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. SUMMARY BACKGROUND DATA: 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 withpiperacillin/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 withpiperacillin/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.
RCT Entities:
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. SUMMARY BACKGROUND DATA: 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: D M Livermore; M W Carter; S Bagel; B Wiedemann; F Baquero; E Loza; H P Endtz; N van Den Braak; C J Fernandes; L Fernandes; N Frimodt-Moller; L S Rasmussen; H Giamarellou; E Giamarellos-Bourboulis; V Jarlier; J Nguyen; C E Nord; M J Struelens; C Nonhoff; J Turnidge; J Bell; R Zbinden; S Pfister; L Mixson; D L Shungu Journal: Antimicrob Agents Chemother Date: 2001-06 Impact factor: 5.191
Authors: P Seguin; C Brianchon; Y Launey; B Laviolle; N Nesseler; P-Y Donnio; Y Malledant Journal: Eur J Clin Microbiol Infect Dis Date: 2011-11-12 Impact factor: 3.267
Authors: Arturo S Dela Pena; Walter Asperger; Ferdinand Köckerling; Raul Raz; Reinhold Kafka; Brian Warren; Malathi Shivaprakash; France Vrijens; Hilde Giezek; Mark J DiNubile; Christina Y Chan Journal: J Gastrointest Surg Date: 2006-04 Impact factor: 3.452
Authors: Anthony W Chow; Gerald A Evans; Avery B Nathens; Chad G Ball; Glen Hansen; Godfrey Km Harding; Andrew W Kirkpatrick; Karl Weiss; George G Zhanel Journal: Can J Infect Dis Med Microbiol Date: 2010 Impact factor: 2.471
Authors: Christopher Lucasti; Ellie Hershberger; Benjamin Miller; Sara Yankelev; Judith Steenbergen; Ian Friedland; Joseph Solomkin Journal: Antimicrob Agents Chemother Date: 2014-06-30 Impact factor: 5.191