Antibiotic Duration for Severe Lung Infections

(BALANCE Trial)

Recruiting at75 trial locations

Overseen by Nick Daneman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?

The World Health Organization, U.S. Centers for Disease Control and Prevention, Association of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all declared antimicrobial resistance a global threat to health, based on rapidly increasing resistance rates and declining new drug development. Up to 30-50% of antibiotic use is inappropriate, and excessive durations of treatment are the greatest contributor to inappropriate use. Shorter duration treatment (≤7 days) has been shown in meta-analyses to be as effective as longer antibiotic treatment for a range of mild to moderate infections. A landmark trial in critically ill patients with ventilator-associated pneumonia showed that mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of treatment. Similar adequately powered randomized trial evidence is lacking for the treatment of patients with bloodstream infections caused by a wide spectrum of organisms.

Research Team

Nick Daneman, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for critically ill patients in the ICU or other hospital wards with a bacterial blood infection confirmed by a positive blood culture. It's not for those with certain heart valve conditions, specific types of bacteria or fungi in their blood, previous enrollment, severe immune compromise, infections requiring long treatments, or rare pathogens.

Inclusion Criteria

Patient has a positive blood culture with pathogenic bacteria.

Patient is in ICU or non-ICU ward at the time the blood culture is drawn or reported as positive.

Exclusion Criteria

You have an artificial heart valve or a synthetic graft used to repair a major blood vessel.

Patient has a single positive blood culture with a common contaminant organism according to Clinical Laboratory & Standards Institute (CLSI) Guidelines: coagulase negative staphylococci; or Bacillus spp.; or Corynebacterium spp.; or Propionobacterium spp.; or Aerococcus spp.; or Micrococcus spp.

Patient has a positive blood culture with Staphylococcus aureus or Staphylococcus lugdunensis

Treatment Details

Interventions

• Adequate Antibiotic Treatment (Antibiotic)

Trial Overview The study tests if 7 days of antibiotics are as effective as the standard 14 days for treating bloodstream infections in critically ill patients. The goal is to see if shorter treatment can work and help combat antibiotic resistance without compromising patient health.

Participant Groups

Group I: Short duration (7 days) Active Control 1 Intervention

Patients in 7 day arm will receive adequate antibiotics until the end of day 7 only

Group II: Long duration (14 days) Active Control 1 Intervention

Patients in 14 day arm will receive adequate antibiotics until the end of day 14 only

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Dr. Rajin Mehta

Sunnybrook Health Sciences Centre

Chief Medical Officer

MD from University of Toronto

Dr. Andrew J. Smith

Sunnybrook Health Sciences Centre

President and CEO since 2017

MD, MSc from University of Toronto; Surgical Oncology Fellowship at Memorial Sloan-Kettering Cancer Center