Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
REASSURE
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
1 other identifier
interventional
2,229
1 country
167
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2022
Shorter than P25 for phase_3
167 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedStudy Start
First participant enrolled
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2023
CompletedResults Posted
Study results publicly available
November 20, 2024
CompletedNovember 20, 2024
October 1, 2024
1 year
October 14, 2022
October 30, 2024
October 30, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
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)
Day 12+/-1 day
Secondary Outcomes (5)
Clinical Success Modified Intent-to-treat Population
Day 12+/-1 day
Clinical Success
Day 12+/-1 day
Clinical Success Susceptible Population
Day 12+/-1 day
Microbiologic Success
Day 12+/-1 day
Microbiologic Success Susceptible Population
Day 12+/-1 day
Study Arms (2)
Sulopenem etzadroxil/probenecid
EXPERIMENTALSulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Amoxicillin/clavulanate
ACTIVE COMPARATORAmoxicillin/clavulanate PO twice daily for 5 days
Interventions
Oral sulopenem twice daily for 5 days
Oral Augmentin twice daily for 5 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (167)
Medical Facility
Cullman, Alabama, 35055, United States
Medical Facility
Saraland, Alabama, 36571, United States
Medical Facility
Sheffield, Alabama, 35660, United States
Medical Facility
Peoria, Arizona, 85381, United States
Medical Facility3
Phoenix, Arizona, 85031, United States
Medical Facility
Phoenix, Arizona, 85032, United States
Medical Facility2
Phoenix, Arizona, 85051, United States
Medical Facility
Tucson, Arizona, 85715, United States
Medical Facility2
Hot Springs, Arkansas, 71901, United States
Medical Facility
Hot Springs, Arkansas, 71913, United States
Medical Facility
Bakersfield, California, 93309, United States
Medical Facility
Chula Vista, California, 91911, United States
Medical Facility
Fullerton, California, 92835, United States
Medical Facility
Garden Grove, California, 92844, United States
Medical Facility
Huntington Beach, California, 92648, United States
Medical Facility 2
Huntington Park, California, 90255, United States
Medical Facility
Huntington Park, California, 90255, United States
Medical Facility
Irvine, California, 92614, United States
Medical Facility
La Mesa, California, 91942, United States
Medical Facility
Lancaster, California, 93534, United States
Medical Facility
Lomita, California, 90717, United States
Medical Facility2
Los Angeles, California, 90017, United States
Medical Facility
Los Angeles, California, 90057, United States
Medical Facility
Pomona, California, 91768, United States
Medical Facility
Sacramento, California, 95821, United States
Medical Facility
San Diego, California, 92111, United States
Medical Facility
Upland, California, 91786, United States
Medical Facility
Victorville, California, 92395, United States
Medical Facility
Grand Junction, Colorado, 81501, United States
Medical Facility
Lakewood, Colorado, 80228, United States
Medical Facility
Aventura, Florida, 33180, United States
Medical Facility
Boynton Beach, Florida, 33435, United States
Medical Facility
Cape Coral, Florida, 33909, United States
Medical Facility
Doral, Florida, 33166, United States
Medical Facility
Edgewater, Florida, 32132, United States
Medical Facility
Hialeah, Florida, 33016, United States
Medical Facility
Hollywood, Florida, 33024, United States
Medical Facility
Homestead, Florida, 33032, United States
Medical Facility
Lake Worth, Florida, 33460, United States
Medical Facility2
Lake Worth, Florida, 33461, United States
Medical Facility
Leesburg, Florida, 34748, United States
Medical Facility3
Miami, Florida, 33126, United States
Medical Facility2
Miami, Florida, 33135, United States
Medical Facility
