Nick Daneman & Rob Fowler" class="rev-slidebg" data-no-retina> INNOVATION FUND Innovation, Integration, & Implementation Patient Safety and Quality of Care SHOWCASE 2016 Nick Daneman & Rob Fowler" class="rev-slidebg" data-no-retina> INNOVATION FUND Innovation, Integration, & Implementation Patient Safety and Quality of Care SHOWCASE 2016

Sunnybrook Hospital Wide Stewardship for Broad spectrum Antimicrobials - Optimizing Duration of Treatment for Bloodstream Infections

Patient Safety and Quality of Care

Presenter: Asgar Rishu

asgar.rishu@sunnybrook.ca

416-480-6100 x88153

Sunnybrook Health Sciences Centre, Sunnybrook Research Institute

nick_daneman

Nick Daneman

nick.daneman@sunnybrook.ca

416-480-6100 x 2791

Sunnybrook Health Sciences Centre, Sunnybrook Research Institute

rob_fowler

Rob Fowler

Sunnybrook Health Sciences Centre, Sunnybrook Research Institute

Highlights

The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) research program has been made possible by two instrumental  AHSC AFP Innovation Fund awards (2010/2011  and 2013/2014) .  Through the first award we completed an observational study on duration of treatment in 1,202 critically ill bacteremic patients  across 14 ICUs in 10 cities and 6 Provinces.  This study demonstrated typically prolonged treatment durations (median 14 days), wide practice variation (interquartile range 9-17.5d) , and equipoise for a trial of shorter versus longer treatment.  (Critical Care Medicine  2016).  Through the second award we performed a pilot randomized controlled trial, to test the feasibility of randomizing critically ill patients with bacteremia to 7 versus 14 days of treatment.   This pilot study recently reached its target enrolment of 115 patients, and has confirmed the feasibility of a trial with respect to recruitment rates and protocol adherence.  We leveraged the results of these studies towards a Canadian Institutes of Health Research Project Scheme application in March 2016, and have recently received funding  ($2,010,635 over 5 years)   to perform the main trial (n=3600 patients).  The trial will be conducted in a minimum of 38 ICUs in Canada, Australia, New Zealand, Switzerland, Saudi Arabi, and possibly France and USA.

Abstract

Rationale: The optimal duration of antimicrobial treatment for bloodstream infections is undetermined, and in the absence of evidence, prolonged durations are contributing to antimicrobial resistance, C. difficile infection, adverse events and high healthcare costs.

Goal:To determine the optimal duration of treatment for bloodstream infections to maximize clinical outcomes while minimizing the harms of antimicrobial treatment.

Primary Aim/Objective: To determine whether shorter duration antibiotic treatment (7 days) for critically ill patients with bloodstream infection is associated with non-inferior survival rates (at 90 days) to those achieved with longer treatment (14 days).

Secondary Aims/Objectives: To determine whether shorter course treatment is associated with non-inferior secondary clinical outcomes (hospital and ICU mortality, relapse rates of bacteremia, ICU and hospital length of stay, mechanical ventilation duration, vasopressor duration) while leading to more antibiotic-free days in ICU, and fewer C. difficile infections, adverse events, and colonization/infection with antibiotic-resistant organisms.

Design: multicentre, randomized, non-inferiority, concealed allocation trial

Sample size: 3598 patients over 5 years.

Outputs: BALANCE trial represents the culmination of the BALANCE research program, which has included successful completion of a systematic review of the literature, national survey of infectious diseases and critical care physicians, single centre retrospective study, multicentre observational study, and pilot RCT.  The BALANCE main trial will establish the treatment paradigm for this common and serious infection, translating to rapid improvements in the care of critically ill patients globally, and potential cost-savings for the Canadian healthcare system.

Themes & Abstracts

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