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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254344
• Other study ID #: 0826-056
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2010
• Last updated: November 2, 2015
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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(ß)-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• ertapenem sodium
Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
• ceftriaxone sodium
Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
• placebo to metronidazole
Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
• metronidazole
Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Leng XS, Zhao YJ, Qiu HZ, Cao YK, Zhu WH, Shen JF, Paschke A, Dai WM, Caldwell N, Wang J. Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study. J Antimi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No