Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
Infection, Surgical Site Infection
About this trial
This is an interventional prevention trial for Infection focused on measuring Colorectal surgery
Eligibility Criteria
Inclusion Criteria:
- Participant is scheduled to undergo elective colon or colorectal surgery by
laparotomy that is scheduled in advance with adequate time prior to surgery to
complete preoperative bowel preparation.
- Participant is a Chinese adult between the ages of more than 18 years old and
less than 81 years old.
- Participant is highly unlikely to conceive.
Exclusion Criteria:
- Participant is undergoing emergency colon or colorectal surgery.
- Participant requires a second planned colorectal surgery or other surgery requiring antibiotic prophylaxis within the 4-week follow-up period.
- Participant is undergoing laparoscopic-assisted surgery.
- Participant is undergoing an isolated rectal procedure.
- Participant has a decompensated intestinal obstruction.
- Participant has active inflammatory bowel disease involving the colon (i.e.,
ulcerative colitis or Crohn's disease).
- Participant is scheduled to undergo an elective colorectal procedure for revision of a previous operation involving a large bowel resection.
- Participant has a bacterial infection at the time of surgery.
- Participant requires or is anticipated to need the administration of other (nonstudy therapy) systemic antimicrobial therapy within 1 week prior to surgery or at any time during this study.
- Participant is anticipated to receive either antibiotic or antiseptic peritoneal lavage during the surgery.
- Participant has a history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to ertapenem sodium, ceftriaxone sodium, metronidazole, penicillin, or any cephalosporin, beta(β)-lactam, or nitroimidazole agents.
- Participant is breast feeding or plans to breast feed prior to the completion of the study period.
- Participant has neutropenia.
- Participant with immunosuppression due to an underlying disease, chronic
immunosuppressive therapy, or use of high-dose corticosteroids.
- Participant has a rapidly progressive or terminal illness.
- Participant is considered unlikely to survive through the expected 4-week study period.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ertapenem sodium 1 g
Ceftriaxone sodium 2 g
Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose