SHORTEN
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
47.0% female
53.0% male
N = 248
248 patients (117 female, 131 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).
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
7 days
14 days
14.0 days
10.5 days
7.0 days
3.5 days
0.0 days
7-day
course
14-day
course
Significant
increase ▲
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
José 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.
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