Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women Clinical Trial Results and Information

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

ClinicalTrials.gov processed this data on October 30, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified October 2024 by Iterum Therapeutics, International Limited

Sponsor

Iterum Therapeutics, International Limited

Information Provided by (Responsible Party)

Iterum Therapeutics, International Limited

Clinicaltrials.gov Identifier

NCT05584657
Other Study ID Numbers: IT001-310
First Submitted: October 14, 2022
First Posted: October 18, 2022
Results First Posted: November 20, 2024
Last Update Posted: November 20, 2024
Last Verified: October 2024
History of Changes

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Study 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).

Condition or Disease	Intervention/Treatment
Urinary Tract Infections Cystitis	Drug: Sulopenem etzadroxil/probenecid Drug: Amoxicillin/clavulanate

Study Design

Study Type	Interventional
Actual Enrollment	2229 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
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 Start Date	October 18, 2022
Actual Primary Completion Date	November 3, 2023
Actual Study Completion Date	November 21, 2023

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
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
Amoxicillin/clavulanate Amoxicillin/clavulanate PO twice daily for 5 days	Drug: Amoxicillin/clavulanate

Outcome Measures

Primary Outcome Measures

Overall Success [Day 12+/-1 day]
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)
Overall Success Susceptible Population [Day 12+/-1 day]
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)

Secondary Outcome Measures

Clinical Success Modified Intent-to-treat Population [Day 12+/-1 day]
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Clinical Success [Day 12+/-1 day]
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Clinical Success Susceptible Population [Day 12+/-1 day]
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Microbiologic Success [Day 12+/-1 day]
Eradication of the Baseline Pathogen
Microbiologic Success Susceptible Population [Day 12+/-1 day]
Microbiologic Success: Eradication of the Baseline Pathogen

Eligibility Criteria

Ages Eligible for Study	18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study	Female
Accepts Healthy Volunteers	No
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

