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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT05584657

Public ClinicalTrials.gov record NCT05584657. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 3:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT05584657
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Iterum Therapeutics, International Limited
Industry
Enrollment
2,229 participants

Conditions and interventions

Interventions

  • Sulopenem etzadroxil/probenecid Drug
  • Amoxicillin/clavulanate Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 17, 2022
Primary completion
Nov 2, 2023
Completion
Nov 20, 2023
Last update posted
Nov 19, 2024

2022 – 2023

United States locations

U.S. sites
167
U.S. states
27
U.S. cities
129
Facility City State ZIP Site status
Medical Facility Cullman Alabama 35055
Medical Facility Saraland Alabama 36571
Medical Facility Sheffield Alabama 35660
Medical Facility Peoria Arizona 85381
Medical Facility3 Phoenix Arizona 85031
Medical Facility Phoenix Arizona 85032
Medical Facility2 Phoenix Arizona 85051
Medical Facility Tucson Arizona 85715
Medical Facility2 Hot Springs Arkansas 71901
Medical Facility Hot Springs Arkansas 71913
Medical Facility Bakersfield California 93309
Medical Facility Chula Vista California 91911
Medical Facility Fullerton California 92835
Medical Facility Garden Grove California 92844
Medical Facility Huntington Beach California 92648
Medical Facility 2 Huntington Park California 90255
Medical Facility Huntington Park California 90255
Medical Facility Irvine California 92614
Medical Facility La Mesa California 91942
Medical Facility Lancaster California 93534
Medical Facility Lomita California 90717
Medical Facility2 Los Angeles California 90017
Medical Facility Los Angeles California 90057
Medical Facility Pomona California 91768
Medical Facility Sacramento California 95821
Medical Facility San Diego California 92111
Medical Facility Upland California 91786
Medical Facility Victorville California 92395
Medical Facility Grand Junction Colorado 81501
Medical Facility Lakewood Colorado 80228
Medical Facility Aventura Florida 33180
Medical Facility Boynton Beach Florida 33435
Medical Facility Cape Coral Florida 33909
Medical Facility Doral Florida 33166
Medical Facility Edgewater Florida 32132
Medical Facility Hialeah Florida 33016
Medical Facility Hollywood Florida 33024
Medical Facility Homestead Florida 33032
Medical Facility Lake Worth Florida 33460
Medical Facility2 Lake Worth Florida 33461
Medical Facility Leesburg Florida 34748
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 Orlando Florida 32806
Medical Facility2 Orlando Florida 32812
Medical Facility Ormond Beach Florida 32174
Medical Facility Pompano Beach Florida 33060
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 Winter Haven Florida 33880
Medical Facility3 Atlanta Georgia 30309
Medical Facility2 Atlanta Georgia 30329
Medical Facility Atlanta Georgia 30342
Medical Facility Decatur Georgia 30034
Medical Facility Lawrenceville Georgia 30046
Medical Facility Union City Georgia 30291
Medical Facility Woodstock Georgia 30189
Medical Facility Blackfoot Idaho 83221
Medical Facility2 Idaho Falls Idaho 08340
Medical Facility Idaho Falls Idaho 83404
Medical Facility Chicago Illinois 60643
Medical Facility Eunice Louisiana 70535
Medical Facility Mandeville Louisiana 70471
Medical Facility Marrero Louisiana 70072
Medical Facility Metairie Louisiana 70001
Medical Facility New Orleans Louisiana 70124
Medical Facility2 New Orleans Louisiana 70127
Medical Facility Prairieville Louisiana 70769
Medical Facility Shreveport Louisiana 71106
Medical Facility Columbia Maryland 21045
Medical Facility Oxon Hill Maryland 20745
Medical Facility Towson Maryland 21204
Medical Facility Fayette Mississippi 39069
Medical Facility Gulfport Mississippi 39503
Medical Facility Jackson Mississippi 39202
Medical Facility Ridgeland Mississippi 39157
Medical Facility Great Falls Montana 59405
Medical Facility Kalispell Montana 59901
Medical Facility Missoula Montana 59804
Medical Facility2 Las Vegas Nevada 89113
Medical Facility Las Vegas Nevada 89121
Medical Facility2 Albuquerque New Mexico 87102
Medical Facility Albuquerque New Mexico 87109
Medical Facility Brooklyn New York 11215
Medical Facility2 Brooklyn New York 11229
Medical Facility Garden City New York 11530
Medical Facility Schenectady New York 12304
Medical Facility The Bronx New York 10456
Medical Facility Charlotte North Carolina 28277
Medical Facility Greensboro North Carolina 27405
Medical Facility New Bern North Carolina 28562
Medical Facility Winston-Salem North Carolina 27103
Medical Facility Cincinnati Ohio 45219
Medical Facility2 Columbus Ohio 43213
Medical Facility Columbus Ohio 43228
Medical Facility Dayton Ohio 45409
Medical Facility2 Dayton Ohio 45424
Medical Facility Lima Ohio 45805
Medical Facility Middleburg Heights Ohio 44130
Medical Facility Tulsa Oklahoma 74133
Medical Facility Eugene Oregon 97404
Medical Facility Portland Oregon 97202
Medical Facility Beaver Pennsylvania 15009
Medical Facility Scottdale Pennsylvania 15683
Medical Facility Smithfield Pennsylvania 15478
Medical Facility Upper Saint Clair Pennsylvania 15241
Medical Facility Charleston South Carolina 29414
Medical Facility Easley South Carolina 29640
Medical Facility Greenville South Carolina 29607
Medical Facility Lancaster South Carolina 29720
Medical Facility Myrtle Beach South Carolina 29572
Medical Facility Powdersville South Carolina 29611
Medical Facility Seneca South Carolina 29678
Medical Facility Summerville South Carolina 29485
Medical Facility2 Chattanooga Tennessee 37404
Medical Facility Chattanooga Tennessee 37421
Medical Facility Hendersonville Tennessee 37075
Medical Facility Memphis Tennessee 38120
Medical Facility Nashville Tennessee 37209
Medical Facility Austin Texas 78723
Medical Facility Carrollton Texas 75007
Medical Facility2 Carrollton Texas 75010
Medical Facility Corpus Christi Texas 78404
Medical Facility Dallas Texas 75209
Medical Facility Frisco Texas 75033
Medical Facility Georgetown Texas 79628
Medical Facility2 Houston Texas 77036
Medical Facility Houston Texas 77074
Medical Facility Kingwood Texas 77339
Medical Facility League City Texas 77573
Medical Facility2 McKinney Texas 75069
Medical Facility McKinney Texas 75070
Medical Facility2 Mesquite Texas 75149
Medical Facility Mesquite Texas 75149
Medical Facility Missouri City Texas 77459
Medical Facility Pearland Texas 77584
Medical Facility2 Plano Texas 75024
Medical Facility Plano Texas 75093
Medical Facility San Antonio Texas 78215
Medical Facility 2 Sugar Land Texas 77479
Medical Facility3 Sugar Land Texas 77479
Medical Facility Sugar Land Texas 77479
Medical Facility 2 Draper Utah 84020
Medical Facility Draper Utah 84020
Medical Facility Pleasant Grove Utah 84062
Medical Facility Salt Lake City Utah 84107
Medical Facility Falls Church Virginia 22042
Medical Facility Manassas Virginia 20110
Medical Facility Norfolk Virginia 23502
Medical Facility Kingwood West Virginia 26537
Medical Facility Morgantown West Virginia 26505

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05584657, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 19, 2024 · Synced Jul 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05584657 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →