Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Surgical Site Infection
Intervention: ertapenem sodium (Drug); ceftriaxone sodium (Drug); placebo to metronidazole (Drug); metronidazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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 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.
Clinical Details
Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Ertapenem Sodium (MK-0826) Versus Ceftriaxone Sodium/Metronidazole for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery in Chinese Adults
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Percentage of Participants With Success of Prophylaxis
Secondary outcome: Percentage of Participants With Favorable Clinical Response
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: December 2010
Last updated: June 8, 2015
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