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Urinary Tract InfectionsPhase 3REASSURENCT05584657

Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

A Phase 3 study testing Sulopenem etzadroxil/probenecid and Amoxicillin/clavulanate in people with Urinary Tract Infections and Cystitis, run by Iterum Therapeutics, International Limited at 167 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Urinary Tract Infections, Cystitis
What is being tested?
Sulopenem etzadroxil/probenecid and Amoxicillin/clavulanate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,229 participants
Where
167 sitesUnited States
Study dates
18 Oct 2022to 21 Nov 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI
  • Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
  • A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine

Who cannot join

  • Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature > 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
  • Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
  • Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
  • Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
  • Ongoing urinary retention
  • Neurogenic bladder
Show all 12Show fewer
  • Current resident of a long-term care facility
  • Instrumentation of urinary tract in the previous 30 days
  • An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
  • Any history of trauma to the pelvis or urinary tract
  • Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
  • History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients

Trial locations and contacts

167 sites in 1 country.

167 sites in 1 country

United States167 sites

  • Medical Facility2

    Albuquerque, New Mexico, 87102

  • Medical Facility

    Albuquerque, New Mexico, 87109

  • Medical Facility3

    Atlanta, Georgia, 30309

  • Medical Facility2

    Atlanta, Georgia, 30329

  • Medical Facility

    Atlanta, Georgia, 30342

  • Medical Facility

    Austin, Texas, 78723

  • Medical Facility

    Aventura, Florida, 33180

  • Medical Facility

    Bakersfield, California, 93309

  • Medical Facility

    Beaver, Pennsylvania, 15009

  • Medical Facility

    Blackfoot, Idaho, 83221

  • Medical Facility

    Boynton Beach, Florida, 33435

  • Medical Facility

    Brooklyn, New York, 11215

  • Medical Facility2

    Brooklyn, New York, 11229

  • Medical Facility

    Cape Coral, Florida, 33909

  • Medical Facility

    Carrollton, Texas, 75007

  • Medical Facility2

    Carrollton, Texas, 75010

  • Medical Facility

    Charleston, South Carolina, 29414

  • Medical Facility

    Charlotte, North Carolina, 28277

  • Medical Facility2

    Chattanooga, Tennessee, 37404

  • Medical Facility

    Chattanooga, Tennessee, 37421

  • Medical Facility

    Chicago, Illinois, 60643

  • Medical Facility

    Chula Vista, California, 91911

  • Medical Facility

    Cincinnati, Ohio, 45219

  • Medical Facility

    Columbia, Maryland, 21045

  • Medical Facility2

    Columbus, Ohio, 43213

  • Medical Facility

    Columbus, Ohio, 43228

  • Medical Facility

    Corpus Christi, Texas, 78404

  • Medical Facility

    Cullman, Alabama, 35055

  • Medical Facility

    Dallas, Texas, 75209

  • Medical Facility

    Dayton, Ohio, 45409

  • Medical Facility2

    Dayton, Ohio, 45424

  • Medical Facility

    Decatur, Georgia, 30034

  • Medical Facility

    Doral, Florida, 33166

  • Medical Facility 2

    Draper, Utah, 84020

  • Medical Facility

    Draper, Utah, 84020

  • Medical Facility

    Easley, South Carolina, 29640

  • Medical Facility

    Edgewater, Florida, 32132

  • Medical Facility

    Eugene, Oregon, 97404

  • Medical Facility

    Eunice, Louisiana, 70535

  • Medical Facility

    Falls Church, Virginia, 22042

  • Medical Facility

    Fayette, Mississippi, 39069

  • Medical Facility

    Frisco, Texas, 75033

  • Medical Facility

    Fullerton, California, 92835

  • Medical Facility

    Garden City, New York, 11530

  • Medical Facility

    Garden Grove, California, 92844

  • Medical Facility

    Georgetown, Texas, 79628

  • Medical Facility

    Grand Junction, Colorado, 81501

  • Medical Facility

    Great Falls, Montana, 59405

  • Medical Facility

    Greensboro, North Carolina, 27405

  • Medical Facility

    Greenville, South Carolina, 29607

  • Medical Facility

    Gulfport, Mississippi, 39503

  • Medical Facility

    Hendersonville, Tennessee, 37075

  • Medical Facility

    Hialeah, Florida, 33016

