6/29/23, 11:42 PM SHORTEN Pathway Feedback Search Clinical Topics Home Studies SHORTEN SHORTEN Disease Disease Antimicrobial-resistant Gram-ne Sepsis and septic shock Trial question Is a 7-day course of antibiotics superior to a 14-day course of antibiotics in patients with bloodstream infections caused by Enterobacterales? Study design Multi-center Open label RCT Population Characteristics of study participants 47.5% female N = 248 52.5% male 248 patients (117 female, 130 male) Inclusion criteria: adult patients with bloodstream infections caused by Enterobacterales and having undergone appropriate source control Key exclusion criteria: pregnancy, uncontrolled source of bacteremia at inclusion or in the following 24 hours, post-chemotherapy neutropenia expected to persist > 7 days, bacteremia secondary to infections requiring prolonged antibiotic therapy Interventions N=119 7-day course (standard antibiotic treatment approved for Enterobacteriaceae infections for a period of 7 days) https://web.pathway.md/studies/recxIrZA8ZEHbSYmI 1/2 6/29/23, 11:42 PM SHORTEN Pathway N=129 14-day course (standard antibiotic treatment approved for Enterobacteriaceae infections for a period of 14 days) Primary outcome Days of antibiotic treatment at end of follow-up 14.0 days 14 10.5 days 7.0 days 7 3.5 days Significant increase 0.0 days 7-day course 14-day course Significant increase in days of antibiotic treatment at the end of follow-up (7 days vs. 14 days; AD 7 days, 95% CI 7 to -7) Secondary outcomes No significant difference in absence of clinical cure (7.3% vs. 9.8%; ARD -2.6, 95% CI -10 to 5.1) No significant difference in relapse of bloodstream infection (6.5% vs. 5%; ARD 1.5, 95% CI -4.8 to 8.4) No significant difference in relapse of fever (19.1% vs. 19.3%; ARD -0.2, 95% CI -10.4 to 10.1) Safety outcomes No significant differences in severe adverse events, drug-related reactions. Conclusion In adult patients with bloodstream infections caused by Enterobacterales and having undergone appropriate source control, 7-day course was superior to 14-day course with respect to days of antibiotic treatment at the end of follow-up. Reference Jos Molina, Enrique Montero-Mateos, Julia Praena-Segovia et al. Seven-versus 14-day course of antibiotics for the treatment of bloodstream infections by Enterobacterales: a randomized, controlled trial. Clin Microbiol Infect. 2022 Apr;28(4):550-557. Open reference URL https://web.pathway.md/studies/recxIrZA8ZEHbSYmI 2/2