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 usingimipenem/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.
RCT Entities:
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.
Authors: S Ichiyama; T Mori; K Yamaguchi; M Hayashi; K Yamanaka; Y Kurokawa; N Uehara; C Takahashi; K Negayama; Y Kaneko; Y Hirakata Journal: Jpn J Antibiot Date: 2001-08
Authors: D P Raymond; S J Pelletier; T D Crabtree; T G Gleason; L L Hamm; T L Pruett; R G Sawyer Journal: Crit Care Med Date: 2001-06 Impact factor: 7.598
Authors: Y Hirakata; K Izumikawa; T Yamaguchi; H Takemura; H Tanaka; R Yoshida; J Matsuda; M Nakano; K Tomono; S Maesaki; M Kaku; Y Yamada; S Kamihira; S Kohno Journal: Antimicrob Agents Chemother Date: 1998-08 Impact factor: 5.191