Efficacy and safety of ertapenem versus piperacillin-tazobactam for the treatment of intra-abdominal infections requiring surgical intervention.
Complicated intra-abdominal infections usually mandate prompt surgical intervention supplemented by appropriate antimicrobial therapy. The aim of this study was to demonstrate that ertapenem was not inferior to piperacillin-tazobactam for the treatment of community-acquired intra-abdominal infections. A randomized open-label active-comparator clinical trial was conducted at 48 medical centers on four continents from December 2001 to February 2003. Adult patients with intra-abdominal infections requiring surgery were randomized to receive either ertapenem 1 g daily or piperacillin/tazobactam 13.5 g daily in 3-4 divided doses. The primary analysis of efficacy was the clinical response rate in clinically and microbiologically evaluable patients at the test-of-cure assessment 2 weeks after completion of therapy. All treated patients were included in the safety analysis. Patient demographics, disease characteristics, and treatment duration in both treatment groups were generally similar. The most commonly isolated pathogens at baseline were E coli (greater than 50% of cases in each group) and B fragilis ( approximately 9%). Favorable clinical response rates were 107/119 (90%) for ertapenem recipients and 107/114 (94%) for piperacillin/tazobactam recipients. The frequencies of drug-related adverse events, most commonly diarrhea and elevated serum alanine aminotransferase levels, were similar in both treatment groups. Six of 180 ertapenem recipients (3%) and two of 190 piperacillin/tazobactam recipients (1%) had serious drug-related adverse experiences. In this study, ertapenem and piperacillin/tazobactam were comparably safe and effective treatments for adult patients with complicated intra-abdominal infections.
Dela Pena
Arturo S
AS
Philippine General Hospital, Manila, Philippines.
Asperger
Walter
W
Köckerling
Ferdinand
F
Raz
Raul
R
Kafka
Reinhold
R
Warren
Brian
B
Shivaprakash
Malathi
M
Vrijens
France
F
Giezek
Hilde
H
DiNubile
Mark J
MJ
Chan
Christina Y
CY
D000005:Abdomen / Q000382:microbiology*; D000038:Abscess / Q000188:drug therapy / Q000382:microbiology / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy / Q000601:surgery*; D001442:Bacteroides Infections / Q000188:drug therapy / Q000601:surgery; D001441:Bacteroides fragilis; D003967:Diarrhea / Q000139:chemically induced; D000077727:Ertapenem; D004927:Escherichia coli Infections / Q000188:drug therapy / Q000601:surgery; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy / Q000382:microbiology / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D010397:Penicillanic Acid / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D010538:Peritonitis / Q000188:drug therapy / Q000382:microbiology / Q000601:surgery; D010878:Piperacillin / Q000009:adverse effects / Q000627:therapeutic use; D000077725:Piperacillin, Tazobactam Drug Combination; D011446:Prospective Studies; D016896:Treatment Outcome; D047090:beta-Lactams / Q000009:adverse effects / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D047090:beta-Lactams; D000077725:Piperacillin, Tazobactam Drug Combination; D010397:Penicillanic Acid; D000410:Alanine Transaminase; D000077727:Ertapenem; D010878:Piperacillin