title: Ertapenem versus piperacillin/tazobactam in the treatment of complicated intraabdominal infections: results of a double-blind, randomized comparative phase III trial.
abstract: OBJECTIVE
  To examine the clinical efficacy and safety of ertapenem, a novel beta-lactam agent with wide activity against common pathogens encountered in intraabdominal infection.
  
  
  BACKGROUND
  Ertapenem has a pharmacokinetic profile and antimicrobial spectrum that support the potential for use as a once-a-day agent for the treatment of common mixed aerobic and anaerobic infections. METHODS This prospective, randomized, controlled, and double-blind trial was conducted to compare the safety and efficacy of ertapenem with piperacillin/tazobactam as therapy following adequate surgical management of complicated intraabdominal infections.
  
  
  RESULTS
  Six hundred thirty-three patients were included in the modified intent-to-treat population, with 396 meeting all criteria for the evaluable population. Patients with a wide range of infections were enrolled; perforated or abscessed appendicitis was most common (approximately 60% in microbiologically evaluable population). A prospective, expert panel review was conducted to assess the adequacy of surgical source control in patients who were failures as a component of evaluability. For the modified intent-to-treat groups, 245 of 311 patients treated with ertapenem (79.3%) were cured, as were 232 of 304 (76.2) treated with piperacillin/tazobactam. One hundred seventy-six of 203 microbiologically evaluable patients treated with ertapenem (86.7%) were cured, as were 157 of the 193 (81.2%) treated with piperacillin/tazobactam.
  
  
  CONCLUSIONS
  In this study, the efficacy of ertapenem 1 g once a day was equivalent to piperacillin/tazobactam 3.375 g every 6 hours in the treatment of a range of intraabdominal infections. Ertapenem was generally well tolerated and had a similar safety and tolerability profile to piperacillin/tazobactam. A formal process for review of adequacy of source control was found to be of benefit. The results of this trial suggest that ertapenem may be a useful option that could eliminate the need for combination and/or multidosed antibiotic regimens for the empiric treatment of intraabdominal infections.
authors.affiliation: Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267-0558, USA. joseph.solomkin@uc.edu
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Solomkin
authors.forename: Albert E
authors.initials: AE
authors.lastname: Yellin
authors.forename: Ori D
authors.initials: OD
authors.lastname: Rotstein
authors.forename: Nicolas V
authors.initials: NV
authors.lastname: Christou
authors.forename: E Patchen
authors.initials: EP
authors.lastname: Dellinger
authors.forename: Jose M
authors.initials: JM
authors.lastname: Tellado
authors.forename: Osvaldo
authors.initials: O
authors.lastname: Malafaia
authors.forename: Alvaro
authors.initials: A
authors.lastname: Fernandez
authors.forename: Kyuran A
authors.initials: KA
authors.lastname: Choe
authors.forename: Alexandra
authors.initials: A
authors.lastname: Carides
authors.forename: Vilas
authors.initials: V
authors.lastname: Satishchandran
authors.forename: Hedy
authors.initials: H
authors.lastname: Teppler
mesh_terms: D018784:Abdominal Abscess / Q000188:drug therapy* / Q000209:etiology / Q000382:microbiology / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D013505:Digestive System Surgical Procedures / Q000379:methods / Q000592:standards; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D000077727:Ertapenem; D005260:Female; D016905:Gram-Negative Bacterial Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology / Q000601:surgery; D016908:Gram-Positive Bacterial Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology / Q000601:surgery; D006760:Hospitalization; D006801:Humans; D007769:Lactams; D008297:Male; D008875:Middle Aged; D010397:Penicillanic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use*; D010538:Peritonitis / Q000188:drug therapy* / Q000209:etiology / Q000382:microbiology / Q000601:surgery; D010878:Piperacillin / Q000627:therapeutic use*; D000077725:Piperacillin, Tazobactam Drug Combination; D011446:Prospective Studies; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome; D047090:beta-Lactams
chemical_list: D000900:Anti-Bacterial Agents; D007769:Lactams; D047090:beta-Lactams; D000077725:Piperacillin, Tazobactam Drug Combination; D010397:Penicillanic Acid; D000077727:Ertapenem; D010878:Piperacillin