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Principal Investigators
Dr. Nick Daneman
Dr. Rob Fowler

Thanks to all Participating Centers and collaborators for engaging in this research program!

Thanks to the CCCTG for endorsing this research project.

THE BALANCE RESEARCH PROGRAM

OVERALL GOAL OF THE BALANCE RESEARCH PROGRAM

The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE). Research Program seeks to define the optimal treatment duration for patients with bloodstream infection. The goal is to maximize the benefits while minimizing the harms of these treatments, including antibiotic resistance, C. difficile, and other drug-related side effects.


SYSTEMATIC REVIEW OF THE MEDICAL LITERATURE

We systematically reviewed the medical literature, and found no prior dedicated trials of shorter versus longer antibiotic treatment duration for non-newborn patients with bloodstream infection.  We did find two dozen prior studies of more than 7000 patients treated with shorter versus longer antibiotic courses for conditions commonly complicated by bloodstream infection (lung infection, urine infection, skin and soft tissue infection, intra-abdominal infection).   Very few of these studies reported on the outcomes of the subgroup of patients that had bloodstream infection.  In these small subgroups, shorter and longer duration treatment had similar cure rates.

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NATIONAL PRACTICE SURVEY OF CANADIAN INFECTIOUS DISEASES AND CRITICAL CARE PHYSICIANS

We conducted a national survey of Canadian Infectious Diseases and Critical Care Physicians, and learned that 14 days is the most commonly recommended treatment duration for patients with bloodstream infection, but that there are major variations in recommendations, and general agreement that a trial of 7 versus 14 days of treatment is needed.

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CROSS-CANADA MULTICENTRE OBSERVATIONAL STUDY

We studied actual treatment practices among more than 1200 patients with bloodstream infection across ICUs in 14 hospitals, in 10 Canadian cities and 6 Provinces.  This study confirmed that longer treatment durations are being used, irrespective of the bug or the source of the bloodstream infection.

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BALANCE PILOT RANDOMIZED CONTROLLED TRIAL

In a pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection we have confirmed the feasibility of this trial design.  Our recruitment rates and protocol adherence rates have exceeded expectations, and we are ready now to embark on the main trial.

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THE BALANCE MAIN RANDOMIZED CONTROLLED TRIAL

The BALANCE Main trial will randomize critically ill patients with bloodstream infection to 7 versus 14 days of antibiotics.  The trial will include 3598 patients, of which 2/3 will be enrolled in participating Canadian sites within the Canadian Critical Care Trials Group, and 1/3 will be enrolled in collaborating sites in United States (USCIIT GROUP), Australia, New Zealand (ANZICS), France, Germany and Saudi Arabia. The primary aim is 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 duration treatment (14 days).  The secondary aims are to determine whether shorter course treatment is associated with non-inferior secondary clinical outcomes (hospital mortality, ICU mortality, relapse rates of bacteremia, ICU length of stay, hospital length of stay, mechanical ventilation duration, vasopressor duration) while leading to improvements in antibiotic-free days in ICU, C. difficile infection, antibiotic allergy and adverse events, and colonization/infection with antibiotic-resistant organisms.


Program Figure