Status:
COMPLETED
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Infection
Surgical Site Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 co...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT01254344
Start Date
December 1 2010
End Date
December 1 2011
Last Update
March 22 2017
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