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1. Academic and Community ICUs Participating in a Critical Care Randomized Trial: A Comparison of Patient Characteristics and Trial Metrics

Author

Jennifer L. Y. Tsang, MD, PhD, Alexandra Binnie, MD, DPhil, Erick H. Duan, MD, MSc, Jennie Johnstone, MD, PhD, Diane Heels-Ansdell, MSc, Brenda Reeve, MD, Sebastien Trop, MD, PhD, Paul Hosek, MD, Joanna C. Dionne, MD, PhD, Patrick Archambault, MD, MSc, Paul Lysecki, MD, Robert Cirone, MD, Nicole L. Zytaruk, RN, William Dechert, MSc, Mercedes Peñuela Camargo, MSc, Rebecca Jesso, MN, NP, Elliot McMillan, RN, PhD, Zaynab Panchbhaya, MSN, Tracy Campbell, MSc, Lois Saunders, Mary Copland, BA, Kanthi Kavikondala, BSc, Deborah J. Cook, MD, MSc, and for the Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) Investigators and the Canadian Critical Care Trials Group

Subjects
Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

OBJECTIVES:. Clinical research in Canada is conducted primarily in “academic” hospitals, whereas most clinical care is provided in “community” hospitals. The objective of this nested observational study was to compare patient characteristics, outcomes, process-of-care variables, and trial metrics for patients enrolled in a large randomized controlled trial who were admitted to academic and community hospitals in Canada. DESIGN:. We conducted a preplanned observational study nested within the Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT, a randomized controlled trial comparing probiotics to placebo in mechanically ventilated patients) Research Program. SETTING:. ICUs. PATIENTS:. Mechanically ventilated patients. MEASUREMENTS:. We compared patient characteristics, interventions, outcomes, and trial metrics between patients enrolled in PROSPECT from academic and community hospitals. MAIN RESULTS:. Participating centers included 34 (82.9%) academic and seven (17.1%) community hospitals, which enrolled 2,203 (86.2%) and 352 (13.8%) patients, respectively. Compared with academic hospitals, patients enrolled in community hospitals were older (mean [sd] 62.7 yr [14.9 yr] vs 59.5 yr [16.4 yr]; p = 0.044), had longer ICU stays (median [interquartile range {IQR}], 13 d [8–23 d] vs 11 d [7–8 d]; p = 0.012) and higher mortality (percentage, [95% CI] in the ICU, 30.4% [25.8–35.4%]vs 20.5% [18.9–11.3%]; p = 0.002) and hospital (40.6% [35.6–45.8%] vs 26.1% [24.3–27.9%]; p < 0.001). Trial metrics, including informed consent rate (85.9% vs 76.3%; p = 0.149), mean (sd) monthly enrolment rate (2.1 [1.4] vs 1.1 [0.7]; p = 0.119), and protocol adherence (90.6% vs 91.6%; p = 0.207), were similar between community and academic ICUs. CONCLUSIONS:. Community hospitals can conduct high-quality research, with similar trial metrics to academic hospitals. Patient characteristics differed between community and academic hospitals, highlighting the need for broader engagement of community hospitals in clinical research to ensure generalizability of study results.

Published
2022
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2. A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

Author

Nick Daneman, Asgar H. Rishu, Ruxandra Pinto, Yaseen Arabi, Emilie P. Belley-Cote, Robert Cirone, Mark Downing, Deborah J. Cook, Richard Hall, Shay McGuinness, Lauralyn McIntyre, John Muscedere, Rachael Parke, Steven Reynolds, Benjamin A. Rogers, Yahya Shehabi, Phillip Shin, Richard Whitlock, Robert A. Fowler, and on behalf of the Canadian Critical Care Trials Group

Subjects
Bacteremia, Bloodstream infection, Critical care, Intensive care, Duration of treatment, Medicine (General), R5-920
Abstract

Abstract Background The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards. Methods We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and non-inferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients. Results A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1–4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/site-month, p

Published
2020
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3. Effect of Probiotics on Incident Ventilator-Associated Pneumonia in Critically Ill Patients: A Randomized Clinical Trial

