Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults … (NCT01254344) | Clinical Trial Compass
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 range18 Years – 80 Years
SexALL
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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)…
What they're measuring
1
Percentage of Participants With Success of Prophylaxis
Timeframe: From study drug dose (day of surgery) up to 4 weeks post therapy