  • Medical Facility

    Hollywood, Florida, 33024

  • Medical Facility

    Homestead, Florida, 33032

  • Medical Facility2

    Hot Springs, Arkansas, 71901

  • Medical Facility

    Hot Springs, Arkansas, 71913

  • Medical Facility2

    Houston, Texas, 77036

  • Medical Facility

    Houston, Texas, 77074

  • Medical Facility

    Huntington Beach, California, 92648

  • Medical Facility 2

    Huntington Park, California, 90255

  • Medical Facility

    Huntington Park, California, 90255

  • Medical Facility2

    Idaho Falls, Idaho, 08340

  • Medical Facility

    Idaho Falls, Idaho, 83404

  • Medical Facility

    Irvine, California, 92614

  • Medical Facility

    Jackson, Mississippi, 39202

  • Medical Facility

    Kalispell, Montana, 59901

  • Medical Facility

    Kingwood, Texas, 77339

  • Medical Facility

    Kingwood, West Virginia, 26537

  • Medical Facility

    La Mesa, California, 91942

  • Medical Facility

    Lake Worth, Florida, 33460

  • Medical Facility2

    Lake Worth, Florida, 33461

  • Medical Facility

    Lakewood, Colorado, 80228

  • Medical Facility

    Lancaster, California, 93534

  • Medical Facility

    Lancaster, South Carolina, 29720

  • Medical Facility2

    Las Vegas, Nevada, 89113

  • Medical Facility

    Las Vegas, Nevada, 89121

  • Medical Facility

    Lawrenceville, Georgia, 30046

  • Medical Facility

    League City, Texas, 77573

  • Medical Facility

    Leesburg, Florida, 34748

  • Medical Facility

    Lima, Ohio, 45805

  • Medical Facility

    Lomita, California, 90717

  • Medical Facility2

    Los Angeles, California, 90017

  • Medical Facility

    Los Angeles, California, 90057

  • Medical Facility

    Manassas, Virginia, 20110

  • Medical Facility

    Mandeville, Louisiana, 70471

  • Medical Facility

    Marrero, Louisiana, 70072

  • Medical Facility2

    McKinney, Texas, 75069

  • Medical Facility

    McKinney, Texas, 75070

  • Medical Facility

    Memphis, Tennessee, 38120

  • Medical Facility2

    Mesquite, Texas, 75149

  • Medical Facility

    Mesquite, Texas, 75149

  • Medical Facility

    Metairie, Louisiana, 70001

  • Medical Facility3

    Miami, Florida, 33126

  • Medical Facility2

    Miami, Florida, 33135

  • Medical Facility

    Miami, Florida, 33165

  • Medical Facility9

    Miami, Florida, 33173

  • Medical Facility5

    Miami, Florida, 33175

  • Medical Facility8

    Miami, Florida, 33176

  • Medical Facility6

    Miami, Florida, 33179

  • Medical Facility7

    Miami, Florida, 33184

  • Medical Facility4

    Miami, Florida, 33186

  • Medical Facility

    Miami Beach, Florida, 33140

  • Medical Facility

    Miami Gardens, Florida, 33056

  • Medical Facility2

    Miami Lakes, Florida, 33016

  • Medical Facility

    Miami Lakes, Florida, 33317

  • Medical Facility

    Middleburg Heights, Ohio, 44130

  • Medical Facility

    Missoula, Montana, 59804

  • Medical Facility

    Missouri City, Texas, 77459

  • Medical Facility

    Morgantown, West Virginia, 26505

  • Medical Facility

    Myrtle Beach, South Carolina, 29572

  • Medical Facility

    Nashville, Tennessee, 37209

  • Medical Facility

    New Bern, North Carolina, 28562

  • Medical Facility

    New Orleans, Louisiana, 70124

  • Medical Facility2

    New Orleans, Louisiana, 70127

  • Medical Facility

    Norfolk, Virginia, 23502

  • Medical Facility

    Orlando, Florida, 32806

  • Medical Facility2

    Orlando, Florida, 32812

  • Medical Facility

    Ormond Beach, Florida, 32174

  • Medical Facility

    Oxon Hill, Maryland, 20745

  • Medical Facility

    Pearland, Texas, 77584

  • Medical Facility

    Peoria, Arizona, 85381

  • Medical Facility3

    Phoenix, Arizona, 85031

  • Medical Facility

    Phoenix, Arizona, 85032

  • Medical Facility2

    Phoenix, Arizona, 85051

  • Medical Facility2

    Plano, Texas, 75024

  • Medical Facility

    Plano, Texas, 75093

  • Medical Facility

    Pleasant Grove, Utah, 84062

  • Medical Facility

    Pomona, California, 91768

  • Medical Facility

    Pompano Beach, Florida, 33060

  • Medical Facility

    Portland, Oregon, 97202

  • Medical Facility

    Powdersville, South Carolina, 29611

  • Medical Facility

    Prairieville, Louisiana, 70769

  • Medical Facility

    Ridgeland, Mississippi, 39157

  • Medical Facility

    Sacramento, California, 95821

  • Medical Facility

    Salt Lake City, Utah, 84107

  • Medical Facility

