Phase 3
Completed N=599
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
Source: ClinicalTrials.gov NCT01254344 ↗Enrolled (actual)
599
Serious AEs
3.4%
Results posted
Nov 2012
Primary outcomePrimary: Percentage of Participants With Success of Prophylaxis — 90.4; 90.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Success of Prophylaxis |
90.4; 90.3 | — |
| SECONDARY Percentage of Participants With Favorable Clinical Response |
96.8; 95.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01254344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.