Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infection, Surgical Site Infection

Intervention / Treatment
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* Drug: ertapenem sodium
* Drug: ceftriaxone sodium
* Drug: placebo to metronidazole
* Drug: metronidazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ertapenem sodium 1 g<br>Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose | Drug: ertapenem sodium<br>* Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision<br>* Other names: INVANZ®;Drug: placebo to metronidazole<br>* Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision<br>|
| Active Comparator: Ceftriaxone sodium 2 g<br>Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose | Drug: ceftriaxone sodium<br>* Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision<br>* Other names: Rocephin®;Drug: metronidazole<br>* Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision<br>* Other names: Flagyl®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From study drug dose (day of surgery) up to 4 weeks post therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks posttreatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery