Trial · NCT03358576
Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
NCT03358576, Phase 3, Completed, Iterum Therapeutics, International Limited; results first posted 2020-12-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI). Trials, record NCT03358576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03358576
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
- NCT number
- NCT03358576
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 674 participants, actual
- Lead sponsor
- Iterum Therapeutics, International Limited
- Conditions
- Intra Abdominal Infections
- Interventions
- Ertapenem, Sulopenem-Etzadroxil/Probenecid, Ciprofloxacin, Metronidazole, Amoxicillin-Clavulanate, Sulopenem
- First posted
- 2017-11-30
- Last updated
- 2020-12-01
- Results first posted
- 2020-12-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Success | Day 28 +/- 1 day | Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions |
| Secondary | Percentage of Participants With Clinical Success | Day 11-14 +/- 1 day | Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions |
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 | Percentage of Participants With Clinical Success | Day 28 +/- 1 day | micro-MITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Success | Day 11-14 +/- 1 day | micro-MITT population | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Success | Sulopenem | 85.5 | percentage of participants | ||
| Percentage of Participants With Clinical Success | Ertapenem | 90.2 | percentage of participants | ||
| Percentage of Participants With Clinical Success | Sulopenem | 208 | Participants | ||
| Percentage of Participants With Clinical Success | Ertapenem | 227 | Participants |
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 | Sulopenem | 338 | |
| Overall Study | STARTED | Ertapenem | 336 | |
| Overall Study | COMPLETED | Sulopenem | 312 | |
| Overall Study | COMPLETED | Ertapenem | 311 | |
| Overall Study | NOT COMPLETED | Sulopenem | 26 | |
| Overall Study | NOT COMPLETED | Ertapenem | 25 |
Source ClinicalTrials.gov
Adverse events64
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 |
|---|---|---|---|---|---|---|
| serious | Abdominal abscess | Infections and infestations | Sulopenem | 6 | 338 | 6 |
| serious | Abdominal abscess | Infections and infestations | Ertapenem | 0 | 336 | 0 |
| serious | cardiac arrest | Cardiac disorders | Sulopenem | 1 | 338 | 1 |
| serious | cardiac arrest | Cardiac disorders | Ertapenem | 0 | 336 | 0 |
| serious | ventricular fibrillation | Cardiac disorders | Sulopenem | 1 | 338 | 1 |
| serious | ventricular fibrillation | Cardiac disorders | Ertapenem | 0 | 336 | 0 |
| serious | Angina unstable | Cardiac disorders | Sulopenem | 0 | 338 | 0 |
| serious | Angina unstable | Cardiac disorders | Ertapenem | 1 | 336 | 1 |
| serious | cardiac failure acute | Cardiac disorders | Sulopenem | 0 | 338 | 0 |
| serious | cardiac failure acute | Cardiac disorders | Ertapenem | 1 | 336 | 1 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sulopenem | 4 | 338 |
| Total, all-cause mortality | Ertapenem | 4 | 336 |
| Total, other adverse events | Sulopenem | 0 | 335 |
| Total, other adverse events | Ertapenem | 0 | 333 |
| Total, serious adverse events | Sulopenem | 25 | 338 |
| Total, serious adverse events | Ertapenem | 12 | 336 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sulopenem vs Ertapenem: Percentage of Participants With Clinical Success | Trial comparisons |
| Sulopenem vs Ertapenem: deaths from any cause | Trial comparisons |
| Sulopenem vs Ertapenem: 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/NCT03358576
GET https://conductscience.org/api/trials/v1/NCT03358576/events?page=2