Trial · NCT03354598
Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
NCT03354598, Phase 3, Completed, Iterum Therapeutics, International Limited; results first posted 2020-12-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women. Trials, record NCT03354598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03354598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
- NCT number
- NCT03354598
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,671 participants, actual
- Lead sponsor
- Iterum Therapeutics, International Limited
- Conditions
- Uncomplicated Urinary Tract Infections
- Interventions
- Sulopenem-Etzadroxil/Probenecid, Ciprofloxacin
- First posted
- 2017-11-28
- Last updated
- 2021-01-12
- Results first posted
- 2020-12-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success | Day 12+/-1 day | Overall Success: 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 | Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success | Day 12 +/- 1 day | Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen) |
| Secondary | Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success | Day 12+/-1 day | Microbiologic success is defined as eradication of the baseline pathogen (\<1000 Colony Forming Units (CFU)/mL) at the Test of Cure visit |
| Other | Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Overall Success | 12 +/- 1 day | Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success | Day 12+/-1 day | micro-MITTR population: patients with baseline uropathogen non-susceptible to the comparator ciprofloxacin. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success | Day 12 +/- 1 day | micro-MITTS population: patients with baseline uropathogen susceptible to the comparator ciprofloxacin. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success | Day 12+/-1 day | micro-MITTR population: patients with baseline uropathogen non-susceptible to the comparator ciprofloxacin. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Overall Success | 12 +/- 1 day | micro-MITT population: micro-MITTR and micro-MITTS (ciprofloxacin nonsusceptible and ciprofloxacin susceptible) populations combined. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success | Sulopenem-etzadroxil/Probenecid | 62.6 | percentage of participants | ||
| Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success | Ciprofloxacin | 36.0 | percentage of participants | ||
| Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success | Sulopenem-etzadroxil/Probenecid | 66.8 | percentage of participants | ||
| Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success | Ciprofloxacin | 78.6 | percentage of participants | ||
| Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success | Sulopenem-etzadroxil/Probenecid | 74.1 | percentage of participants | ||
| Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success | Ciprofloxacin | 49.6 | percentage of participants | ||
| Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Overall Success | Sulopenem-etzadroxil/Probenecid | 65.6 | percentage of participants | ||
| Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Overall Success | Ciprofloxacin | 67.9 | percentage of participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sulopenem-etzadroxil/Probenecid | 835 | |
| Overall Study | STARTED | Ciprofloxacin | 836 | |
| Overall Study | Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants | Sulopenem-etzadroxil/Probenecid | 147 | |
| Overall Study | Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants | Ciprofloxacin | 139 | |
| Overall Study | Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants | Sulopenem-etzadroxil/Probenecid | 370 | |
| Overall Study | Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants | Ciprofloxacin | 415 | |
| Overall Study | Microbiologic Modified Intent to Treat (Micro-MITT) Participants | Sulopenem-etzadroxil/Probenecid | 517 | |
| Overall Study | Microbiologic Modified Intent to Treat (Micro-MITT) Participants | Ciprofloxacin | 554 | |
| Overall Study | Modified Intent to Treat (MITT) Participants | Sulopenem-etzadroxil/Probenecid | 785 | |
| Overall Study | Modified Intent to Treat (MITT) Participants | Ciprofloxacin | 794 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events24
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 | 103 | 833 | 947 |
| other | Diarrhea | Gastrointestinal disorders | Ciprofloxacin | 21 | 827 | 91 |
| serious | Diarrhoea | Gastrointestinal disorders | Sulopenem-etzadroxil/Probenecid | 0 | 833 | 0 |
| serious | Diarrhoea | Gastrointestinal disorders | Ciprofloxacin | 1 | 827 | 1 |
| serious | Abdominal pain upper | Gastrointestinal disorders | Sulopenem-etzadroxil/Probenecid | 1 | 833 | 1 |
| serious | Abdominal pain upper | Gastrointestinal disorders | Ciprofloxacin | 0 | 827 | 0 |
| serious | small intestine obstruction | Gastrointestinal disorders | Sulopenem-etzadroxil/Probenecid | 1 | 833 | 1 |
| serious | small intestine obstruction | Gastrointestinal disorders | Ciprofloxacin | 0 | 827 | 0 |
| serious | chest pain | General disorders | Sulopenem-etzadroxil/Probenecid | 1 | 833 | 1 |
| serious | chest pain | General disorders | Ciprofloxacin | 0 | 827 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sulopenem-etzadroxil/Probenecid | 1 | 833 |
| Total, all-cause mortality | Ciprofloxacin | 0 | 827 |
| Total, other adverse events | Sulopenem-etzadroxil/Probenecid | 103 | 833 |
| Total, other adverse events | Ciprofloxacin | 21 | 827 |
| Total, serious adverse events | Sulopenem-etzadroxil/Probenecid | 6 | 833 |
| Total, serious adverse events | Ciprofloxacin | 2 | 827 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36069202 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin: deaths from any cause | Trial comparisons |
| Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin: 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/NCT03354598
GET https://conductscience.org/api/trials/v1/NCT03354598/events?page=2