The BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial, published in The New England Journal of Medicine, reveals that a seven-day course of antibiotics is as effective as a 14-day course for treating bloodstream infections. This finding has the potential to significantly reduce hospital stays, decrease the spread of antibiotic resistance, and improve healthcare efficiency on a global scale.
The study, led by Sunnybrook Health Sciences Centre with Mount Sinai Hospital as a key site, involved 3,608 patients and was notable for its inclusion of participants from general inpatient units, an area often overlooked in randomized clinical trials.
Innovative Clinical Trial Framework
Historically, randomized clinical trials (RCTs) have often focused on specialized units, with general medicine in-patient units receiving less attention. During the COVID-19 pandemic, physicians at Sinai Health, led by Dr. Michael Fralick, developed a novel approach to include participants from the general inpatient population.
"We had to come up with a solution so that when the next patient with COVID-19 comes into our hospital, there will be clinical trials available to them and access to potential medications to treat their COVID-19," said Dr. Fralick.
This innovative model allowed Sinai Health to participate in global efforts to test COVID-19 treatments, leading to the discovery of life-saving therapies and informing patient care worldwide. The success of this approach paved the way for participation in non-COVID-19 trials like BALANCE.
Key Findings of the BALANCE Trial
The BALANCE trial demonstrated that a seven-day antibiotic course is non-inferior to a 14-day regimen in preventing deaths and infection relapses. Furthermore, the shorter antibiotic course reduces unnecessary antibiotic use and associated risks, such as gut infections and the development of antibiotic resistance.
"This is truly a landmark trial that will change practice in all areas of inpatient care—surgery, obstetrics, ICU and others," said Dr. Jennie Johnstone, an infections diseases physician.
The reduced duration of antibiotic treatment also leads to shorter hospital stays, providing substantial benefits for both patients and healthcare systems.
Training the Next Generation of Researchers
Sinai Health is committed to fostering future clinical leaders. Dr. Fralick has established a course to train medical and nursing students in the complexities of running clinical trials. These trainees played a crucial role in patient recruitment for the BALANCE trial, gaining valuable hands-on experience.
"Education is a cornerstone of our research mission," noted Dr. Johnstone. "By equipping the next generation of researchers with practical skills, we ensure the sustainability of these advancements."
Future Directions
The success of the BALANCE trial has paved the way for several ongoing international trials at Sinai Health that include the general inpatient population. These include BALANCE +, which aims to optimize treatment of bloodstream infections caused by gram-negative bacteria; A-DONUT, which is investigating the use of antibiotics in older adults with delirium; and SNAP, which is evaluating treatments for Staphylococcus aureus bloodstream infections.
"Our new framework allows us to answer important clinical questions that improve outcomes not just for our patients, but for patients worldwide," said Dr. Fralick.
