CompletedPhase 3

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

599 participantsStarted 2010-12

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Success of Prophylaxis

Timeframe: From study drug dose (day of surgery) up to 4 weeks post therapy

Trial details

NCT IDNCT01254344

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12

Results submitted2012-10-16

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