Effect of oral rifaximin for prevention of infected pancreatic necrosis and mortality in severe acute pancreatitis: An open-label randomized controlled trial.

INTRODUCTION

Infection of pancreatic necrosis is associated with high mortality in patients with acute pancreatitis. Selective gut decontamination may have a favourable impact on outcomes in patients with acute pancreatitis but its efficacy remains unproven. This study aimed to assess the efficacy of rifaximin, a broad-spectrum poorly absorbed oral antibiotic with a highly favourable safety profile in preventing infection of pancreatic necrosis and overall mortality in patients with predicted severe acute pancreatitis.

METHODS

It was an investigator-initiated open-label randomized controlled trial. Eligible patients hospitalized with predicted severe acute pancreatitis were randomized to standard treatment plus rifaximin 550 mg per oral twice daily for 14 days or standard treatment alone. The primary endpoints of the study were the development of infected pancreatic necrosis and in-hospital mortality.

RESULTS

One hundred patients were randomized to standard treatment plus rifaximin versus standard treatment alone. There was no difference in the primary endpoints: incidence of infected pancreatic necrosis (31 versus 35, p = 0.507) and mortality (9 versus 14, p = 0.603) between the two groups. The median length of ICU stay (3 versus 5 days, p = 0.209) and, incidence of organ failure (56 % versus 60 %, p = 0.525), were also similar in the two groups. Patients who received rifaximin had significantly lower median duration of hospitalization (8 days compared to 11.5 days, p = 0.002) than those who did not.

CONCLUSION

Rifaximin did not have a significant effect on either the development of infected pancreatic necrosis or mortality in patients with predicted severe acute pancreatitis. However, the length of hospital stay was significantly shorter in the rifaximin group.

CLINICAL TRIAL REGISTRATION: This study has been registered in India's clinical trial registry under the registration number CTRI/2020/02/023459).