A Phase 3 interventional study of Sulopenem etzadroxil/probenecid and Amoxicillin/clavulanate in Urinary Tract Infections and Cystitis, sponsored by Iterum Therapeutics, International Limited. Completed at 167 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Iterum Therapeutics, International Limited · Phase 3, Interventional, and Treatment
Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 2,229 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Iterum Therapeutics, International Limited is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Drug: Sulopenem etzadroxil/probenecid
Amoxicillin/clavulanate PO twice daily for 5 days
Drug: Amoxicillin/clavulanate
Drug pages: Sulopenem etzadroxil · Probenecid
Oral sulopenem twice daily for 5 days
Also known as: Oral sulopenem
Drug pages: Amoxicillin · Clavulanic Acid
Oral Augmentin twice daily for 5 days
Also known as: Augmentin
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)
Time frame: Day 12+/-1 day
Overall Success Susceptible Population
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)
Time frame: Day 12+/-1 day
Clinical Success Modified Intent-to-treat Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time frame: Day 12+/-1 day
Clinical Success
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time frame: Day 12+/-1 day
Clinical Success Susceptible Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Time frame: Day 12+/-1 day
Microbiologic Success
Eradication of the Baseline Pathogen
Time frame: Day 12+/-1 day
Microbiologic Success Susceptible Population
Microbiologic Success: Eradication of the Baseline Pathogen
Time frame: Day 12+/-1 day
| Milestone | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| Started | 1111 | 1111 |
| Completed | 1057 | 1063 |
| Not completed | 54 | 48 |
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)
| Participants | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| Overall Success | 318 | 260 |
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)
| Participants | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| Overall Success Susceptible Population | 296 | 243 |
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
| Participants | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| Clinical Success Modified Intent-to-treat Population | 851 | 849 |
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
| Participants | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| Clinical Success | 397 | 358 |
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
| Participants | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| Clinical Success Susceptible Population | 371 | 339 |
Eradication of the Baseline Pathogen
| Participants | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| Microbiologic Success | 390 | 315 |
Microbiologic Success: Eradication of the Baseline Pathogen
| Participants | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| Microbiologic Success Susceptible Population | 361 | 295 |
Collected over 28 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sulopenem Etzadroxil/Probenecid | 0/1,107 (0%) | 0/1,107 (0%) | 198/1,107 (17.9%) |
| Amoxicillin/Clavulanate | 0/1,107 (0%) | 5/1,107 (0.5%) | 118/1,107 (10.7%) |
| Event | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| DehydrationMetabolism and nutrition disorders | 0/1107 | 1/1107 |
| UreterolithiasisRenal and urinary disorders | 0/1107 | 1/1107 |
| Genital herpesInfections and infestations | 0/1107 | 1/1107 |
| DiverticulumGastrointestinal disorders | 0/1107 | 1/1107 |
| Chest painGeneral disorders | 0/1107 | 1/1107 |
| Event | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate |
|---|---|---|
| DiarrheaGastrointestinal disorders | 90/1107 | 45/1107 |
| NauseaGastrointestinal disorders | 48/1107 | 48/1107 |
| HeadacheNervous system disorders | 24/1107 | 17/1107 |
| Vulvovaginal mycotic infectionInfections and infestations | 20/1107 | 4/1107 |
| VomitingGastrointestinal disorders | 16/1107 | 4/1107 |
Microbiological modified intent-to-treat population
| Age, Continuous(years) | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate | Total |
|---|---|---|---|
| Mean | 50.3 ± 17.31 | 48.6 ± 17.18 | 49.5 ± 17.26 |
| Sex: Female, Male(Participants) | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate | Total |
|---|---|---|---|
| Female | 522 | 468 | 990 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate | Total |
|---|---|---|---|
| Hispanic or Latino | 333 | 296 | 629 |
| Not Hispanic or Latino | 189 | 171 | 360 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 10 | 8 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 84 | 84 | 168 |
| White | 419 | 370 | 789 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 4 | 12 |
| Region of Enrollment(participants) | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate | Total |
|---|---|---|---|
| United States | 522 | 468 | 990 |
| Diabetes(Participants) | Sulopenem Etzadroxil/Probenecid | Amoxicillin/Clavulanate | Total |
|---|---|---|---|
| Count of participants | 86 | 68 | 154 |
Showing the first 100 of 167 sites. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2022 to primary completion in Nov 2023, 12 months.
Results were first posted in Nov 2024, 1 year after primary completion.
Of 23 industry-sponsored phase 3 interventional studies under Urinary Tract Infections, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's 12 months is below that.
Counting every sponsor, half of 37 studies reached it within 20 months; a quarter within 14 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sulopenem etzadroxil · Probenecid
Iterum Therapeutics, International Limited