PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial) A Pilot Study
CCCF ePoster library. Cook D. Oct 26, 2015; 117325; P27 Disclosure(s): Physicians Services Incorporated of Ontario, Technology Evaluation in the ElderlyNetwork, and the Canadian Institutes for Health Research.
Deborah Cook
Deborah Cook
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Abstract
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P27


Topic: Clinical Trial


PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial) A Pilot Study



Deborah Cook, J. Johnstone, M. John, F. Lauzier, L. Thabane, S. Mehta, P. Dodek, L. McIntyre, G. Pagliarello, W. Henderson, R. Taylor, R. Cartin-Ceba, E. Golan, M. Herridge, G. Wood, D. Ovakim, T. Karachi, M. Surette, D. Bowdish, D. Lamarche, C. Verschoor, E. Duan, D. Heels-Ansdell, M. Meade

Departments of Medicine and Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada | Medicine, Public Health Ontario, Toronto, Canada | Department of Surgery, St Michael's Hospital, Toronto, Canada | Department of Anesthesiology & Critical Care, Université Laval, Quebec, Canada | Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada | Departments of Medicine and Critical Care, University of Toronto, Toronto, Canada | Division of Critical Care Medicine and Center for Health Evaluation and Outcome Sciences, St. Paul’s Hospital and University of British Columbia, Vancouver, Canada | Department of Critical Care, University of Ottawa, Ottawa, Canada | Department of Critical Care, University of Ottawa, Ottawa, Canada | Division of Critical Care, Vancouver General Hospital, Vancouver, Canada | Departments of Pulmonary and Critical Care Medicine, St John’s Mercy Hospital, St. Louis, United States of America | Division of Pulmonary and Critical Carer Medicine, Mayo Clinic, Rochester, United States of America | Critical Care, University of Toronto, Toronto, Canada | Critical

Introduction: Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials in critically ill patients suggest that probiotics decrease the incidence of ventilator-associated pneumonia (VAP) by 25% and the overall incidence of infection by 18%. However, these trials were small, mostly single-center, and at risk of bias.

Objectives: The aim of the PROSPECT Pilot Trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU).

Methods: We randomized patients who were expected to be mechanically ventilated for ≥72 hours to receive either 1x1010 colony forming units (CFU) of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo, twice daily via gastric or duodenal tube. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had strict contraindications to enteral medication. Patients, families, and clinical and research staff were blinded. Feasibility objectives were: 1) Recruitment of at least 150 patients over 1 year; 2) Successful protocol adherence (administration of ≥ 90% of prescribed doses); 3) Minimal contamination (<5% of patients receive an open-label probiotic); and 4) An overall VAP rate of >10%. Clinical outcomes, which will be the focus of the main trial, were all respiratory and other infections, diarrhea (total, antibiotic-associated and Clostridium difficile), ICU and hospital length of stay and mortality.

Results: We randomized 150 patients from 14 centers in Canada and the US (informed consent rate of 83.3%). All feasibility goals were met: 1) Recruitment was achieved in 1 year; 2) protocol adherence was 97.4%; 3) No patients received open label probiotics; 4) The VAP rates ranged from 10-40% depending on the definition.

Conclusion:

The PROSPECT Pilot Trial supports the feasibility of a larger trial to investigate the effect of enteral L. rhamnosus GG on VAP and other nosocomial infections in mechanically ventilated critically ill patients.



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