Aim: We conducted a multicenter trial to evaluate the efficacy and safety of i.v. doripenem (DRPM), a new class of carbapenem, in patients with moderate to severe biliary tract infection based on severity assessment using the Guidelines for the Management of Acute Cholangitis and Cholecystitis (1st Edition).
Methods: One hundred and nineteen patients with moderate to severe acute cholangitis and/or cholecystitis were subjected to this study. After the initial collection of bile, patients were administrated DRPM 0.5 g three times daily by i.v. drip infusion.
Results: The characteristics of the 119 patients were well balanced, including 60 with cholangitis, 44 with cholecystitis and 15 with cholangitis complicated by cholecystitis; there were 88.2% (105/119) moderate cases and 11.8% (14/119) severe. Based upon the assumption of the use of bile drainage, the rate of response to DRPM was 92.4% (110/119) in the group of all patients. The clinical response rates were 95.0% (57/60) for cholangitis, 93.2% (41/44) for cholecystitis and 80% (12/15) for cholangitis complicated by cholecystitis. Also, the clinical response rate was 80% (8/10) in 10 patients without drainage. In contrast, bacteriological efficacy was assessed in 50 patients, and the response rates were 87.0% (20/23) in patients with cholangitis, 100% (20/20) in patients with cholecystitis and 85.7% (6/7) in patients with cholangitis complicated by cholecystitis. Adverse events were found in six patients (5.0%), but were not serious and disappeared after treatment.
Conclusion: These findings suggest that DPRM is useful as a new option for moderate to severe biliary tract infection.
© 2011 The Japan Society of Hepatology.