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

April 19, 2024 updated by: Iterum Therapeutics, International Limited

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

IT001-310 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

2229

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Medical Facility
      • Saraland, Alabama, United States, 36571
        • Medical Facility
      • Sheffield, Alabama, United States, 35660
        • Medical Facility
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Medical Facility
      • Phoenix, Arizona, United States, 85032
        • Medical Facility
      • Phoenix, Arizona, United States, 85031
        • Medical Facility3
      • Phoenix, Arizona, United States, 85051
        • Medical Facility2
      • Tucson, Arizona, United States, 85715
        • Medical Facility
    • Arkansas
      • Hot Springs, Arkansas, United States, 71901
        • Medical Facility2
      • Hot Springs, Arkansas, United States, 71913
        • Medical Facility
    • California
      • Bakersfield, California, United States, 93309
        • Medical Facility
      • Chula Vista, California, United States, 91911
        • Medical Facility
      • Fullerton, California, United States, 92835
        • Medical Facility
      • Garden Grove, California, United States, 92844
        • Medical Facility
      • Huntington Beach, California, United States, 92648
        • Medical Facility
      • Huntington Park, California, United States, 90255
        • Medical Facility 2
      • Huntington Park, California, United States, 90255
        • Medical Facility
      • Irvine, California, United States, 92614
        • Medical Facility
      • La Mesa, California, United States, 91942
        • Medical Facility
      • Lancaster, California, United States, 93534
        • Medical Facility
      • Lomita, California, United States, 90717
        • Medical Facility
      • Los Angeles, California, United States, 90057
        • Medical Facility
      • Los Angeles, California, United States, 90017
        • Medical Facility2
      • Pomona, California, United States, 91768
        • Medical Facility
      • Sacramento, California, United States, 95821
        • Medical Facility
      • San Diego, California, United States, 92111
        • Medical Facility
      • Upland, California, United States, 91786
        • Medical Facility
      • Victorville, California, United States, 92395
        • Medical Facility
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Medical Facility
      • Lakewood, Colorado, United States, 80228
        • Medical Facility
    • Florida
      • Aventura, Florida, United States, 33180
        • Medical Facility
      • Boynton Beach, Florida, United States, 33435
        • Medical Facility
      • Cape Coral, Florida, United States, 33909
        • Medical Facility
      • Doral, Florida, United States, 33166
        • Medical Facility
      • Edgewater, Florida, United States, 32132
        • Medical Facility
      • Hialeah, Florida, United States, 33016
        • Medical Facility
      • Hollywood, Florida, United States, 33024
        • Medical Facility
      • Homestead, Florida, United States, 33032
        • Medical Facility
      • Lake Worth, Florida, United States, 33460
        • Medical Facility
      • Lake Worth, Florida, United States, 33461
        • Medical Facility2
      • Leesburg, Florida, United States, 34748
        • Medical Facility
      • Miami, Florida, United States, 33165
        • Medical Facility
      • Miami, Florida, United States, 33126
        • Medical Facility3
      • Miami, Florida, United States, 33135
        • Medical Facility2
      • Miami, Florida, United States, 33173
        • Medical Facility9
      • Miami, Florida, United States, 33175
        • Medical Facility5
      • Miami, Florida, United States, 33176
        • Medical Facility8
      • Miami, Florida, United States, 33179
        • Medical Facility6
      • Miami, Florida, United States, 33184
        • Medical Facility7
      • Miami, Florida, United States, 33186
        • Medical Facility4
      • Miami Beach, Florida, United States, 33140
        • Medical Facility
      • Miami Gardens, Florida, United States, 33056
        • Medical Facility
      • Miami Lakes, Florida, United States, 33016
        • Medical Facility2
      • Miami Lakes, Florida, United States, 33317
        • Medical Facility
      • Orlando, Florida, United States, 32806
        • Medical Facility
      • Orlando, Florida, United States, 32812
        • Medical Facility2
      • Ormond Beach, Florida, United States, 32174
        • Medical Facility
      • Pompano Beach, Florida, United States, 33060
        • Medical Facility
      • Sweetwater, Florida, United States, 33172
        • Medical Facility
      • Tamarac, Florida, United States, 33321
        • Medical Facility
      • Tampa, Florida, United States, 33603
        • Medical Facility
      • Tampa, Florida, United States, 33607
        • Medical Facility3
      • Tampa, Florida, United States, 33607
        • Medical Facility4
      • Tampa, Florida, United States, 33614
        • Medical Facility2
      • Tampa, Florida, United States, 33634
