Background: We conducted a randomized controlled trial (RCT) to evaluate the clinical efficacy of an intravenous fluoroquinolone, ciprofloxacin (CIP), in patients with biliary tract infection requiring biliary drainage using imipenem/cilastatin (IPM/CS) as a control.
Methods: After the initial collection of bile, patients were randomly assigned to receive CIP at 300 mg twice daily by intravenous drip infusion or IPM/CS at 500 mg twice daily by intravenous drip infusion with the envelope method.
Results: The characteristics of the 104 patients evaluated for efficacy were well balanced. The clinical response rates were 100.0% (50/50 patients) in the CIP group and 94.4% (51/54) in the IPM/CS group. The difference in clinical response rate between groups (CIP, IPM/CS) was 5.56% (90% confidence interval: -0.26%, 13.95%), and the non-inferiority of CIP to IPM/CS was confirmed. Adverse events for which causal relationships with the study drugs could not be ruled out developed in 5.4% (3/56) of patients in the CIP group and 5.2% (3/58) of patients in the IPM/CS group, and none of them were serious.
Conclusions: The clinical efficacy of CIP in treating biliary tract infection requiring drainage was comparable to that of IPM/CS. These findings suggest that CIP is useful as a new therapeutic option for biliary tract infection.