Trial: 7 days of antibiotics for bloodstream infections noninferior to 14 days
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Key takeaways:
- The 90-day mortality rate was 14.5% in the 7-day arm vs. 16.1% in the 14-day arm.
- Secondary outcomes were also comparable between the two groups.
LOS ANGELES — Another study is suggesting that shorter is better — this time, a 2-week course of antibiotics for bloodstream infections was safely cut in half in a multinational randomized trial.
“Finding strong evidence that supports shorter antibiotic treatment durations is a top priority to advance antimicrobial stewardship as drug-resistant bacteria are increasingly becoming a public health threat,” Nick Daneman, MD, a clinician scientist in the division of infectious diseases at Sunnybrook Health Sciences Centre and a professor of medicine at the University of Toronto, said in a press release. “These findings underscore the effectiveness of a shorter antibiotic regimen in patients with bloodstream infections (BSIs), which is welcomed as we look to identify evidence-based prescribing guidelines for serious bacterial infections.”
The BALANCE trial enrolled more than 3,600 patients with BSIs from 74 sites in seven countries. The researchers randomly assigned the patients to 7 or 14 days of antibiotic therapy. More than 70 pathogens were identified as the cause of the BSIs, but the top three included Escherichia coli, Klebsiella species and Enterococcus species.
In the intent-to-treat analysis, 14.5% of patients in the 7-day arm and 16.1% of patients in the 14-day arm had died by 90 days — a risk difference of –1.6 percentage points (95% CI, –4 to 0.8). That fell comfortably within the study’s noninferiority margin of +4 percentage points and in fact favors shorter treatment. The findings were consistent in additional analyses and across different patient subgroups.
“So, we can see really clearly here that 7 days is noninferior to 14 days for the treatment of bloodstream infections,” Daneman said during a late-breaking presentation at IDWeek.
The study’s multiple secondary outcomes were also similar between the two groups. Daneman flagged three that showed significant improvement with shorter therapy: length of hospital stay, being hospital-free by 28 days and being antibiotic-free by 28 days.
“We think that this should be the general treatment strategy for our patients with bloodstream infection,” Daneman said, referring to the 7-day course. “It will give our patients noninferior outcomes, it will translate to large drug-acquisition cost-savings, and much more importantly, we think it has the potential to lead to reductions in antimicrobial side effects and resistance.”
References:
- Antibiotic treatment regimen for bloodstream infections can safely be cut in half. https://www.idsociety.org/news--publications-new/articles/2024/antibiotic-treatment-regimen-for-bloodstream-infections-can-safely-be-cut-by-half/. Published Oct. 16, 2024. Accessed Oct. 18, 2024.
- Daneman N, Fowler R. Abstract 376. Presented at: IDWeek; Oct. 16-19, 2024; Los Angeles.
Perspective
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Many clinicians already consider 7 days to be standard of care for bacteremia caused by gram-negative bacteria, because three prior randomized controlled trials of patients with gram-negative bacteremia all found that 7 days was as effective as 14 days of antibiotic therapy for these infections.
However, BALANCE enrolled more patients than those three trials combined and was reinforced with a very tight margin of noninferiority. Indeed, the point estimate and 95% CI skewed heavily in favor of 7 days, making it appear close to superior on the mortality endpoint.
Of importance, many of these patients were enrolled in the ICU, and as such were seriously ill. Furthermore, the efficacy of 7 days was seen across all pathogens evaluated, including all gram-negative bacteria (including Pseudomonas) and Streptococcus species and Enterococcus species.
In short, the trial reiterates that 7 days of antibiotics should be standard of care for most forms of bacteremia, excluding Staphylococcus aureus and Candida species, which were not studied, as long as there are no deeper niduses of infection (such as tissue abscesses, endocarditis, etc.).
References:
Yahav D, et al. Clin Infect Dis. 2019;doi:10.1093/cid/ciy1054.
von Dach E, et al. JAMA. 2020;doi: 10.1001/jama.2020.6348.
Molina J, et al. Clin Microbiol Infect. 2022;doi:10.1016/j.cmi.2021.09.001.
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Daneman N, Fowler R. Abstract 376. Presented at: IDWeek; Oct. 16-19, 2024; Los Angeles.
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