TY - JOUR
T1 - Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections
AU - Navarro, Narcisco S.
AU - Campos, Maria I.
AU - Alvarado, Ramon
AU - Quintero, Nora
AU - Branicki, Frank J.
AU - Wei, Junmin
AU - Shivaprakash, Malathi
AU - Vrijens, France
AU - Giezek, Hilde
AU - Chan, Christina Y.
AU - DiNubile, Mark J.
N1 - Funding Information:
This study was sponsored and funded by Merck & Co., Inc. which markets ertapenem. All authors were investigators for or employees of the sponsor.
PY - 2005
Y1 - 2005
N2 - Background: Prompt surgical intervention supplemented by appropriate antimicrobial therapy is usually required for successful treatment of complicated intra-abdominal infections. The objective of this study was to further evaluate the efficacy and safety of ertapenem relative to ceftriaxone/metronidazole as treatment for complicated intra-abdominal infections. Methods: Adult patients with intra-abdominal infections requiring surgery were eligible for this open-label randomized trial comparing ertapenem 1 g daily with ceftriaxone 2 g daily plus metronidazole 30 mg/kg/day. The primary efficacy outcome was the clinical response rate in clinically and microbiologically evaluable participants at the test-of-cure (TOC) visit 2 weeks after discontinuation of therapy. All treated patients were included in the safety analysis. Results: Participant demographics, disease characteristics, and duration of therapy in both treatment groups were generally similar. Escherichia coli was the most commonly isolated baseline pathogen, recovered in 52% of cases in each treatment group. Favorable clinical responses were achieved at TOC in 143 (96.6%) of 148 ertapenem recipients and in 146 (96.7%) of 151 ceftriaxone/metronidazole recipients. The frequencies of drug-related adverse events, most commonly nausea, diarrhea, vomiting, and elevated platelet count, were generally comparable in both treatment arms. Four ertapenem recipients (1.8%) and one ceftriaxone/metronidazole recipient (0.4%) experienced serious drug-related adverse events. Conclusions: In this study, ertapenem and ceftriaxone/metronidazole were comparably effective treatments for adult patients with complicated intra-abdominal infections.
AB - Background: Prompt surgical intervention supplemented by appropriate antimicrobial therapy is usually required for successful treatment of complicated intra-abdominal infections. The objective of this study was to further evaluate the efficacy and safety of ertapenem relative to ceftriaxone/metronidazole as treatment for complicated intra-abdominal infections. Methods: Adult patients with intra-abdominal infections requiring surgery were eligible for this open-label randomized trial comparing ertapenem 1 g daily with ceftriaxone 2 g daily plus metronidazole 30 mg/kg/day. The primary efficacy outcome was the clinical response rate in clinically and microbiologically evaluable participants at the test-of-cure (TOC) visit 2 weeks after discontinuation of therapy. All treated patients were included in the safety analysis. Results: Participant demographics, disease characteristics, and duration of therapy in both treatment groups were generally similar. Escherichia coli was the most commonly isolated baseline pathogen, recovered in 52% of cases in each treatment group. Favorable clinical responses were achieved at TOC in 143 (96.6%) of 148 ertapenem recipients and in 146 (96.7%) of 151 ceftriaxone/metronidazole recipients. The frequencies of drug-related adverse events, most commonly nausea, diarrhea, vomiting, and elevated platelet count, were generally comparable in both treatment arms. Four ertapenem recipients (1.8%) and one ceftriaxone/metronidazole recipient (0.4%) experienced serious drug-related adverse events. Conclusions: In this study, ertapenem and ceftriaxone/metronidazole were comparably effective treatments for adult patients with complicated intra-abdominal infections.
KW - Ceftriaxone
KW - Ertapenem
KW - Intra-abdominal infection
KW - Metronidazole
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U2 - 10.1016/j.ijsu.2005.03.010
DO - 10.1016/j.ijsu.2005.03.010
M3 - Article
C2 - 17462256
AN - SCOPUS:23244444499
SN - 1743-9191
VL - 3
SP - 25
EP - 34
JO - International Journal of Surgery
JF - International Journal of Surgery
IS - 1
ER -