Trial · NCT01254344
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
NCT01254344, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2012-11-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056). Trials, record NCT01254344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01254344
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
- NCT number
- NCT01254344
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 599 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Infection, Surgical Site Infection
- Interventions
- ertapenem sodium, ceftriaxone sodium, placebo to metronidazole, metronidazole
- First posted
- 2010-12-06
- Last updated
- 2017-03-22
- Results first posted
- 2012-11-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Success of Prophylaxis | 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 |
| Secondary | Percentage of Participants With Favorable Clinical Response | 4 weeks posttreatment | Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Success of Prophylaxis | From study drug dose (day of surgery) up to 4 weeks post therapy | Primary analysis results are for evaluable-patients-only, defined as patients who received a complete dose of prophylaxis, underwent elective colorectal surgery with completion of bowel preparation procedure, had primary skin closure of the wound, and did not receive any prohibited systemic antibiotics or other prohibited anti-infective agents. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Clinical Response | 4 weeks posttreatment | Population analyzed was participants who had no signs or symptoms of infection at the surgical site and did not require surgical intervention for infection. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Success of Prophylaxis | Ertapenem | 90.4 | 95% Confidence Interval 86.8 to 94.1 | percentage of participants | |
| Percentage of Participants With Success of Prophylaxis | Ceftriaxone/Metronidazole | 90.3 | 95% Confidence Interval 86.6 to 94.0 | percentage of participants | |
| Percentage of Participants With Favorable Clinical Response | Ertapenem | 96.8 | 95% Confidence Interval 94.6 to 99.0 | percentage of participants | |
| Percentage of Participants With Favorable Clinical Response | Ceftriaxone/Metronidazole | 95.5 | 95% Confidence Interval 93.0 to 98.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ertapenem | 299 | |
| Overall Study | STARTED | Ceftriaxone/Metronidazole | 300 | |
| Overall Study | Treated | Ertapenem | 290 | |
| Overall Study | Treated | Ceftriaxone/Metronidazole | 297 | |
| Overall Study | COMPLETED | Ertapenem | 286 | |
| Overall Study | COMPLETED | Ceftriaxone/Metronidazole | 281 | |
| Overall Study | NOT COMPLETED | Ertapenem | 13 | |
| Overall Study | NOT COMPLETED | Ceftriaxone/Metronidazole | 19 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Ertapenem | 23 | 290 | 24 |
| other | Pyrexia | General disorders | Ceftriaxone/Metronidazole | 18 | 297 | 19 |
| serious | Cardiac Arrest | Cardiac disorders | Ertapenem | 0 | 290 | 0 |
| serious | Cardiac Arrest | Cardiac disorders | Ceftriaxone/Metronidazole | 1 | 297 | 1 |
| serious | Cardiac Failure Acute | Cardiac disorders | Ertapenem | 0 | 290 | 0 |
| serious | Cardiac Failure Acute | Cardiac disorders | Ceftriaxone/Metronidazole | 1 | 297 | 1 |
| serious | Intestinal Obstruction | Gastrointestinal disorders | Ertapenem | 1 | 290 | 1 |
| serious | Intestinal Obstruction | Gastrointestinal disorders | Ceftriaxone/Metronidazole | 0 | 297 | 0 |
| serious | Vomiting | Gastrointestinal disorders | Ertapenem | 0 | 290 | 0 |
| serious | Vomiting | Gastrointestinal disorders | Ceftriaxone/Metronidazole | 1 | 297 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ertapenem | ||
| Total, all-cause mortality | Ceftriaxone/Metronidazole | ||
| Total, other adverse events | Ertapenem | 23 | 290 |
| Total, other adverse events | Ceftriaxone/Metronidazole | 18 | 297 |
| Total, serious adverse events | Ertapenem | 6 | 290 |
| Total, serious adverse events | Ceftriaxone/Metronidazole | 14 | 297 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25151205 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ertapenem vs Ceftriaxone/Metronidazole: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01254344
GET https://conductscience.org/api/trials/v1/NCT01254344/events?page=2