STOP-IT
Trial question
What is the effect of fixed-duration antibiotic therapy in patients with intra-abdominal infections who had undergone an adequate source-control procedure?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 518
518 patients (229 female, 289 male)
Inclusion criteria: patients with complicated intra-abdominal infection and adequate source control
Key exclusion criteria: age < 16 years; lack of adequate source control; high likelihood of death or lack of any clinical improvement within 72 hours of initial intervention; planned relaparotomy; perforated gastric ulcer or duodenal ulcer treated within 24 hours of the onset of symptoms
Interventions
N=258 fixed-duration antibiotic regimen (receipt of a fixed course of antibiotics for 4 +/- 1 calendar days)
N=260 antibiotic duration based on clinical response (receipt of antibiotics until 2 days after the resolution of fever, leukocytosis, and ileus, with a maximum of 10 days of therapy)
Primary outcome
Rate of composite of surgical site infection, recurrent intra-abdominal infection, or death within 30 days after the index source-control procedure
21.8
22.3
22.3 %
16.7 %
11.2 %
5.6 %
0.0 %
Fixed-duration antibiotic
regimen
Antibiotic duration based on clinical
response
No significant
difference ↔
No significant difference in the rate of composite of surgical site infection, recurrent intra-abdominal infection, or death within 30 days after the index source-control procedure (21.8% vs. 22.3%; ARD -0.5, 95% CI -7 to 8)
Secondary outcomes
Significant decrease in duration of therapy (4 days vs. 8 days; AD -4 days, 95% CI -4.7 to -3.3)
No significant difference in death (1.2% vs. 0.8%; AD 0.4%, 95% CI -1.7 to 2.7)
No significant difference in recurrent intra-abdominal infection (15.6% vs. 13.8%; AD 1.8%, 95% CI -4.5 to 7.8)
Safety outcomes
No significant differences in rates of extra-abdominal infection, C. difficile infection, secondary infections with resistant pathogens.
Significant difference in antimicrobial free days at 30 days (25 days vs. 21 days).
Conclusion
In patients with complicated intra-abdominal infection and adequate source control, fixed-duration antibiotic regimen were equivalent to antibiotic duration based on clinical response with respect to the rate of composite of surgical site infection, recurrent intra-abdominal infection, or death within 30 days after the index source-control procedure.
Reference
Robert G Sawyer, Jeffrey A Claridge, Avery B Nathens et al. Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015 May 21;372(21):1996-2005.
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