Trial · NCT01370616
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
NCT01370616, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2014-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061). Trials, record NCT01370616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01370616
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
- NCT number
- NCT01370616
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 565 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Infection; Diabetic Foot
- Interventions
- Ertapenem sodium, Piperacillin/tazobactam sodium, Piperacillin/tazobactam-matching placebo, Amoxicillin/clavulunate potassium
- First posted
- 2011-06-10
- Last updated
- 2018-08-27
- Results first posted
- 2014-12-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV) | Day 5 up to Day 28 | The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. |
| Secondary | Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy | Day 5 | The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. |
| Secondary | Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy | Day 15 up to Day 38 | The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. |
| Secondary | Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy | Day 15 up to Day 38 | The investigator assessed participants for a favorable microbiological response, defined as eradication or presumptive eradication. Eradication means that the original pathogen was absent from the last available culture of an adequate specimen obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort. |
| Secondary | Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy | Day 15 up to Day 38 | The investigator assessed participants for both a favorable clinical response (clinical improvement or cure) and a favorable microbiological response (eradication or presumptive eradication). Clinical improvement means that most pretherapy signs and symptoms of the index infection, had resolved, and no further IV antibiotic therapy is required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. Eradication means that the original pathogen was absent from the last available culture obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort. |
| Secondary | Percentage of Participants With One or More Adverse Events (AEs) | Up to day 42 | An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the investigational product, whether or not considered related to the use of the medicinal product. This also includes any change in frequency and/or intensity of a preexisting condition which is temporally associated with the use of the medicinal product. |
| Secondary | Percentage of Participants With Drug-related AEs | Up to day 42 | A drug-related AE is any AE caused by the test drug as determined by an investigator who is a qualified physician. Drug-relatedness of the AE was assessed by evidence that the participant was actually exposed to the test drug, whether the AE followed a reasonable temporal sequence from administration of the test drug, and whether or not the AE was more reasonably explained by another source. |
| Secondary | Percentage of Participants With Serious AEs (SAEs) | Up to day 42 | A SAE is an AE occurring at any dose that resulted in any of the following: death, was life threatening, a persistent or significant disability/incapacity, prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect in an offspring, was a cancer, an overdose, or other important medical events requiring medical or surgical intervention. |
| Secondary | Percentage of Participants Who Discontinued Treatment Due to an AE | Up to day 28 | Participants chose to discontinue treatment or were discontinued from the study by the investigator due to any untoward effects, or for safety reasons such as an AE. The investigator determined whether or not the AE caused the test drug to be discontinued. |
Source ClinicalTrials.gov
Outcomes9
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 Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV) | Day 5 up to Day 28 | Participants with confirmed clinical diagnosis, adequate IV study therapy, protocol-specified visit at DCIV, and no protocol-specific exclusions. A modified last-observation-carried-forward (LOCF), where only failure was carried forward, was used to impute missing data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy | Day 5 | Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at Day 5, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy | Day 15 up to Day 38 | Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at FUA, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy | Day 15 up to Day 38 | Participants with proper clinical diagnosis, adequate study therapy, adequate clinical assessment, appropriate antimicrobial therapy, and proper microbiological assessment. A modified LOCF, where only failure was carried forward, was used to impute missing data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy | Day 15 up to Day 38 | Participants with proper