Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, NEJMoa2404991. https://doi.org/10.1056/NEJMoa2404991 The BALANCE Investigators for the Canadian Critical Care Trials Group et al.
Points
- The study compared the effectiveness of 7-day versus 14-day antibiotic regimens for hospitalized patients with bloodstream infections across 74 hospitals in seven countries.
- The primary outcome, 90-day all-cause mortality, was 14.5% for the 7-day group and 16.1% for the 14-day group, with a difference of −1.6 percentage points, demonstrating the shorter treatment’s noninferiority.
- Per-protocol analysis confirmed similar results, reinforcing the noninferiority of the 7-day regimen compared to the 14-day regimen.
- Secondary clinical outcomes and subgroup analyses based on patient, pathogen, and infection site characteristics supported the conclusion of noninferiority.
- The study concludes that a 7-day antibiotic regimen is a safe and effective alternative to a 14-day regimen for hospitalized patients with bloodstream infections, reducing treatment duration without compromising outcomes.
Summary
This multicenter, noninferiority trial aimed to assess whether a 7-day antibiotic treatment regimen is as effective as a 14-day regimen for hospitalized patients with bloodstream infections. The trial included 3608 patients across 74 hospitals in seven countries, with 1814 randomly assigned to the 7-day treatment group and 1794 to the 14-day treatment group. The primary outcome was death from any cause within 90 days of diagnosis. The trial excluded patients with severe immunosuppression, cultures yielding Staphylococcus aureus, and those requiring prolonged treatment for specific infection foci. In total, 55.0% of patients were in the ICU, and infections were most commonly acquired from the urinary tract (42.2%), abdomen (18.8%), and lung (13.0%).
By the 90-day mark, 14.5% of patients in the 7-day group and 16.1% of patients in the 14-day group had died, a difference of −1.6 percentage points (95.7% CI, −4.0 to 0.8), demonstrating that the shorter duration was non-inferior to the longer one. A per-protocol analysis showed similar results, with a difference of −2.0 percentage points (95% CI, −4.5 to 0.6). A small proportion of patients (23.1% in the 7-day group and 10.7% in the 14-day group) were treated longer than the assigned duration, which did not alter the primary findings. Secondary clinical outcomes were consistent with these results across prespecified subgroups based on patient, pathogen, and infection site characteristics.
The study concludes that, in hospitalized patients with bloodstream infections, a 7-day antibiotic treatment regimen is non-inferior to a 14-day regimen in terms of mortality, supporting a shorter treatment duration as a practical approach for this patient population.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2404991
References The BALANCE Investigators, for the Canadian Critical Care Trials Group, the Association of Medical Microbiology and Infectious Disease Canada Clinical Research Network, the Australian and New Zealand Intensive Care Society Clinical Trials Group, and the Australasian Society for Infectious Diseases Clinical Research Network. (2024). Antibiotic treatment for 7 versus 14 days in patients with bloodstream infections. New England Journal of Medicine, NEJMoa2404991. https://doi.org/10.1056/NEJMoa2404991
