Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): A Randomized Controlled Clinical Trial

Bloodstream infections are a common and serious problem, affecting 15% of critically ill patients, increasing length of hospital stay by 2-3 weeks, adding $25,000-40,000 in excess hospital costs, and tripling the risk of death. At the same time, antibiotic overuse is also a common and serious problem, in that 30-50% of antibiotic use is unnecessary or inappropriate, and results in avoidable drug side effects such as kidney failure, Clostridium difficile infection, increased costs, and spiraling antibiotic resistance rates. The greatest contributor to antibiotic overuse is excessive treatment duration. Shorter duration antibiotic treatment (= 7 days) is as effective as longer duration treatment for ear infections, bladder infections, and pneumonia, but this question has not been directly studied in the setting of bloodstream infection. Our team's systematic review of the medical literature, national survey of Canadian infectious diseases and critical care physicians, and multicentre retrospective study (N=1202) all support the need for a randomized controlled trial comparing shorter (7 days) versus longer (14 days) antibiotic treatment for bloodstream infections. Our CIHR-funded multicenter BALANCE Pilot trial, has established the feasibility of this trial design, with excellent recruitment rates, and adherence to treatment duration protocols. In this proposal for the main BALANCE trial, we will definitively determine whether 7 days of treatment is associated with non-inferior survival rates as compared to 14 days of treatment. By defining the duration of treatment for bloodstream infections, our research program will help maximize the clinical cure of individual patients, while minimizing their risk of drug side effects, C. difficile, and antibiotic resistance. Since this intervention would require no new technology, and would reduce (rather than increase) health care costs, it would offer immediate benefits to patients and the healthcare system.