BALANCE
Trial question
Is antibiotic treatment for 7 days noninferior to treatment for 14 days in hospitalized patients with bloodstream infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 3608
3608 patients (1686 female, 1922 male).
Inclusion criteria: hospitalized patients with bloodstream infection.
Key exclusion criteria: severe immunocompromised state; prosthetic heart valves or endovascular grafts; infectious syndrome that required prolonged treatment; positive culture with a common contaminant; S. aureus or S. lugdunensis bacteremia; bacteremia from rare organisms that required prolonged treatment; fungemia.
Interventions
N=1814 7-day antibiotic therapy (adequate antibiotic treatment for 7 days).
N=1794 14-day antibiotic therapy (adequate antibiotic treatment for 14 days).
Primary outcome
Rate of death from any cause by 90 days after diagnosis
14.5%
16.1%
16.1 %
12.1 %
8.1 %
4.0 %
0.0 %
7-day antibiotic
therapy
14-day antibiotic
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of death from any cause by 90 days after diagnosis (14.5% vs. 16.1%; ARD -1.6, 95% CI -4 to 0.8).
Secondary outcomes
No significant difference in death in hospital (9.3% vs. 10.3%; ARD -1, 95% CI -2.9 to 0.9).
Significant decrease in median number of days in the hospital (10 days vs. 11 days; AD -1 days, 95% CI -1.5 to -0.5).
No significant difference in relapse of bacteremia (2.6% vs. 2.2%; AD 0.4%, 95% CI -0.6 to 1.4).
Safety outcomes
No significant difference in antimicrobial-related adverse outcomes.
Conclusion
In hospitalized patients with bloodstream infection, 7-day antibiotic therapy was noninferior to 14-day antibiotic therapy with respect to the rate of death from any cause by 90 days after diagnosis.
Reference
BALANCE Investigators, for the Canadian Critical Care Trials Group, the Association of Medical Microbiology and Infectious Disease Canada Clinical Research Network et al. Antibiotic Treatment for 7 versus 14 Days in Patients with Bloodstream Infections. N Engl J Med. 2024 Nov 20. Online ahead of print.
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