, CCM, CAHS, FRS -- McMaster University
Dawn M.E. Bowdish, PhD -- McMaster University/Canadian Critical Care Trials Group
Peter Dodek, MD -- University of British Columbia/Canadian Critical Care Trials Group
Erick Duan, MD -- McMaster University/Canadian Critical Care Trials Group
Eyal Golan, MD -- University of Toronto/Canadian Critical Care Trials Group
William Henderson, MD -- University of British Columbia/Canadian Critical Care Trials Group
Margaret Herridge, MD -- University of Toronto/Canadian Critical Care Trials Group
Daren Heyland, MD, MSc, FRCPC -- Queen's University
Jenny Johnstone, MD, FRCPC -- McMaster University
Tim Karachi, MD -- McMaster University/Canadian Critical Care Trials Group
Daphnee Lamarche -- McMaster University
François Lauzier, MD, MSc -- Université Laval
John Marshall, MD, MSc, FRCPC, AGAF -- McMaster University
Lauralyn McIntyre, MD -- University of Ottawa/Canadian Critical Care Trials Group
Maureen Meade, BSc, MSc, MD -- McMaster University
Sangeeta Mehta, MD -- University of Toronto/Canadian Critical Care Trials Group
Daniel Ovakim, MD -- University of Victoria/Canadian Critical Care Trials Group
Joe Pagliarello, MD -- University of Ottawa/Canadian Critical Care Trials Group
Michael G. Surette, PhD -- McMaster University/Canadian Critical Care Trials Group
Lehana Thabane, PhD -- McMaster University/Canadian Critical Care Trials Group
Paul Wischmeyer, MD, BSc -- University of Colorado Hospital
Gordon Wood, MD -- University of Victoria/Canadian Critical Care Trials Group
Project Contact: Dr. Deborah Cook -- firstname.lastname@example.org
Key words: probiotics; pneumonia; prevention; critical care; nosocomial infection; lactobacillus; lung infection