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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 599
- 主要终点
- Percentage of Participants With Success of Prophylaxis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ertapenem sodium 1 g
Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
干预措施: ertapenem sodium (Drug)
Ertapenem sodium 1 g
Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
干预措施: placebo to metronidazole (Drug)
Ceftriaxone sodium 2 g
Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
干预措施: ceftriaxone sodium (Drug)
Ceftriaxone sodium 2 g
Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
干预措施: metronidazole (Drug)
结局指标
主要结局
Percentage of Participants With Success of Prophylaxis
时间窗: From study drug dose (day of surgery) up to 4 weeks post therapy
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
次要结局
- Percentage of Participants With Favorable Clinical Response(4 weeks posttreatment)