title: Clinical efficacy of intravenous doripenem in patients with acute biliary tract infection: a multicenter, randomized, controlled trial with imipenem/cilastatin as comparator.
abstract: BACKGROUND
  We conducted a randomized controlled trial to evaluate the clinical efficacy and safety of intravenous doripenem (DRPM) in patients with biliary tract infection requiring biliary drainage in comparison with imipenem/cilastatin (IPM/CS).
  
  
  METHODS
  After the initial collection of bile, patients were randomly assigned by the registration system of the Clinical Research Organization to receive intravenous drip infusion of DRPM 0.5 g or IPM/CS 0.5 g three times daily in a randomized, open-label manner.
  
  
  RESULTS
  A total of 127 patients were enrolled in the trial (DRPM 62, IPM/CS 65). The characteristics of the 122 patients evaluated for efficacy were well balanced, except for the percentage of patients previously receiving antimicrobials, which was higher in the DRPM group than in the IPM/CS group. The clinical response rate was not significantly different between the DRPM group (93.1 %, 54/58 patients) and the IPM/CS group (93.8 %, 60/64). Non-inferiority assessment using confidence intervals demonstrated the non-inferiority of DRPM-IPM/CS. The incidence of adverse events, for which a causal relationship with either treatment was not ruled out, was 3.3 % (2/60) in the DRPM group and 3.1 % (2/65) in the IPM/CS group, and none was serious.
  
  
  CONCLUSIONS
  The clinical efficacy of DRPM in treating moderate or severe biliary tract infection requiring drainage was comparable to that of IPM/CS. DRPM was associated with no serious adverse events and a low incidence of adverse events. The results of this trial demonstrate that DRPM is a useful therapeutic option for moderate or severe biliary tract infection.
authors.affiliation: Department of General Internal Medicine, Hiroshima University Graduate School of Medical Science, Programs of Applied Medicine, Clinical Pharmacotherapy, Hiroshima, Japan, stazuma@hiroshima-u.ac.jp.
authors.forename: Susumu
authors.initials: S
authors.lastname: Tazuma
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Igarashi
authors.forename: Kazuo
authors.initials: K
authors.lastname: Inui
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Ohara
authors.forename: Toshio
authors.initials: T
authors.lastname: Tsuyuguchi
authors.forename: Shomei
authors.initials: S
authors.lastname: Ryozawa
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000503:physiopathology; D001831:Body Temperature / Q000187:drug effects; D002097:C-Reactive Protein / Q000378:metabolism; D015780:Carbapenems / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002761:Cholangitis / Q000188:drug therapy* / Q000503:physiopathology; D041881:Cholecystitis, Acute / Q000188:drug therapy* / Q000503:physiopathology; D015377:Cilastatin / Q000009:adverse effects / Q000627:therapeutic use*; D000077728:Cilastatin, Imipenem Drug Combination; D000077726:Doripenem; D004338:Drug Combinations; D005260:Female; D006801:Humans; D015378:Imipenem / Q000009:adverse effects / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D015780:Carbapenems; D004338:Drug Combinations; D015377:Cilastatin; D015378:Imipenem; D002097:C-Reactive Protein; D000077728:Cilastatin, Imipenem Drug Combination; D000077726:Doripenem