Trial · NCT03032510
Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections
NCT03032510, Phase 3, Completed, Tetraphase Pharmaceuticals, Inc; results first posted 2019-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections. Trials, record NCT03032510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03032510
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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 Ertapenem in Participants With Complicated Urinary Tract Infections
- NCT number
- NCT03032510
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,205 participants, actual
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Conditions
- Complicated Urinary Tract Infections
- Interventions
- Eravacycline, Ertapenem, Placebo, Levofloxacin
- First posted
- 2017-01-26
- Last updated
- 2022-01-06
- Results first posted
- 2019-10-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit | End of Infusion | This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate. |
| Primary | Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit | TOC visit (14-17 days after randomization) | This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate. |
| Secondary | Proportion of Participants in the ITT Population With Favorable Clinical Outcomes at TOC Visit | TOC visit (14-17 days after randomization) | Clinical cure: A complete resolution or significant improvement of signs or symptoms of the infection such that no rescue/non-study antibacterial medication was required to treat the cUTI that presented at study entry. Clinical failure: Subjects were classified as clinical failure in the event of * Death related to cUTI at any timepoint * Persistence of clinical symptoms of cUTI or new symptoms developed * Initiation of rescue/non-study antibacterial medication for cUTI Indeterminate: Study data were listed as indeterminate if the outcome was other than clinical cure or clinical failure. The reason for an indeterminate designation had to be provided Missing: Study data were listed as missing if the Investigator did not complete an assessment or if the subject did not complete the study visit. |
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 | Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit | End of Infusion | micro-ITT included all participants in the ITT population who had at least 1 baseline bacterial pathogen from a urine or blood culture that caused a urinary tract infection (UTI) against which eravacycline and ertapenem had expected antibacterial activity. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit | TOC visit (14-17 days after randomization) | micro-ITT included all participants in the ITT population who had at least 1 baseline bacterial pathogen from a urine or blood culture that caused a urinary tract infection (UTI) against which eravacycline and ertapenem had expected antibacterial activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants in the ITT Population With Favorable Clinical Outcomes at TOC Visit | TOC visit (14-17 days after randomization) | ITT included all randomized participants, regardless of receiving study drug or not. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit | Eravacycline (Intravenous) | Responder | 363 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit | Ertapenem (Intravenous) | Responder | 382 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit | Eravacycline (Intravenous) | Non-responder | 51 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit | Ertapenem (Intravenous) | Non-responder | 7 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit | Eravacycline (Intravenous) | Indeterminate | 14 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit | Ertapenem (Intravenous) | Indeterminate | 14 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit | Eravacycline | Responder | 293 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit | Ertapenem | Responder | 302 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit | Eravacycline | Non-responder | 116 | Participants | |
| Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit | Ertapenem | Non-responder | 86 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eravacycline (Intravenous)/Levofloxacin (Oral) | 603 | |
| Overall Study | STARTED | Ertapenem (Intravenous)/Levofloxacin (Oral) | 602 | |
| Overall Study | COMPLETED | Eravacycline (Intravenous)/Levofloxacin (Oral) | 576 | |
| Overall Study | COMPLETED | Ertapenem (Intravenous)/Levofloxacin (Oral) | 584 | |
| Overall Study | NOT COMPLETED | Eravacycline (Intravenous)/Levofloxacin (Oral) | 27 | |
| Overall Study | NOT COMPLETED | Ertapenem (Intravenous)/Levofloxacin (Oral) | 18 |
Source ClinicalTrials.gov
Adverse events48
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 (Intravenous) | 84 | 601 | |
| other | Nausea | Gastrointestinal disorders | Ertapenem (Intravenous) | 10 | 600 | |
| other | Vomiting | Gastrointestinal disorders | Eravacycline (Intravenous) | 31 | 601 | |
| other | Vomiting | Gastrointestinal disorders | Ertapenem (Intravenous) | 4 | 600 | |
| other | Infusion site phlebitis | General disorders | Eravacycline (Intravenous) | 24 | 601 | |
| other | Infusion site phlebitis | General disorders | Ertapenem (Intravenous) | 3 | 600 | |
| other | Diarrhoea | Gastrointestinal disorders | Eravacycline (Intravenous) | 18 | 601 | |
| other | Diarrhoea | Gastrointestinal disorders | Ertapenem (Intravenous) | 17 | 600 | |
| other | Headache | General disorders | Eravacycline (Intravenous) | 17 | 601 | |
| other | Headache | General disorders | Ertapenem (Intravenous) | 18 | 600 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eravacycline (Intravenous) | 3 | 601 |
| Total, all-cause mortality | Ertapenem (Intravenous) | 2 | 600 |
| Total, other adverse events | Eravacycline (Intravenous) | 174 | 601 |
| Total, other adverse events | Ertapenem (Intravenous) | 52 | 600 |
| Total, serious adverse events | Eravacycline (Intravenous) | 11 | 601 |
| Total, serious adverse events | Ertapenem (Intravenous) | 6 | 600 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 (Intravenous) vs Ertapenem (Intravenous): deaths from any cause | Trial comparisons |
| Eravacycline (Intravenous) vs Ertapenem (Intravenous): 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/NCT03032510
GET https://conductscience.org/api/trials/v1/NCT03032510/events?page=2