The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese adults. This study is designed to demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this participant population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
599
Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
Percentage of Participants With Success of Prophylaxis
Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy
Time frame: From study drug dose (day of surgery) up to 4 weeks post therapy
Percentage of Participants With Favorable Clinical Response
Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection
Time frame: 4 weeks posttreatment
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Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision