COMPARISON OF SHORT COURSE ANTIMICROBIAL THERAPY VS. CONVENTIONAL ANTIMICROBIAL THERAPY IN PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTIONS – A RANDOMIZED CONTROLLED TRIAL.
Vikram Kate*1, Sathasivam Sureshkumar2, Vinodhini P2, Thulasingam Mahalakshmy3
1Department of General & Gastrointestinal Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India; 2Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India; 3Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India
Introduction:
Treatment of complicated intra-abdominal infections requires both anatomical source control and antimicrobial therapy. The duration of antibiotics conventionally administered is until the resolution of systemic inflammatory response syndrome (SIRS) ranging from 7-14 days. Reports are emerging on the successful treatment of these complicated intra-abdominal infections with a shorter duration of antibiotics of 4-6 days following source control. Hence, this study was carried out to determine the efficacy of short-course when compared to the conventional duration of antimicrobials following source control.
Methodology:
This was a parallel-arm, open-labeled, non-inferiority, randomized trial conducted from June 2017 to March 2019. Patients of >18 years of age, with complicated intra-abdominal infections who underwent a source-control procedure and were hemodynamically stable, were included. Patients were allocated to study and control groups in a 1:1 ratio and were given antibiotics for 5 days and 7-10 days respectively and were followed up for 30 days. The primary outcome was a composite endpoint of the occurrence of surgical site infection (SSI), recurrent intra-abdominal infections and mortality between the study and the control groups. The secondary outcomes were the duration of antimicrobial therapy and antimicrobial free days, length of hospitalization and hospital free days at 30 days interval.
Results:
A total of 140 patients were included with 70 in each group. There was no loss to follow-up. The demographic details were comparable in both groups (Table 1). There was no significant difference in surgical site infection (37% vs. 35.6%, recurrent intra-abdominal infection (5.7% vs. 2.8%; p=0.76) [Figure 1] and the incidence of composite primary outcome (37% vs. 35.7% ; p=0.7) and the time to occurrence of the same in days was 4.1+1.6 vs. 4.5 + 1.3 (p=0.25) between the study and the control groups respectively. There was no mortality in both groups. The duration of antimicrobial therapy between the study and the control group was 5 days vs. 8 days (p-<0.001) and reduction in the length of hospitalization after the index procedure was 5 days vs. 7 days (p=0.014) respectively [Table 1]. The time to SSI occurrence, recurrent intra-abdominal infections, incidence of sites of extra-abdominal infection, infection with resistant pathogens, organ of infection, source control procedure were comparable between the groups.
Conclusion:
Short course antimicrobial therapy of 5 days when compared to a longer duration of 7-10 days had a similar outcome of surgical site infection, recurrent intra-abdominal and mortality in patients with complicated intra-abdominal infections following source control procedure. Overall the duration of the antimicrobial therapy and length of hospitalization also was shorter in the short course antimicrobial group.
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