Trial · NCT05584657
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
NCT05584657, Phase 3, Completed, Iterum Therapeutics, International Limited; results first posted 2024-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women. Trials, record NCT05584657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05584657
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
- NCT number
- NCT05584657
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,229 participants, actual
- Lead sponsor
- Iterum Therapeutics, International Limited
- Conditions
- Urinary Tract Infections, Cystitis
- Interventions
- Sulopenem etzadroxil/probenecid, Amoxicillin/clavulanate
- First posted
- 2022-10-18
- Last updated
- 2024-11-20
- Results first posted
- 2024-11-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Success | Day 12+/-1 day | Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen) |
| Primary | Overall Success Susceptible Population | Day 12+/-1 day | Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen) |
| Secondary | Clinical Success Modified Intent-to-treat Population | Day 12+/-1 day | Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms |
| Secondary | Clinical Success | Day 12+/-1 day | Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms |
| Secondary | Clinical Success Susceptible Population | Day 12+/-1 day | Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms |
| Secondary | Microbiologic Success | Day 12+/-1 day | Eradication of the Baseline Pathogen |
| Secondary | Microbiologic Success Susceptible Population | Day 12+/-1 day | Microbiologic Success: Eradication of the Baseline Pathogen |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Success | Day 12+/-1 day | Microbiologic Modified Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Success Susceptible Population | Day 12+/-1 day | Microbiological Modified intent-to-treat Susceptible Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Success Modified Intent-to-treat Population | Day 12+/-1 day | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Success | Day 12+/-1 day | Microbiological Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Success Susceptible Population | Day 12+/-1 day | Microbiological Modified Intent-to-treat Susceptible Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Microbiologic Success | Day 12+/-1 day | Microbiological Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Microbiologic Success Susceptible Population | Day 12+/-1 day | Microbiological Modified Intent-to-treat Susceptible Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Success | Sulopenem Etzadroxil/Probenecid | 318 | Participants | ||
| Overall Success | Amoxicillin/Clavulanate | 260 | Participants | ||
| Overall Success Susceptible Population | Sulopenem Etzadroxil/Probenecid | 296 | Participants | ||
| Overall Success Susceptible Population | Amoxicillin/Clavulanate | 243 | Participants | ||
| Clinical Success Modified Intent-to-treat Population | Sulopenem Etzadroxil/Probenecid | 851 | Participants | ||
| Clinical Success Modified Intent-to-treat Population | Amoxicillin/Clavulanate | 849 | Participants | ||
| Clinical Success | Sulopenem Etzadroxil/Probenecid | 397 | Participants | ||
| Clinical Success | Amoxicillin/Clavulanate | 358 | Participants | ||
| Clinical Success Susceptible Population | Sulopenem Etzadroxil/Probenecid | 371 | Participants | ||
| Clinical Success Susceptible Population | Amoxicillin/Clavulanate | 339 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sulopenem Etzadroxil/Probenecid | 1,111 | |
| Overall Study | STARTED | Amoxicillin/Clavulanate | 1,111 | |
| Overall Study | COMPLETED | Sulopenem Etzadroxil/Probenecid | 1,057 | |
| Overall Study | COMPLETED | Amoxicillin/Clavulanate | 1,063 | |
| Overall Study | NOT COMPLETED | Sulopenem Etzadroxil/Probenecid | 54 | |
| Overall Study | NOT COMPLETED | Amoxicillin/Clavulanate | 48 |
Source ClinicalTrials.gov
Adverse events20
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 | Diarrhea | Gastrointestinal disorders | Sulopenem Etzadroxil/Probenecid | 90 | 1,107 | 90 |
| other | Diarrhea | Gastrointestinal disorders | Amoxicillin/Clavulanate | 45 | 1,107 | 45 |
| other | Nausea | Gastrointestinal disorders | Sulopenem Etzadroxil/Probenecid | 48 | 1,107 | 48 |
| other | Nausea | Gastrointestinal disorders | Amoxicillin/Clavulanate | 48 | 1,107 | 48 |
| other | Headache | Nervous system disorders | Sulopenem Etzadroxil/Probenecid | 24 | 1,107 | 24 |
| other | Headache | Nervous system disorders | Amoxicillin/Clavulanate | 17 | 1,107 | 17 |
| other | Vulvovaginal mycotic infection | Infections and infestations | Sulopenem Etzadroxil/Probenecid | 20 | 1,107 | 20 |
| other | Vulvovaginal mycotic infection | Infections and infestations | Amoxicillin/Clavulanate | 4 | 1,107 | 4 |
| other | Vomiting | Gastrointestinal disorders | Sulopenem Etzadroxil/Probenecid | 16 | 1,107 | 16 |
| other | Vomiting | Gastrointestinal disorders | Amoxicillin/Clavulanate | 4 | 1,107 | 4 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sulopenem Etzadroxil/Probenecid | 0 | 1,107 |
| Total, all-cause mortality | Amoxicillin/Clavulanate | 0 | 1,107 |
| Total, other adverse events | Sulopenem Etzadroxil/Probenecid | 198 | 1,107 |
| Total, other adverse events | Amoxicillin/Clavulanate | 118 | 1,107 |
| Total, serious adverse events | Sulopenem Etzadroxil/Probenecid | 0 | 1,107 |
| Total, serious adverse events | Amoxicillin/Clavulanate | 5 | 1,107 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40552968 | 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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: Clinical Success Modified Intent-to-treat Population | Trial comparisons |
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: Microbiologic Success | Trial comparisons |
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: Microbiologic Success Susceptible Population | Trial comparisons |
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: Overall Success | Trial comparisons |
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: Clinical Success Susceptible Population | Trial comparisons |
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: Clinical Success | Trial comparisons |
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: deaths from any cause | Trial comparisons |
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: Overall Success Susceptible Population | Trial comparisons |
| Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: 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/NCT05584657
GET https://conductscience.org/api/trials/v1/NCT05584657/registered