        • Medical Facility5
      • Winter Haven, Florida, United States, 33880
        • Medical Facility
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Medical Facility
      • Atlanta, Georgia, United States, 30309
        • Medical Facility3
      • Atlanta, Georgia, United States, 30329
        • Medical Facility2
      • Decatur, Georgia, United States, 30034
        • Medical Facility
      • Lawrenceville, Georgia, United States, 30046
        • Medical Facility
      • Union City, Georgia, United States, 30291
        • Medical Facility
      • Woodstock, Georgia, United States, 30189
        • Medical Facility
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Medical Facility
      • Idaho Falls, Idaho, United States, 83404
        • Medical Facility
      • Idaho Falls, Idaho, United States, 08340
        • Medical Facility2
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Medical Facility
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Medical Facility
      • Mandeville, Louisiana, United States, 70471
        • Medical Facility
      • Marrero, Louisiana, United States, 70072
        • Medical Facility
      • Metairie, Louisiana, United States, 70001
        • Medical Facility
      • New Orleans, Louisiana, United States, 70124
        • Medical Facility
      • New Orleans, Louisiana, United States, 70127
        • Medical Facility2
      • Prairieville, Louisiana, United States, 70769
        • Medical Facility
      • Shreveport, Louisiana, United States, 71106
        • Medical Facility
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Medical Facility
      • Oxon Hill, Maryland, United States, 20745
        • Medical Facility
      • Towson, Maryland, United States, 21204
        • Medical Facility
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • Medical Facility
      • Gulfport, Mississippi, United States, 39503
        • Medical Facility
      • Jackson, Mississippi, United States, 39202
        • Medical Facility
      • Ridgeland, Mississippi, United States, 39157
        • Medical Facility
    • Montana
      • Great Falls, Montana, United States, 59405
        • Medical Facility
      • Kalispell, Montana, United States, 59901
        • Medical Facility
      • Missoula, Montana, United States, 59804
        • Medical Facility
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Medical Facility
      • Las Vegas, Nevada, United States, 89113
        • Medical Facility2
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Medical Facility2
      • Albuquerque, New Mexico, United States, 87109
        • Medical Facility
    • New York
      • Bronx, New York, United States, 10456
        • Medical Facility
      • Brooklyn, New York, United States, 11215
        • Medical Facility
      • Brooklyn, New York, United States, 11229
        • Medical Facility2
      • Garden City, New York, United States, 11530
        • Medical Facility
      • Schenectady, New York, United States, 12304
        • Medical Facility
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Medical Facility
      • Greensboro, North Carolina, United States, 27405
        • Medical Facility
      • New Bern, North Carolina, United States, 28562
        • Medical Facility
      • Winston-Salem, North Carolina, United States, 27103
        • Medical Facility
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Medical Facility
      • Columbus, Ohio, United States, 43213
        • Medical Facility2
      • Columbus, Ohio, United States, 43228
        • Medical Facility
      • Dayton, Ohio, United States, 45409
        • Medical Facility
      • Dayton, Ohio, United States, 45424
        • Medical Facility2
      • Lima, Ohio, United States, 45805
        • Medical Facility
      • Middleburg Heights, Ohio, United States, 44130
        • Medical Facility
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Medical Facility
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Medical Facility
      • Portland, Oregon, United States, 97202
        • Medical Facility
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Medical Facility
      • Scottdale, Pennsylvania, United States, 15683
        • Medical Facility
      • Smithfield, Pennsylvania, United States, 15478
        • Medical Facility
      • Upper Saint Clair, Pennsylvania, United States, 15241
        • Medical Facility
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Medical Facility
      • Easley, South Carolina, United States, 29640
        • Medical Facility
      • Greenville, South Carolina, United States, 29607
        • Medical Facility
      • Lancaster, South Carolina, United States, 29720
        • Medical Facility
      • Myrtle Beach, South Carolina, United States, 29572
        • Medical Facility
      • Powdersville, South Carolina, United States, 29611
        • Medical Facility
      • Seneca, South Carolina, United States, 29678
        • Medical Facility
      • Summerville, South Carolina, United States, 29485
        • Medical Facility
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Medical Facility2
      • Chattanooga, Tennessee, United States, 37421
        • Medical Facility
      • Hendersonville, Tennessee, United States, 37075
