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

NCT01254344 | Completed Phase 3 Results

• 1 other identifier: 0826-056
• Study Type: interventional
• Target: 599
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Infection; Surgical Site Infection

Keywords

Colorectal surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants With Favorable Clinical Response

  4 weeks posttreatment

Study Arms (2)

Ertapenem sodium 1 g

EXPERIMENTAL

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; Drug: placebo to metronidazole

Ceftriaxone sodium 2 g

ACTIVE COMPARATOR

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; Drug: metronidazole

Interventions

ertapenem sodium DRUG

Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Also known as: MK-0826, INVANZ®

Ertapenem sodium 1 g

ceftriaxone sodium DRUG

Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Also known as: Rocephin®

Ceftriaxone sodium 2 g

placebo to metronidazole DRUG

Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Ertapenem sodium 1 g

metronidazole DRUG

Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Also known as: Flagyl®

Ceftriaxone sodium 2 g

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 Antimicrob Chemother. 2014 Dec;69(12):3379-86. doi: 10.1093/jac/dku302. Epub 2014 Aug 23.

  PMID: 25151205 RESULT

MeSH Terms

Conditions

Infections; Surgical Wound Infection

Interventions

Ertapenem; L 749345; Ceftriaxone; Metronidazole

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cefotaxime; Cephacetrile; Cephalosporins; Thiazines; Sulfur Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Naimi Missoum
• Organization: Merck Sharp & Dohme (China) Ltd.

naimi_missoum@merck.com

+8621 2211 8546

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 6, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 22, 2017
• Results First Posted: November 16, 2012

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share