Trial · NCT03357614
Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults
NCT03357614, Phase 3, Completed, Iterum Therapeutics, International Limited; results first posted 2020-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults. Trials, record NCT03357614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03357614
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults
- NCT number
- NCT03357614
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,395 participants, actual
- Lead sponsor
- Iterum Therapeutics, International Limited
- Conditions
- Complicated Urinary Tract Infections
- Interventions
- Sulopenem, Sulopenem-Etzadroxil/Probenecid, Ertapenem, Ciprofloxacin, Amoxicillin-clavulanate
- First posted
- 2017-11-30
- Last updated
- 2020-12-29
- Results first posted
- 2020-12-29
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 Overall Success | Day 21 +/- 1 day | Clinical success is defined as complete resolution of cUTI symptoms present at study entry and no new cUTI symptoms; microbiologic success is defined as eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL) |
| Secondary | Percentage of Participants With Microbiologic Success | Day 21 +/- 1 day | Microbiologic success is defined as demonstrating \<1000 CFU/mL of the baseline urpathogen by quantitative urine culture |
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 Overall Success | Day 21 +/- 1 day | Analysis population is the microbiologic modified intent-to-treat population (all modified intent-to-treat patients with a positive study entry urine culture within 48 hours prior to first dose, defined as \>100,000 CFU/mL of a uropathogen and no more than 2 species of a uropathogen \>100,000 CFU/mL; if 1 of the uropathogens was also isolated from baseline blood culture, however, the patient was included in this population regardless of the baseline urine culture result). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Microbiologic Success | Day 21 +/- 1 day | Analysis population is the microbiologic modified intent-to-treat population (all modified intent-to-treat patients with a positive study entry urine culture within 48 hours prior to first dose, defined as \>100,000 CFU/mL of a uropathogen and no more than 2 species of a uropathogen \>100,000 CFU/mL; if 1 of the uropathogens was also isolated from baseline blood culture, however, the patient was included in this population regardless of the baseline urine culture result). | 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 Overall Success | Sulopenem | 301 | Participants | ||
| Percentage of Participants With Overall Success | Ertapenem | 325 | Participants | ||
| Percentage of Participants With Microbiologic Success | Sulopenem | 316 | Participants | ||
| Percentage of Participants With Microbiologic Success | Ertapenem | 343 | 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 | 697 | |
| Overall Study | STARTED | Ertapenem | 698 | |
| Overall Study | COMPLETED | Sulopenem | 672 | |
| Overall Study | COMPLETED | Ertapenem | 670 | |
| Overall Study | NOT COMPLETED | Sulopenem | 25 | |
| Overall Study | NOT COMPLETED | Ertapenem | 28 |
Source ClinicalTrials.gov
Adverse events32
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 | Cardiac failure | Cardiac disorders | Sulopenem | 1 | 697 | 1 |
| serious | Cardiac failure | Cardiac disorders | Ertapenem | 0 | 698 | 0 |
| serious | Cardiac failure congestive | Cardiac disorders | Sulopenem | 1 | 697 | 1 |
| serious | Cardiac failure congestive | Cardiac disorders | Ertapenem | 0 | 698 | 0 |
| serious | Atrioventricular block complete | Cardiac disorders | Sulopenem | 0 | 697 | 0 |
| serious | Atrioventricular block complete | Cardiac disorders | Ertapenem | 1 | 698 | 1 |
| serious | Abscess neck | Infections and infestations | Sulopenem | 0 | 697 | 0 |
| serious | Abscess neck | Infections and infestations | Ertapenem | 1 | 698 | 1 |
| serious | Cystitis | Infections and infestations | Sulopenem | 0 | 697 | 0 |
| serious | Cystitis | Infections and infestations | Ertapenem | 1 | 698 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sulopenem | 2 | 697 |
| Total, all-cause mortality | Ertapenem | 0 | 698 |
| Total, other adverse events | Sulopenem | 0 | 697 |
| Total, other adverse events | Ertapenem | 0 | 698 |
| Total, serious adverse events | Sulopenem | 14 | 697 |
| Total, serious adverse events | Ertapenem | 6 | 698 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36068705 | DERIVED |
Source 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sulopenem vs Ertapenem: Percentage of Participants With Overall Success | Trial comparisons |
| Sulopenem vs Ertapenem: Percentage of Participants With Microbiologic 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/NCT03357614
GET https://conductscience.org/api/trials/v1/NCT03357614/events?page=2