        • Medical Facility
      • Memphis, Tennessee, United States, 38120
        • Medical Facility
      • Nashville, Tennessee, United States, 37209
        • Medical Facility
    • Texas
      • Austin, Texas, United States, 78723
        • Medical Facility
      • Carrollton, Texas, United States, 75007
        • Medical Facility
      • Carrollton, Texas, United States, 75010
        • Medical Facility2
      • Corpus Christi, Texas, United States, 78404
        • Medical Facility
      • Dallas, Texas, United States, 75209
        • Medical Facility
      • Frisco, Texas, United States, 75033
        • Medical Facility
      • Georgetown, Texas, United States, 79628
        • Medical Facility
      • Houston, Texas, United States, 77036
        • Medical Facility2
      • Houston, Texas, United States, 77074
        • Medical Facility
      • Kingwood, Texas, United States, 77339
        • Medical Facility
      • League City, Texas, United States, 77573
        • Medical Facility
      • McKinney, Texas, United States, 75069
        • Medical Facility2
      • McKinney, Texas, United States, 75070
        • Medical Facility
      • Mesquite, Texas, United States, 75149
        • Medical Facility2
      • Mesquite, Texas, United States, 75149
        • Medical Facility
      • Missouri City, Texas, United States, 77459
        • Medical Facility
      • Pearland, Texas, United States, 77584
        • Medical Facility
      • Plano, Texas, United States, 75024
        • Medical Facility2
      • Plano, Texas, United States, 75093
        • Medical Facility
      • San Antonio, Texas, United States, 78215
        • Medical Facility
      • Sugar Land, Texas, United States, 77479
        • Medical Facility 2
      • Sugar Land, Texas, United States, 77479
        • Medical Facility3
      • Sugar Land, Texas, United States, 77479
        • Medical Facility
    • Utah
      • Draper, Utah, United States, 84020
        • Medical Facility 2
      • Draper, Utah, United States, 84020
        • Medical Facility
      • Pleasant Grove, Utah, United States, 84062
        • Medical Facility
      • Salt Lake City, Utah, United States, 84107
        • Medical Facility
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Medical Facility
      • Manassas, Virginia, United States, 20110
        • Medical Facility
      • Norfolk, Virginia, United States, 23502
        • Medical Facility
    • West Virginia
      • Kingwood, West Virginia, United States, 26537
        • Medical Facility
      • Morgantown, West Virginia, United States, 26505
        • Medical Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sulopenem etzadroxil/probenecid
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Drug: Sulopenem etzadroxil/probenecid
Oral sulopenem twice daily for 5 days
Other Names:
  • Oral sulopenem
Active Comparator: Amoxicillin/clavulanate
Amoxicillin/clavulanate PO twice daily for 5 days
Drug: Amoxicillin/clavulanate
Oral Augmentin twice daily for 5 days
Other Names:
  • Augmentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants with Overall Success
Time Frame: 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)
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success
Time Frame: 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)
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
Time Frame: 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)
Day 12+/-1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Modified Intent to Treat (MITT) Participants With Clinical Success
Time Frame: Day 12+/-1 day
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Clinical Success
Time Frame: Day 12+/-1 day
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Clinical Success
Time Frame: Day 12+/-1 day
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Clinical Success
Time Frame: Day 12+/-1 day
Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Asymptomatic Bacteriuria
Time Frame: Day 12+/-1 day
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen)
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Asymptomatic Bacteriuria
Time Frame: Day 12+/-1 day
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Asymptomatic Bacteriuria
Time Frame: Day 12+/-1 day
Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Microbiologic Success
Time Frame: Day 12+/-1 day
Microbiologic Success: Eradication of the Baseline Pathogen
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Microbiologic Success
Time Frame: Day 12+/-1 day
Microbiologic Success: Eradication of the Baseline Pathogen
Day 12+/-1 day
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Microbiologic Success
Time Frame: Day 12+/-1 day
Microbiologic Success: Eradication of the Baseline Pathogen
Day 12+/-1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iterum Therapeutics, International Limited

Investigators

  • Study Director: Sailaja Puttagunta, MD, Iterum Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Actual)

November 3, 2023

Study Completion (Actual)

November 21, 2023

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT001-310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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