Trial · NCT01844856

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

NCT01844856, Phase 3, Completed, Tetraphase Pharmaceuticals, Inc; results first posted 2016-03-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections. Trials, record NCT01844856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01844856

On this page

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 Complicated Intra-abdominal Infections
NCT number: NCT01844856
Status: Completed
Phases: Phase 3
Enrollment: 541 participants, actual
Lead sponsor: Tetraphase Pharmaceuticals, Inc
Conditions: Complicated Intra-abdominal Infections
Interventions: Eravacycline, Ertapenem, Placebo
First posted: 2013-05-01
Last updated: 2022-01-11
Results first posted: 2016-03-21

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population	TOC visit: 25-31 days after the first dose of study drug	Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
Secondary	Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit	TOC visit: 25-31 days after first dose	Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
Secondary	Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit	TOC visit: 25-31 days after first dose	Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.

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	Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population	TOC visit: 25-31 days after the first dose of study drug	All randomized participants who had baseline bacterial pathogens that cause cIAI and against at least one of which the investigational drug has in vitro antibacterial activity (micro-ITT population).	participants	NUMBER
SECONDARY	Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit	TOC visit: 25-31 days after first dose	All randomized participants who received at least 1 dose of study drug (MITT population).	participants	NUMBER
SECONDARY	Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit	TOC visit: 25-31 days after first dose	All randomized participants who had no major protocol deviations (CE population).	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	Units
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population	Eravacycline, 1.0 mg/kg q12h	Cure	191	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population	Ertapenem, 1.0 g q24h	Cure	198	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population	Eravacycline, 1.0 mg/kg q12h	Failure	19	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population	Ertapenem, 1.0 g q24h	Failure	11	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population	Eravacycline, 1.0 mg/kg q12h	Indeterminate	10	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population	Ertapenem, 1.0 g q24h	Indeterminate	17	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit	Eravacycline, 1.0 mg/kg q12h	Cure	235	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit	Ertapenem, 1.0 g q24h	Cure	238	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit	Eravacycline, 1.0 mg/kg q12h	Failure	19	participants
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit	Ertapenem, 1.0 g q24h	Failure	15	participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Eravacycline, 1.0 mg/kg q12h	270
Overall Study	STARTED	Ertapenem, 1.0 g q24h	271
Overall Study	Received at Least 1 Dose of Study Drug	Eravacycline, 1.0 mg/kg q12h	270
Overall Study	Received at Least 1 Dose of Study Drug	Ertapenem, 1.0 g q24h	268
Overall Study	COMPLETED	Eravacycline, 1.0 mg/kg q12h	246
Overall Study	COMPLETED	Ertapenem, 1.0 g q24h	255
Overall Study	NOT COMPLETED	Eravacycline, 1.0 mg/kg q12h	24
Overall Study	NOT COMPLETED	Ertapenem, 1.0 g q24h	16

Source ClinicalTrials.gov

Adverse events84

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
other	Nausea	Gastrointestinal disorders	Eravacycline, 1.0 mg/kg q12h	22	270
other	Nausea	Gastrointestinal disorders	Ertapenem, 1.0 g q24h	2	268
other	Vomiting	Gastrointestinal disorders	Eravacycline, 1.0 mg/kg q12h	11	270
other	Vomiting	Gastrointestinal disorders	Ertapenem, 1.0 g q24h	9	268
other	Anaemia	Blood and lymphatic system disorders	Eravacycline, 1.0 mg/kg q12h	7	270
other	Anaemia	Blood and lymphatic system disorders	Ertapenem, 1.0 g q24h	9	268
other	Pyrexia	General disorders	Eravacycline, 1.0 mg/kg q12h	6	270
other	Pyrexia	General disorders	Ertapenem, 1.0 g q24h	8	268
other	Phlebitis	Vascular disorders	Eravacycline, 1.0 mg/kg q12h	8	270
other	Phlebitis	Vascular disorders	Ertapenem, 1.0 g q24h	1	268

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Eravacycline, 1.0 mg/kg q12h
Total, all-cause mortality	Ertapenem, 1.0 g q24h
Total, other adverse events	Eravacycline, 1.0 mg/kg q12h	43	270
Total, other adverse events	Ertapenem, 1.0 g q24h	28	268
Total, serious adverse events	Eravacycline, 1.0 mg/kg q12h	17	270
Total, serious adverse events	Ertapenem, 1.0 g q24h	16	268

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27851857	DERIVED	PubMed
30561562	DERIVED	PubMed
31570004	DERIVED	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
Eravacycline, 1.0 mg/kg q12h vs Ertapenem, 1.0 g q24h: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01844856

GET https://conductscience.org/api/trials/v1/NCT01844856/events?page=2

API reference For AI assistants