Miami, Florida, 33165, United States
Medical Facility9
Miami, Florida, 33173, United States
Medical Facility5
Miami, Florida, 33175, United States
Medical Facility8
Miami, Florida, 33176, United States
Medical Facility6
Miami, Florida, 33179, United States
Medical Facility7
Miami, Florida, 33184, United States
Medical Facility4
Miami, Florida, 33186, United States
Medical Facility
Miami Beach, Florida, 33140, United States
Medical Facility
Miami Gardens, Florida, 33056, United States
Medical Facility2
Miami Lakes, Florida, 33016, United States
Medical Facility
Miami Lakes, Florida, 33317, United States
Medical Facility
Orlando, Florida, 32806, United States
Medical Facility2
Orlando, Florida, 32812, United States
Medical Facility
Ormond Beach, Florida, 32174, United States
Medical Facility
Pompano Beach, Florida, 33060, United States
Medical Facility
Sweetwater, Florida, 33172, United States
Medical Facility
Tamarac, Florida, 33321, United States
Medical Facility
Tampa, Florida, 33603, United States
Medical Facility3
Tampa, Florida, 33607, United States
Medical Facility4
Tampa, Florida, 33607, United States
Medical Facility2
Tampa, Florida, 33614, United States
Medical Facility5
Tampa, Florida, 33634, United States
Medical Facility
Winter Haven, Florida, 33880, United States
Medical Facility3
Atlanta, Georgia, 30309, United States
Medical Facility2
Atlanta, Georgia, 30329, United States
Medical Facility
Atlanta, Georgia, 30342, United States
Medical Facility
Decatur, Georgia, 30034, United States
Medical Facility
Lawrenceville, Georgia, 30046, United States
Medical Facility
Union City, Georgia, 30291, United States
Medical Facility
Woodstock, Georgia, 30189, United States
Medical Facility
Blackfoot, Idaho, 83221, United States
Medical Facility2
Idaho Falls, Idaho, 08340, United States
Medical Facility
Idaho Falls, Idaho, 83404, United States
Medical Facility
Chicago, Illinois, 60643, United States
Medical Facility
Eunice, Louisiana, 70535, United States
Medical Facility
Mandeville, Louisiana, 70471, United States
Medical Facility
Marrero, Louisiana, 70072, United States
Medical Facility
Metairie, Louisiana, 70001, United States
Medical Facility
New Orleans, Louisiana, 70124, United States
Medical Facility2
New Orleans, Louisiana, 70127, United States
Medical Facility
Prairieville, Louisiana, 70769, United States
Medical Facility
Shreveport, Louisiana, 71106, United States
Medical Facility
Columbia, Maryland, 21045, United States
Medical Facility
Oxon Hill, Maryland, 20745, United States
Medical Facility
Towson, Maryland, 21204, United States
Medical Facility
Fayette, Mississippi, 39069, United States
Medical Facility
Gulfport, Mississippi, 39503, United States
Medical Facility
Jackson, Mississippi, 39202, United States
Medical Facility
Ridgeland, Mississippi, 39157, United States
Medical Facility
Great Falls, Montana, 59405, United States
Medical Facility
Kalispell, Montana, 59901, United States
Medical Facility
Missoula, Montana, 59804, United States
Medical Facility2
Las Vegas, Nevada, 89113, United States
Medical Facility
Las Vegas, Nevada, 89121, United States
Medical Facility2
Albuquerque, New Mexico, 87102, United States
Medical Facility
Albuquerque, New Mexico, 87109, United States
Medical Facility
Brooklyn, New York, 11215, United States
Medical Facility2
Brooklyn, New York, 11229, United States
Medical Facility
Garden City, New York, 11530, United States
Medical Facility
Schenectady, New York, 12304, United States
Medical Facility
The Bronx, New York, 10456, United States
Medical Facility
Charlotte, North Carolina, 28277, United States
Medical Facility
Greensboro, North Carolina, 27405, United States
Medical Facility
New Bern, North Carolina, 28562, United States
Medical Facility
Winston-Salem, North Carolina, 27103, United States
Medical Facility
Cincinnati, Ohio, 45219, United States
Medical Facility2
Columbus, Ohio, 43213, United States
Medical Facility
