Trial · NCT01445678
Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections
NCT01445678, Phase 3, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2015-01-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections. Trials, record NCT01445678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01445678
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections
- NCT number
- NCT01445678
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 494 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Complicated Intra-abdominal Infection
- Interventions
- CXA-201 and metronidazole, Meropenem
- First posted
- 2011-10-04
- Last updated
- 2018-11-16
- Results first posted
- 2015-01-15
- Limitations and caveats
Two identical P3 protocols were initiated (NCT01445678 and NCT01445665) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. These analyses are presented here.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | TOC; 26-30 days after start of study drug administration | Clinical cure is complete resolution or significant improvement in 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 | The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population | TOC; 26-30 days after start of study drug administration | Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure) for each baseline pathogen |
| Secondary | The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population | EOT; Within 24 hours of last study drug administration | Clinical response is complete resolution or significant improvement in 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 | The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population | EOT; Within 24 hours of last study drug administration | Clinical response is complete resolution or significant improvement in 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 | The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population | LFU; 38 to 45 days after first study drug administration | Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit. |
| Secondary | The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population | LFU; 38 to 45 days after first study drug administration | Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | TOC; 26-30 days after start of study drug administration | MITT: Randomized patients, with baseline pathogen. | percentage of subjects | NUMBER |
| SECONDARY | The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population | TOC; 26-30 days after start of study drug administration | Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug. | percentage of subjects | NUMBER |
| SECONDARY | The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population | EOT; Within 24 hours of last study drug administration | MITT: Microbiological Intent-to-Treat: Randomized patients, with baseline pathogen. | percentage of subjects | NUMBER |
| SECONDARY | The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population | EOT; Within 24 hours of last study drug administration | Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug. | percentage of subjects | NUMBER |
| SECONDARY | The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population | LFU; 38 to 45 days after first study drug administration | MITT: Randomized patients, with baseline pathogen. | percentage of subjects | NUMBER |
| SECONDARY | The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population | LFU; 38 to 45 days after first study drug administration | Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | CXA-201 and Metronidazole as Treatment for cIAI | 83.0 | percentage of subjects | ||
| The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | Meropenem as Treatment for cIAI | 87.3 | percentage of subjects | ||
| The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population | CXA-201 and Metronidazole as Treatment for cIAI | 94.2 | percentage of subjects | ||
| The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population | Meropenem as Treatment for cIAI | 94.7 | percentage of subjects | ||
| The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population | CXA-201 and Metronidazole as Treatment for cIAI | 89.2 | percentage of subjects | ||
| The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population | Meropenem as Treatment for cIAI | 92.3 | percentage of subjects | ||
| The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population | CXA-201 and Metronidazole as Treatment for cIAI | 97.1 | percentage of subjects | ||
| The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population | Meropenem as Treatment for cIAI | 97.5 | percentage of subjects | ||
| The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population | CXA-201 and Metronidazole as Treatment for cIAI | 82.5 | percentage of subjects | ||
| The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population | Meropenem as Treatment for cIAI | 86.6 | percentage of subjects |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CXA-201 and Metronidazole as Treatment for cIAI | 482 | |
| Overall Study | STARTED | Meropenem as Treatment for cIAI | 497 | |
| Overall Study | COMPLETED | CXA-201 and Metronidazole as Treatment for cIAI | 452 | |
| Overall Study | COMPLETED | Meropenem as Treatment for cIAI | 476 | |
| Overall Study | NOT COMPLETED | CXA-201 and Metronidazole as Treatment for cIAI | 30 | |
| Overall Study | NOT COMPLETED | Meropenem as Treatment for cIAI | 21 |
Source ClinicalTrials.gov
Adverse events232
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 | Anaemia | Blood and lymphatic system disorders | CXA-201 and Metronidazole as Treatment for cIAI | 6 | 482 | |
| other | Anaemia | Blood and lymphatic system disorders | Meropenem as Treatment for cIAI | 4 | 497 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | CXA-201 and Metronidazole as Treatment for cIAI | 8 | 482 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Meropenem as Treatment for cIAI | 5 | 497 | |
| other | Atrial fibrillation | Cardiac disorders | CXA-201 and Metronidazole as Treatment for cIAI | 6 | 482 | |
| other | Atrial fibrillation | Cardiac disorders | Meropenem as Treatment for cIAI | 2 | 497 | |
| other | Tachycardia | Cardiac disorders | CXA-201 and Metronidazole as Treatment for cIAI | 7 | 482 | |
| other | Tachycardia | Cardiac disorders | Meropenem as Treatment for cIAI | 9 | 497 | |
| other | Abdominal pain | Gastrointestinal disorders | CXA-201 and Metronidazole as Treatment for cIAI | 6 | 482 | |
| other | Abdominal pain | Gastrointestinal disorders | Meropenem as Treatment for cIAI | 2 | 497 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CXA-201 and Metronidazole as Treatment for cIAI | ||
| Total, all-cause mortality | Meropenem as Treatment for cIAI | ||
| Total, other adverse events | CXA-201 and Metronidazole as Treatment for cIAI | 159 | 482 |
| Total, other adverse events | Meropenem as Treatment for cIAI | 138 | 497 |
| Total, serious adverse events | CXA-201 and Metronidazole as Treatment for cIAI | 39 | 482 |
| Total, serious adverse events | Meropenem as Treatment for cIAI | 36 | 497 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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-201 and Metronidazole as Treatment for cIAI vs Meropenem as Treatment for cIAI: 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/NCT01445678
GET https://conductscience.org/api/trials/v1/NCT01445678/events?page=2