Trial · NCT01147640
Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections
NCT01147640, Phase 2, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2015-01-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections. Trials, record NCT01147640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01147640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections
- NCT number
- NCT01147640
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Complicated Intra-abdominal Infection
- Interventions
- CXA-101/ tazobactam and metronidazole, meropenem plus saline placebo
- First posted
- 2010-06-22
- Last updated
- 2018-10-25
- Results first posted
- 2015-01-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population | Test-of-Cure Visit (7-14 days after End of Therapy [EOT]) | Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection. |
| Secondary | Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population | Test-of-Cure Visit (7-14 days after EOT) | Microbiological response is eradication (absence of the baseline pathogen from a suitable intra-abdominal specimen) or presumed eradication (absence of a suitable intra-abdominal specimen to culture at the TOC visit in a subject who is assessed as a clinical cure at TOC) |
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 | Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population | Test-of-Cure Visit (7-14 days after End of Therapy [EOT]) | mMITT: Treated subjects, with baseline pathogen | percentage of subjects | NUMBER |
| SECONDARY | Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population | Test-of-Cure Visit (7-14 days after EOT) | Microbiologically Evaluable: treated subjects, with baseline pathogen susceptible to study drug, complied with protocol | percentage of subjects | 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 |
|---|---|---|---|---|---|
| Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population | CXA 101/Tazobactam and Metronidazole | 83.6 | 95% Confidence Interval 71.9 to 91.8 | percentage of subjects | |
| Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population | Meropenem With Matching Saline Placebo | 96.0 | 95% Confidence Interval 79.6 to 99.9 | percentage of subjects | |
| Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population | CXA 101/Tazobactam and Metronidazole | 90.6 | 95% Confidence Interval 79.3 to 96.9 | percentage of subjects | |
| Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population | Meropenem With Matching Saline Placebo | 95.8 | 95% Confidence Interval 78.9 to 99.9 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CXA 101/Tazobactam and Metronidazole | 83 | |
| Overall Study | STARTED | Meropenem With Matching Saline Placebo | 39 | |
| Overall Study | COMPLETED | CXA 101/Tazobactam and Metronidazole | 78 | |
| Overall Study | COMPLETED | Meropenem With Matching Saline Placebo | 38 | |
| Overall Study | NOT COMPLETED | CXA 101/Tazobactam and Metronidazole | 5 | |
| Overall Study | NOT COMPLETED | Meropenem With Matching Saline Placebo | 1 |
Source ClinicalTrials.gov
Adverse events74
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 | Nausea | Gastrointestinal disorders | CXA 101/Tazobactam and Metronidazole | 5 | 82 | |
| other | Nausea | Gastrointestinal disorders | Meropenem With Matching Saline Placebo | 4 | 39 | |
| other | Vomiting | Gastrointestinal disorders | CXA 101/Tazobactam and Metronidazole | 4 | 82 | |
| other | Vomiting | Gastrointestinal disorders | Meropenem With Matching Saline Placebo | 3 | 39 | |
| other | Diarrhoea | Gastrointestinal disorders | CXA 101/Tazobactam and Metronidazole | 4 | 82 | |
| other | Diarrhoea | Gastrointestinal disorders | Meropenem With Matching Saline Placebo | 3 | 39 | |
| other | Ileus | Gastrointestinal disorders | CXA 101/Tazobactam and Metronidazole | 3 | 82 | |
| other | Ileus | Gastrointestinal disorders | Meropenem With Matching Saline Placebo | 0 | 39 | |
| other | Pyrexia | General disorders | CXA 101/Tazobactam and Metronidazole | 12 | 82 | |
| other | Pyrexia | General disorders | Meropenem With Matching Saline Placebo | 4 | 39 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CXA 101/Tazobactam and Metronidazole | ||
| Total, all-cause mortality | Meropenem With Matching Saline Placebo | ||
| Total, other adverse events | CXA 101/Tazobactam and Metronidazole | 30 | 82 |
| Total, other adverse events | Meropenem With Matching Saline Placebo | 12 | 39 |
| Total, serious adverse events | CXA 101/Tazobactam and Metronidazole | 14 | 82 |
| Total, serious adverse events | Meropenem With Matching Saline Placebo | 2 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24982069 | DERIVED |
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 |
|---|
| CXA 101/Tazobactam and Metronidazole vs Meropenem With Matching Saline Placebo: 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/NCT01147640
GET https://conductscience.org/api/trials/v1/NCT01147640/events?page=2