Author

Peter Dodek, Lehana Thabane, Arnold S. Kristof, Michael G. Surette, Joanna C. Dionne, Francois Lamontagne, Ryan Zarychanski, James Kutsogiannis, Lauralyn McIntyre, David Williamson, Daniel Ovakim, Diane Heels-Ansdell, François Lauzier, Daphnée Lamarche, Dave Nagpal, Deborah J. Cook, Henry T. Stelfox, Neill K. J. Adhikari, Daniel J. Niven, Robert Cirone, Frédérick D’Aragon, Sangeeta Mehta, Rodrigo Cartin-Ceba, Erick Duan, François Marquis, Charles St-Arnaud, Alberto Goffi, Paul Hosek, Eyal Golan, Osama Loubani, Kosar Khwaja, William R. Henderson, Jan O. Friedrich, Maureen O. Meade, John Granton, Jennifer L Y Tsang, Robert W. Taylor, Paul J Lysecki, John Muscedere, Yaseen M. Arabi, Endotracheal Colonization Trial (Prospect) Investigators, Tim Karachi, Richard I. Hall, M. Elizabeth Wilcox, Nicole Zytaruk, John Marshall, François Lellouche, Alexandra Binnie, Jennie Johnstone, Patrick Archambault, Martin Girard, Margaret S. Herridge, Wendy I. Sligl, Bram Rochwerg, Gordon Wood, Ian M Ball, Shane W. English, Emmanuel Charbonney, Sébastien Trop, Steve Reynolds, Brenda Reeve, Bojan Paunovic, and Pierre Aslanian

Subjects
Diarrhea, Male, medicine.medical_specialty, Population, Placebo, law.invention, Randomized controlled trial, Lactobacillus rhamnosus, law, Internal medicine, medicine, Humans, Treatment Failure, education, Adverse effect, Aged, Original Investigation, education.field_of_study, biology, business.industry, Lacticaseibacillus rhamnosus, Probiotics, Hazard ratio, Ventilator-associated pneumonia, Pneumonia, Ventilator-Associated, General Medicine, Bacterial Infections, Middle Aged, medicine.disease, biology.organism_classification, Intensive care unit, Respiration, Artificial, Anti-Bacterial Agents, Intensive Care Units, Female, business
Abstract

IMPORTANCE: Growing interest in microbial dysbiosis during critical illness has raised questions about the therapeutic potential of microbiome modification with probiotics. Prior randomized trials in this population suggest that probiotics reduce infection, particularly ventilator-associated pneumonia (VAP), although probiotic-associated infections have also been reported. 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 × 10(10) colony-forming units) (n = 1321) or placebo (n = 1332) twice daily in the ICU. MAIN OUTCOMES AND MEASURES: The primary outcome was VAP determined by duplicate blinded central adjudication. Secondary outcomes were other ICU-acquired infections including Clostridioides difficile infection, diarrhea, antimicrobial use, ICU and hospital length of stay, and mortality. 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

Published
2021

4. A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

Author

Robert Cirone, Ruxandra Pinto, Shay McGuinness, Richard P. Whitlock, Richard I. Hall, Deborah J. Cook, Rachael Parke, John Muscedere, Asgar H. Rishu, Nick Daneman, Steven Reynolds, Yahya Shehabi, Lauralyn McIntyre, Robert A. Fowler, Phillip Shin, Yaseen M. Arabi, Benjamin A. Rogers, Mark Downing, and Emilie P. Belley-Côté

Subjects
Male, medicine.medical_specialty, Time Factors, medicine.drug_class, Antibiotics, Medicine (miscellaneous), Bacteremia, Comorbidity, Bloodstream infection, law.invention, 03 medical and health sciences, 0302 clinical medicine, Clinical Protocols, Randomized controlled trial, law, Intensive care, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Mortality, Aged, Aged, 80 and over, 0303 health sciences, lcsh:R5-920, 030306 microbiology, business.industry, Research, Mortality rate, Middle Aged, medicine.disease, Intensive care unit, Anti-Bacterial Agents, 3. Good health, Intensive Care Units, Critical care, Treatment Outcome, Sample size determination, Case-Control Studies, Feasibility Studies, Female, business, Duration of treatment, lcsh:Medicine (General)
Abstract

Background The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards. Methods We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and non-inferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients. Results A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1–4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/site-month, p p = 0.0003). BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection. The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%), which was comparable to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%) (p = 0.65). Simulation models indicated there would be minimal sample size and non-inferiority margin implications of expanding enrolment to increasing proportions of non-ICU versus ICU patients. Conclusion It is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results. Trial registration Clinicaltrials.gov, NCT02917551. Registered on September 28, 2016.

Published
2020

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