Contacts and Locations

Sponsors and Collaborators	Iterum Therapeutics, International Limited
Locations	Medical Facility \| Cullman, Alabama, United States, 35055 Medical Facility \| Saraland, Alabama, United States, 36571 Medical Facility \| Sheffield, Alabama, United States, 35660 Medical Facility \| Peoria, Arizona, United States, 85381 Medical Facility3 \| Phoenix, Arizona, United States, 85031 Medical Facility \| Phoenix, Arizona, United States, 85032 Medical Facility2 \| Phoenix, Arizona, United States, 85051 Medical Facility \| Tucson, Arizona, United States, 85715 Medical Facility2 \| Hot Springs, Arkansas, United States, 71901 Medical Facility \| Hot Springs, Arkansas, United States, 71913 Medical Facility \| 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 2 \| Huntington Park, California, United States, 90255 Medical Facility \| 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 Facility2 \| Los Angeles, California, United States, 90017 Medical Facility \| Los Angeles, California, United States, 90057 Medical Facility \| 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 \| Grand Junction, Colorado, United States, 81501 Medical Facility \| Lakewood, Colorado, United States, 80228 Medical Facility \| 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 Facility2 \| Lake Worth, Florida, United States, 33461 Medical Facility \| Leesburg, Florida, United States, 34748 Medical Facility \| Miami Beach, Florida, United States, 33140 Medical Facility \| Miami Gardens, Florida, United States, 33056 Medical Facility2 \| Miami Lakes, Florida, United States, 33016 Medical Facility \| Miami Lakes, Florida, United States, 33317 Medical Facility3 \| Miami, Florida, United States, 33126 Medical Facility2 \| Miami, Florida, United States, 33135 Medical Facility \| Miami, Florida, United States, 33165 Medical Facility9 \| Miami, Florida, United States, 33173 Medical Facility5 \| Miami, Florida, United States, 33175 Medical Facility8 \| Miami, Florida, United States, 33176 Medical Facility6 \| Miami, Florida, United States, 33179 Medical Facility7 \| Miami, Florida, United States, 33184 Medical Facility4 \| Miami, Florida, United States, 33186 Medical Facility \| Orlando, Florida, United States, 32806 Medical Facility2 \| Orlando, Florida, United States, 32812 Medical Facility \| 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 Facility3 \| Tampa, Florida, United States, 33607 Medical Facility4 \| Tampa, Florida, United States, 33607 Medical Facility2 \| Tampa, Florida, United States, 33614 Medical Facility5 \| Tampa, Florida, United States, 33634 Medical Facility \| Winter Haven, Florida, United States, 33880 Medical Facility3 \| Atlanta, Georgia, United States, 30309 Medical Facility2 \| Atlanta, Georgia, United States, 30329 Medical Facility \| Atlanta, Georgia, United States, 30342 Medical Facility \| 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 \| Blackfoot, Idaho, United States, 83221 Medical Facility2 \| Idaho Falls, Idaho, United States, 08340 Medical Facility \| Idaho Falls, Idaho, United States, 83404 Medical Facility \| Chicago, Illinois, United States, 60643 Medical Facility \| 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 Facility2 \| New Orleans, Louisiana, United States, 70127 Medical Facility \| Prairieville, Louisiana, United States, 70769 Medical Facility \| Shreveport, Louisiana, United States, 71106 Medical Facility \| Columbia, Maryland, United States, 21045 Medical Facility \| Oxon Hill, Maryland, United States, 20745 Medical Facility \| Towson, Maryland, United States, 21204 Medical Facility \| 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 \| Great Falls, Montana, United States, 59405 Medical Facility \| Kalispell, Montana, United States, 59901 Medical Facility \| Missoula, Montana, United States, 59804 Medical Facility2 \| Las Vegas, Nevada, United States, 89113 Medical Facility \| Las Vegas, Nevada, United States, 89121 Medical Facility2 \| Albuquerque, New Mexico, United States, 87102 Medical Facility \| Albuquerque, New Mexico, United States, 87109 Medical Facility \| Bronx, New York, United States, 10456 Medical Facility \| Brooklyn, New York, United States, 11215 Medical Facility2 \| Brooklyn, New York, United States, 11229 Medical Facility \| Garden City, New York, United States, 11530 Medical Facility \| Schenectady, New York, United States, 12304 Medical Facility \| 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 \| Cincinnati, Ohio, United States, 45219 Medical Facility2 \| Columbus, Ohio, United States, 43213 Medical Facility \| Columbus, Ohio, United States, 43228 Medical Facility \| Dayton, Ohio, United States, 45409 Medical Facility2 \| Dayton, Ohio, United States, 45424 Medical Facility \| Lima, Ohio, United States, 45805 Medical Facility \| Middleburg Heights, Ohio, United States, 44130 Medical Facility \| Tulsa, Oklahoma, United States, 74133 Medical Facility \| Eugene, Oregon, United States, 97404 Medical Facility \| Portland, Oregon, United States, 97202 Medical Facility \| 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 \| 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 Facility2 \| Chattanooga, Tennessee, United States, 37404 Medical Facility \| 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 \| Austin, Texas, United States, 78723 Medical Facility \| Carrollton, Texas, United States, 75007 Medical Facility2 \| Carrollton, Texas, United States, 75010 Medical Facility \| 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 Facility2 \| Houston, Texas, United States, 77036 Medical Facility \| Houston, Texas, United States, 77074 Medical Facility \| Kingwood, Texas, United States, 77339 Medical Facility \| League City, Texas, United States, 77573 Medical Facility2 \| McKinney, Texas, United States, 75069 Medical Facility \| McKinney, Texas, United States, 75070 Medical Facility2 \| Mesquite, Texas, United States, 75149 Medical Facility \| Mesquite, Texas, United States, 75149 Medical Facility \| Missouri City, Texas, United States, 77459 Medical Facility \| Pearland, Texas, United States, 77584 Medical Facility2 \| Plano, Texas, United States, 75024 Medical Facility \| Plano, Texas, United States, 75093 Medical Facility \| San Antonio, Texas, United States, 78215 Medical Facility 2 \| Sugar Land, Texas, United States, 77479 Medical Facility3 \| Sugar Land, Texas, United States, 77479 Medical Facility \| Sugar Land, Texas, United States, 77479 Medical Facility 2 \| Draper, Utah, United States, 84020 Medical Facility \| Draper, Utah, United States, 84020 Medical Facility \| Pleasant Grove, Utah, United States, 84062 Medical Facility \| Salt Lake City, Utah, United States, 84107 Medical Facility \| Falls Church, Virginia, United States, 22042 Medical Facility \| Manassas, Virginia, United States, 20110 Medical Facility \| Norfolk, Virginia, United States, 23502 Medical Facility \| Kingwood, West Virginia, United States, 26537 Medical Facility \| Morgantown, West Virginia, United States, 26505
Investigators

Study Documents (Full Text)

Documents Provided by Iterum Therapeutics, International Limited: Study Protocol December 5, 2022
Documents Provided by Iterum Therapeutics, International Limited: Statistical Analysis Plan January 10, 2024

More Information

Additional Relevant MeSH Terms

Infections
Communicable Diseases
Urinary Tract Infections
Cystitis
Disease Attributes
Pathologic Processes
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Urinary Bladder Diseases