    San Antonio, Texas, 78215

  • Medical Facility

    San Diego, California, 92111

  • Medical Facility

    Saraland, Alabama, 36571

  • Medical Facility

    Schenectady, New York, 12304

  • Medical Facility

    Scottdale, Pennsylvania, 15683

  • Medical Facility

    Seneca, South Carolina, 29678

  • Medical Facility

    Sheffield, Alabama, 35660

  • Medical Facility

    Shreveport, Louisiana, 71106

  • Medical Facility

    Smithfield, Pennsylvania, 15478

  • Medical Facility 2

    Sugar Land, Texas, 77479

  • Medical Facility3

    Sugar Land, Texas, 77479

  • Medical Facility

    Sugar Land, Texas, 77479

  • Medical Facility

    Summerville, South Carolina, 29485

  • Medical Facility

    Sweetwater, Florida, 33172

  • Medical Facility

    Tamarac, Florida, 33321

  • Medical Facility

    Tampa, Florida, 33603

  • Medical Facility3

    Tampa, Florida, 33607

  • Medical Facility4

    Tampa, Florida, 33607

  • Medical Facility2

    Tampa, Florida, 33614

  • Medical Facility5

    Tampa, Florida, 33634

  • Medical Facility

    The Bronx, New York, 10456

  • Medical Facility

    Towson, Maryland, 21204

  • Medical Facility

    Tucson, Arizona, 85715

  • Medical Facility

    Tulsa, Oklahoma, 74133

  • Medical Facility

    Union City, Georgia, 30291

  • Medical Facility

    Upland, California, 91786

  • Medical Facility

    Upper Saint Clair, Pennsylvania, 15241

  • Medical Facility

    Victorville, California, 92395

  • Medical Facility

    Winston-Salem, North Carolina, 27103

  • Medical Facility

    Winter Haven, Florida, 33880

  • Medical Facility

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

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.

Read the detailed description

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).

Being tested
Sulopenem etzadroxil/probenecid, Amoxicillin/clavulanate
Medical subject headings
Urinary Tract Infections, Cystitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sulopenem etzadroxil/probenecidDrug

    Also called Oral sulopenem

    Oral sulopenem twice daily for 5 days

  • Amoxicillin/clavulanateDrug

    Also called Augmentin

    Oral Augmentin twice daily for 5 days

Study groups in NCT05584657
Study groupRoleWhat they receive
Sulopenem etzadroxil/probenecidExperimentalSulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Receives: Drug: Sulopenem etzadroxil/probenecid
Amoxicillin/clavulanateActive comparatorAmoxicillin/clavulanate PO twice daily for 5 days
Receives: Drug: Amoxicillin/clavulanate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 12+/-1 day

  2. 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)

    Measured: Day 12+/-1 day

Secondary outcomes (5)

  1. Clinical Success Modified Intent-to-treat Population

    Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms

    Measured: Day 12+/-1 day

  2. Clinical Success

    Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms

    Measured: Day 12+/-1 day

  3. Clinical Success Susceptible Population

    Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms

    Measured: Day 12+/-1 day

  4. Microbiologic Success

    Eradication of the Baseline Pathogen

    Measured: Day 12+/-1 day

  5. Microbiologic Success Susceptible Population

    Microbiologic Success: Eradication of the Baseline Pathogen

    Measured: Day 12+/-1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start18 Oct 2022
  3. Primary completion3 Nov 2023
  4. Study completion21 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05584657
Sponsor's protocol ID
IT001-310
Acronym
REASSURE
Status last verified
Oct 2024
First submitted
14 Oct 2022
Last updated
20 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Publications

  • Puttagunta S, Aronin SI, Gupta J, Das AF, Gupta K, Dunne MW. Sulopenem versus Amoxicillin/Clavulanate for the Treatment of Uncomplicated Urinary Tract Infection. NEJM Evid. 2025 Jul;4(7):EVIDoa2400414. doi: 10.1056/EVIDoa2400414. Epub 2025 Jun 24.

    PubMed 40552968

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sulopenem etzadroxil/probenecid and Amoxicillin/clavulanate in people with Urinary Tract Infections and Cystitis, run by Iterum Therapeutics, International Limited at 167 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success (time frame: Day 12+/-1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05584657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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