Trial · NCT02784704
Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
NCT02784704, Phase 3, Completed, Tetraphase Pharmaceuticals, Inc; results first posted 2019-02-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections. Trials, record NCT02784704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02784704
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
- NCT number
- NCT02784704
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 500 participants, actual
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Conditions
- Complicated Intra-abdominal Infections, Complicated Appendicitis
- Interventions
- Eravacycline, Meropenem, Placebo
- First posted
- 2016-05-27
- Last updated
- 2022-01-06
- Results first posted
- 2019-02-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population | TOC visit: 25-31 days after first dose of study drug | Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI. |
| Secondary | Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population | TOC visit: 25-31 days after first dose of study drug | Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI. |
| Secondary | Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population | TOC visit: 25-31 days after first dose of study drug | Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population | TOC visit: 25-31 days after first dose of study drug | Microbiological Intent-to-Treat Population: all randomized subjects who have at least one baseline bacterial pathogen that causes cIAI and against which the investigational drug has in vitro antibacterial activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population | TOC visit: 25-31 days after first dose of study drug | Modified Intent-to-Treat Population: all randomized subjects who receive any amount of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population | TOC visit: 25-31 days after first dose of study drug | Clinically Evaluable: all randomized subjects who meet key inclusion/exclusion criteria and follow other important components of the trial | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population | Eravacycline | Clinical Cure | 177 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population | Meropenem | Clinical Cure | 187 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population | Eravacycline | Clinical Failure | 7 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population | Meropenem | Clinical Failure | 7 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population | Eravacycline | Indeterminate/missing | 11 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population | Meropenem | Indeterminate/missing | 11 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population | Eravacycline | Clinical Cure | 231 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population | Meropenem | Clinical Cure | 228 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population | Eravacycline | Clinical Failure | 7 | Participants | |
| Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population | Meropenem | Clinical Failure | 9 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eravacycline | 250 | |
| Overall Study | STARTED | Meropenem | 250 | |
| Overall Study | Treated | Eravacycline | 250 | |
| Overall Study | Treated | Meropenem | 249 | |
| Overall Study | COMPLETED | Eravacycline | 237 | |
| Overall Study | COMPLETED | Meropenem | 241 | |
| Overall Study | NOT COMPLETED | Eravacycline | 13 | |
| Overall Study | NOT COMPLETED | Meropenem | 9 |
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 | Eravacycline | 12 | 250 | |
| other | Nausea | Gastrointestinal disorders | Meropenem | 2 | 249 | |
| other | Vomiting | Gastrointestinal disorders | Eravacycline | 9 | 250 | |
| other | Vomiting | Gastrointestinal disorders | Meropenem | 5 | 249 | |
| other | Infusion site phlebitis | General disorders | Eravacycline | 8 | 250 | |
| other | Infusion site phlebitis | General disorders | Meropenem | 1 | 249 | |
| serious | Pneumonia | Infections and infestations | Eravacycline | 2 | 250 | |
| serious | Pneumonia | Infections and infestations | Meropenem | 1 | 249 | |
| serious | Abdominal wound dehiscence | Injury, poisoning and procedural complications | Eravacycline | 1 | 250 | |
| serious | Abdominal wound dehiscence | Injury, poisoning and procedural complications | Meropenem | 0 | 249 |
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 | Eravacycline | 4 | 250 |
| Total, all-cause mortality | Meropenem | 1 | 249 |
| Total, other adverse events | Eravacycline | 29 | 250 |
| Total, other adverse events | Meropenem | 8 | 249 |
| Total, serious adverse events | Eravacycline | 15 | 250 |
| Total, serious adverse events | Meropenem | 16 | 249 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eravacycline vs Meropenem: deaths from any cause | Trial comparisons |
| Eravacycline vs Meropenem: serious adverse events | 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/NCT02784704
GET https://conductscience.org/api/trials/v1/NCT02784704/events?page=2