Columbus, Ohio, 43228, United States
Medical Facility
Dayton, Ohio, 45409, United States
Medical Facility2
Dayton, Ohio, 45424, United States
Medical Facility
Lima, Ohio, 45805, United States
Medical Facility
Middleburg Heights, Ohio, 44130, United States
Medical Facility
Tulsa, Oklahoma, 74133, United States
Medical Facility
Eugene, Oregon, 97404, United States
Medical Facility
Portland, Oregon, 97202, United States
Medical Facility
Beaver, Pennsylvania, 15009, United States
Medical Facility
Scottdale, Pennsylvania, 15683, United States
Medical Facility
Smithfield, Pennsylvania, 15478, United States
Medical Facility
Upper Saint Clair, Pennsylvania, 15241, United States
Medical Facility
Charleston, South Carolina, 29414, United States
Medical Facility
Easley, South Carolina, 29640, United States
Medical Facility
Greenville, South Carolina, 29607, United States
Medical Facility
Lancaster, South Carolina, 29720, United States
Medical Facility
Myrtle Beach, South Carolina, 29572, United States
Medical Facility
Powdersville, South Carolina, 29611, United States
Medical Facility
Seneca, South Carolina, 29678, United States
Medical Facility
Summerville, South Carolina, 29485, United States
Medical Facility2
Chattanooga, Tennessee, 37404, United States
Medical Facility
Chattanooga, Tennessee, 37421, United States
Medical Facility
Hendersonville, Tennessee, 37075, United States
Medical Facility
Memphis, Tennessee, 38120, United States
Medical Facility
Nashville, Tennessee, 37209, United States
Medical Facility
Austin, Texas, 78723, United States
Medical Facility
Carrollton, Texas, 75007, United States
Medical Facility2
Carrollton, Texas, 75010, United States
Medical Facility
Corpus Christi, Texas, 78404, United States
Medical Facility
Dallas, Texas, 75209, United States
Medical Facility
Frisco, Texas, 75033, United States
Medical Facility
Georgetown, Texas, 79628, United States
Medical Facility2
Houston, Texas, 77036, United States
Medical Facility
Houston, Texas, 77074, United States
Medical Facility
Kingwood, Texas, 77339, United States
Medical Facility
League City, Texas, 77573, United States
Medical Facility2
McKinney, Texas, 75069, United States
Medical Facility
McKinney, Texas, 75070, United States
Medical Facility2
Mesquite, Texas, 75149, United States
Medical Facility
Mesquite, Texas, 75149, United States
Medical Facility
Missouri City, Texas, 77459, United States
Medical Facility
Pearland, Texas, 77584, United States
Medical Facility2
Plano, Texas, 75024, United States
Medical Facility
Plano, Texas, 75093, United States
Medical Facility
San Antonio, Texas, 78215, United States
Medical Facility 2
Sugar Land, Texas, 77479, United States
Medical Facility3
Sugar Land, Texas, 77479, United States
Medical Facility
Sugar Land, Texas, 77479, United States
Medical Facility 2
Draper, Utah, 84020, United States
Medical Facility
Draper, Utah, 84020, United States
Medical Facility
Pleasant Grove, Utah, 84062, United States
Medical Facility
Salt Lake City, Utah, 84107, United States
Medical Facility
Falls Church, Virginia, 22042, United States
Medical Facility
Manassas, Virginia, 20110, United States
Medical Facility
Norfolk, Virginia, 23502, United States
Medical Facility
Kingwood, West Virginia, 26537, United States
Medical Facility
Morgantown, West Virginia, 26505, United States
Related Publications (1)
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.
PMID: 40552968DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President and Head of Clinical Development
- Organization
- Iterum Therapeutics
Study Officials
- STUDY DIRECTOR
Sailaja Puttagunta, MD
Iterum Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 14, 2022
First Posted
October 18, 2022
Study Start
October 18, 2022
Primary Completion
November 3, 2023
Study Completion
November 21, 2023
Last Updated
November 20, 2024
Results First Posted
November 20, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share