Respiratory Trials·org

Sepsis & septic shock · Duration of antibiotic therapy

BALANCE randomised trial

Antibiotic Treatment for 7 versus 14 Days in Patients with Bloodstream Infections

BALANCE trial design and results
Design Multicentre, non-inferiority randomised controlled trial across 74 hospitals in seven countries
Treatment 7 days of antibiotic treatment
Control 14 days of antibiotic treatment
Population 3608 hospitalised patients with bloodstream infection
Follow-up 90 days
Primary endpoint 90-day all-cause mortality, tested for non-inferiority
Result 1814 patients were assigned to 7 days and 1794 to 14 days. Seven days was non-inferior to 14 days for 90-day mortality.
Secondary endpoints Relapse of bacteraemia, Clostridioides difficile infection, antimicrobial resistance, ICU and hospital stay

Among hospitalized patients with bloodstream infection, antibiotic treatment for 7 days was noninferior to treatment for 14 days.

The trial authors, in the published abstract

How it has aged

Extends the short-course principle of PneumA to bacteraemia, in one of the largest antibiotic duration trials ever run. Halving treatment in this population removes an enormous amount of antibiotic exposure with no measurable cost.

Publications

Antibiotic Treatment for 7 versus 14 Days in Patients with Bloodstream Infections

Daneman N, Rishu A, Pinto R, et al. Antibiotic Treatment for 7 versus 14 Days in Patients with Bloodstream Infections. N Engl J Med 2025 Mar 13;392(11):1065-1078.

  • 7 days non-inferior to 14 days for 90-day mortality
  • 3608 patients across 74 hospitals in seven countries