Daneman Nick, Rishu Asgar, Pinto Ruxandra, Rogers Benjamin A, Shehabi Yahya, Parke Rachael, Cook Deborah, Arabi Yaseen, Muscedere John, Reynolds Steven, Hall Richard, Dwivedi Dhiraj B, McArthur Colin, McGuinness Shay, Yahav Dafna, Coburn Bryan, Geagea Anna, Das Pavani, Shin Phillip, Detsky Michael, Morris Andrew, Fralick Michael, Powis Jeff E, Kandel Christopher, Sligl Wendy, Bagshaw Sean M, Singhal Nishma, Belley-Cote Emilie, Whitlock Richard, Khwaja Kosar, Morpeth Susan, Kazemi Alex, Williams Anthony, MacFadden Derek R, McIntyre Lauralyn, Tsang Jennifer, Lamontagne Francois, Carignan Alex, Marshall John, Friedrich Jan O, Cirone Robert, Downing Mark, Graham Christopher, Davis Joshua, Duan Erick, Neary John, Evans Gerald, Alraddadi Basem, Al Johani Sameera, Martin Claudio, Elsayed Sameer, Ball Ian, Lauzier Francois, Turgeon Alexis, Stelfox Henry T, Conly John, McDonald Emily G, Lee Todd C, Sullivan Richard, Grant Jennifer, Kagan Ilya, Young Paul, Lawrence Cassie, O'Callaghan Kevin, Eustace Matthew, Choong Keat, Aslanian Pierre, Buehner Ulrike, Havey Tom, Binnie Alexandra, Prazak Josef, Reeve Brenda, Litton Edward, Lother Sylvain, Kumar Anand, Zarychanski Ryan, Hoffman Tomer, Paterson David, Daley Peter, Commons Robert J, Charbonney Emmanuel, Naud Jean-Francois, Roberts Sally, Tiruvoipati Ravindranath, Gupta Sachin, Wood Gordon, Shum Omar, Miyakis Spiros, Dodek Peter, Kwok Clement, Fowler Robert A
Division of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto.
Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto.
N Engl J Med. 2025 Mar 13;392(11):1065-1078. doi: 10.1056/NEJMoa2404991. Epub 2024 Nov 20.
Bloodstream infections are associated with substantial morbidity and mortality. Early, appropriate antibiotic therapy is important, but the duration of treatment is uncertain.
In a multicenter, noninferiority trial, we randomly assigned hospitalized patients (including patients in the intensive care unit [ICU]) who had bloodstream infection to receive antibiotic treatment for 7 days or 14 days. Antibiotic selection, dosing, and route were at the discretion of the treating team. We excluded patients with severe immunosuppression, foci requiring prolonged treatment, single cultures with possible contaminants, or cultures yielding . The primary outcome was death from any cause by 90 days after diagnosis of the bloodstream infection, with a noninferiority margin of 4 percentage points.
Across 74 hospitals in seven countries, 3608 patients underwent randomization and were included in the intention-to-treat analysis; 1814 patients were assigned to 7 days of antibiotic treatment, and 1794 to 14 days. At enrollment, 55.0% of patients were in the ICU and 45.0% were on hospital wards. Infections were acquired in the community (75.4%), hospital wards (13.4%) and ICUs (11.2%). Bacteremia most commonly originated from the urinary tract (42.2%), abdomen (18.8%), lung (13.0%), vascular catheters (6.3%), and skin or soft tissue (5.2%). By 90 days, 261 patients (14.5%) receiving antibiotics for 7 days had died and 286 patients (16.1%) receiving antibiotics for 14 days had died (difference, -1.6 percentage points [95.7% confidence interval {CI}, -4.0 to 0.8]), which showed the noninferiority of the shorter treatment duration. Patients were treated for longer than the assigned duration in 23.1% of the patients in the 7-day group and in 10.7% of the patients in the 14-day group. A per-protocol analysis also showed noninferiority (difference, -2.0 percentage points [95% CI, -4.5 to 0.6]). These findings were generally consistent across secondary clinical outcomes and across prespecified subgroups defined according to patient, pathogen, and syndrome characteristics.
Among hospitalized patients with bloodstream infection, antibiotic treatment for 7 days was noninferior to treatment for 14 days. (Funded by the Canadian Institutes of Health Research and others; BALANCE ClinicalTrials.gov number, NCT03005145.).
血流感染与严重的发病率和死亡率相关。早期、恰当的抗生素治疗很重要，但治疗持续时间尚不确定。
在一项多中心、非劣效性试验中，我们将患有血流感染的住院患者（包括重症监护病房[ICU]中的患者）随机分配接受7天或14天的抗生素治疗。抗生素的选择、剂量和给药途径由治疗团队自行决定。我们排除了严重免疫抑制患者、需要长期治疗的病灶患者、单次培养可能有污染物的患者或培养结果为……的患者。主要结局是血流感染诊断后90天内任何原因导致的死亡，非劣效性界值为4个百分点。
在7个国家的7家医院中，3608例患者进行了随机分组并纳入意向性分析；1814例患者被分配接受7天抗生素治疗，1794例接受14天治疗。入组时，55.0%的患者在ICU，45.0%在医院病房。感染发生在社区（75.4%）、医院病房（13.4%）和ICU（11.2%）。菌血症最常见的来源是泌尿系统（42.2%）、腹部（18.8%）、肺部（13.0%）、血管导管（6.3%）以及皮肤或软组织（5.2%）。到90天时，接受7天抗生素治疗的261例患者（14.5%）死亡，接受14天抗生素治疗的286例患者（16.1%）死亡（差异为-1.6个百分点[95.7%置信区间{CI}，-4.0至0.8]），这表明较短治疗持续时间的非劣效性。7天组中23.1%的患者治疗时间超过指定时间，14天组中10.7%的患者治疗时间超过指定时间。符合方案分析也显示非劣效性（差异为-2.0个百分点[95%CI，-4.5至0.6]）。这些发现对于次要临床结局以及根据患者、病原体和综合征特征定义的预先指定亚组而言总体一致。
在患有血流感染的住院患者中，7天抗生素治疗不劣于14天治疗。（由加拿大卫生研究院及其他机构资助；BALANCE临床试验注册号，NCT03005145。）
