6/29/23, 11:57 PM STOP-IT Pathway Feedback Search Clinical Topics Home Studies STOP IT STOP IT Disease Disease Disease Acute appendicitis Acute cholecystitis Acute dive 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 N = 518 56.0% male 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 experimental (receipt of a fixed course of antibiotics for 4 1 calendar days) N=260 control (receipt of antibiotics until 2 days after the resolution of fever, leukocytosis, and ileus, with a maximum of 10 days of therapy) https://web.pathway.md/studies/reca8CCLaWV81e5sS 1/2 6/29/23, 11:57 PM STOP-IT Pathway Primary outcome Rate of composite of surgical site infection, recurrent intra-abdominal infection, or death within 30 days after the index source-control procedure 22.3 % 22.3 21.8 16.7 % 11.2 % 5.6 % No significant difference 0.0 % Experimental Control 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, experimental was equivalent to control 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. Open reference URL https://web.pathway.md/studies/reca8CCLaWV81e5sS 2/2