clinical diagnosis, adequate study therapy and clinical assessment, appropriate antimicrobial therapy, and microbiological assessment. One participant from the Ertapenem arm with indeterminate clinical response, was excluded from the analysis. A modified LOCF (failure was carried forward), was used to impute missing data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With One or More Adverse Events (AEs) | Up to day 42 | Participants who received at least one dose of IV study therapy | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Drug-related AEs | Up to day 42 | Participants who received at least one dose of IV study therapy | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious AEs (SAEs) | Up to day 42 | Participants who received at least one dose of IV study therapy | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Discontinued Treatment Due to an AE | Up to day 28 | Participants who received at least one dose of IV study therapy | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
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 Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV) | Ertapenem Sodium | 93.6 | 95% Confidence Interval 89.5 to 96.5 | Percentage of participants | |
| Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV) | Piperacillin/Tazobactam Sodium | 97.3 | 95% Confidence Interval 94.3 to 99.0 | Percentage of participants | |
| Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy | Ertapenem Sodium | 96.2 | 95% Confidence Interval 92.6 to 98.3 | Percentage of participants | |
| Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy | Piperacillin/Tazobactam Sodium | 97.7 | 95% Confidence Interval 94.8 to 99.3 | Percentage of participants | |
| Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy | Ertapenem Sodium | 92.2 | 95% Confidence Interval 87.5 to 95.6 | Percentage of participants | |
| Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy | Piperacillin/Tazobactam Sodium | 94.4 | 95% Confidence Interval 90.1 to 97.2 | Percentage of participants | |
| Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy | Ertapenem Sodium | 86.4 | 95% Confidence Interval 79.6 to 91.6 | Percentage of participants | |
| Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy | Piperacillin/Tazobactam Sodium | 89.9 | 95% Confidence Interval 83.9 to 94.3 | Percentage of participants | |
| Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy | Ertapenem Sodium | 86.3 | 95% Confidence Interval 79.5 to 91.6 | Percentage of participants | |
| Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy | Piperacillin/Tazobactam Sodium | 89.9 | 95% Confidence Interval 83.9 to 94.3 | Percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ertapenem Sodium | 282 | |
| Overall Study | STARTED | Piperacillin/Tazobactam Sodium | 283 | |
| Overall Study | Treated | Ertapenem Sodium | 275 | |
| Overall Study | Treated | Piperacillin/Tazobactam Sodium | 275 | |
| Overall Study | COMPLETED | Ertapenem Sodium | 220 | |
| Overall Study | COMPLETED | Piperacillin/Tazobactam Sodium | 216 | |
| Overall Study | NOT COMPLETED | Ertapenem Sodium | 62 | |
| Overall Study | NOT COMPLETED | Piperacillin/Tazobactam Sodium | 67 |
Source ClinicalTrials.gov
Adverse events68
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 | Constipation | Gastrointestinal disorders | Ertapenem Sodium | 16 | 275 | 17 |
| other | Constipation | Gastrointestinal disorders | Piperacillin/Tazobactam Sodium | 14 | 275 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Ertapenem Sodium | 16 | 275 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Piperacillin/Tazobactam Sodium | 11 | 275 | 11 |
| other | Pyrexia | General disorders | Ertapenem Sodium | 21 | 275 | 27 |
| other | Pyrexia | General disorders | Piperacillin/Tazobactam Sodium | 21 | 275 | 29 |
| other | Upper respiratory tract infection | Infections and infestations | Ertapenem Sodium | 5 | 275 | 5 |
| other | Upper respiratory tract infection | Infections and infestations | Piperacillin/Tazobactam Sodium | 16 | 275 | 16 |
| other | Alanine aminotransferase increased | Investigations | Ertapenem Sodium | 35 | 275 | 36 |
| other | Alanine aminotransferase increased | Investigations | Piperacillin/Tazobactam Sodium | 19 | 275 | 19 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ertapenem Sodium | ||
| Total, all-cause mortality | Piperacillin/Tazobactam Sodium | ||
| Total, other adverse events | Ertapenem Sodium | 102 | 275 |
| Total, other adverse events | Piperacillin/Tazobactam Sodium | 89 | 275 |
| Total, serious adverse events | Ertapenem Sodium | 17 | 275 |
| Total, serious adverse events | Piperacillin/Tazobactam Sodium | 12 | 275 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26888908 | 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 Sodium vs Piperacillin/Tazobactam Sodium: 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.
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GET https://conductscience.org/api/trials/v1/NCT01370616/events?page=2