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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified September 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 13, 2022
First Posted
October 17, 2022
Results First Posted
October 29, 2024
Last Update Posted
November 19, 2024
Last Verified
September 2024

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

History of Changes

Study Details

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 DiseaseIntervention/Treatment
Urinary Tract InfectionsCystitis
Drug: Sulopenem etzadroxil/probenecidDrug: Amoxicillin/clavulanate

Study Design

Study TypeInterventional
Actual Enrollment2229 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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 DateOctober 17, 2022
Actual Primary Completion DateNovember 2, 2023
Actual Study Completion DateNovember 20, 2023

Groups and Cohorts

Group/CohortIntervention/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
Oral Augmentin twice daily for 5 days

Outcome Measures

Primary Outcome Measures
  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)
  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)
Secondary Outcome Measures
  1. Clinical Success Modified Intent-to-treat Population
    Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
  2. Clinical Success
    Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
  3. Clinical Success Susceptible Population
    Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
  4. Microbiologic Success
    Eradication of the Baseline Pathogen
  5. Microbiologic Success Susceptible Population
    Microbiologic Success: Eradication of the Baseline Pathogen

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
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 CollaboratorsIterum Therapeutics, International Limited
Locations
Medical Facility | Cullman Alabama, United States, 35055Medical Facility | Saraland Alabama, United States, 36571Medical Facility | Sheffield Alabama, United States, 35660Medical Facility | Peoria Arizona, United States, 85381Medical Facility3 | Phoenix Arizona, United States, 85031Medical Facility | Phoenix Arizona, United States, 85032Medical Facility2 | Phoenix Arizona, United States, 85051Medical Facility | Tucson Arizona, United States, 85715Medical Facility2 | Hot Springs Arkansas, United States, 71901Medical Facility | Hot Springs Arkansas, United States, 71913Medical Facility | Bakersfield California, United States, 93309Medical Facility | Chula Vista California, United States, 91911Medical Facility | Fullerton California, United States, 92835Medical Facility | Garden Grove California, United States, 92844Medical Facility | Huntington Beach California, United States, 92648Medical Facility 2 | Huntington Park California, United States, 90255Medical Facility | Huntington Park California, United States, 90255Medical Facility | Irvine California, United States, 92614Medical Facility | La Mesa California, United States, 91942Medical Facility | Lancaster California, United States, 93534Medical Facility | Lomita California, United States, 90717Medical Facility2 | Los Angeles California, United States, 90017Medical Facility | Los Angeles California, United States, 90057Medical Facility | Pomona California, United States, 91768Medical Facility | Sacramento California, United States, 95821Medical Facility | San Diego California, United States, 92111Medical Facility | Upland California, United States, 91786Medical Facility | Victorville California, United States, 92395Medical Facility | Grand Junction Colorado, United States, 81501Medical Facility | Lakewood Colorado, United States, 80228Medical Facility | Aventura Florida, United States, 33180Medical Facility | Boynton Beach Florida, United States, 33435Medical Facility | Cape Coral Florida, United States, 33909Medical Facility | Doral Florida, United States, 33166Medical Facility | Edgewater Florida, United States, 32132Medical Facility | Hialeah Florida, United States, 33016Medical Facility | Hollywood Florida, United States, 33024Medical Facility | Homestead Florida, United States, 33032Medical Facility | Lake Worth Florida, United States, 33460Medical Facility2 | Lake Worth Florida, United States, 33461Medical Facility | Leesburg Florida, United States, 34748Medical Facility3 | Miami Florida, United States, 33126Medical Facility2 | Miami Florida, United States, 33135Medical Facility | Miami Florida, United States, 33165Medical Facility9 | Miami Florida, United States, 33173Medical Facility5 | Miami Florida, United States, 33175Medical Facility8 | Miami Florida, United States, 33176Medical Facility6 | Miami Florida, United States, 33179Medical Facility7 | Miami Florida, United States, 33184Medical Facility4 | Miami Florida, United States, 33186Medical Facility | Miami Beach Florida, United States, 33140Medical Facility | Miami Gardens Florida, United States, 33056Medical Facility2 | Miami Lakes Florida, United States, 33016Medical Facility | Miami Lakes Florida, United States, 33317Medical Facility | Orlando Florida, United States, 32806Medical Facility2 | Orlando Florida, United States, 32812Medical Facility | Ormond Beach Florida, United States, 32174Medical Facility | Pompano Beach Florida, United States, 33060Medical Facility | Sweetwater Florida, United States, 33172Medical Facility | Tamarac Florida, United States, 33321Medical Facility | Tampa Florida, United States, 33603Medical Facility3 | Tampa Florida, United States, 33607Medical Facility4 | Tampa Florida, United States, 33607Medical Facility2 | Tampa Florida, United States, 33614Medical Facility5 | Tampa Florida, United States, 33634Medical Facility | Winter Haven Florida, United States, 33880Medical Facility3 | Atlanta Georgia, United States, 30309Medical Facility2 | Atlanta Georgia, United States, 30329Medical Facility | Atlanta Georgia, United States, 30342Medical Facility | Decatur Georgia, United States, 30034Medical Facility | Lawrenceville Georgia, United States, 30046Medical Facility | Union City Georgia, United States, 30291Medical Facility | Woodstock Georgia, United States, 30189Medical Facility | Blackfoot Idaho, United States, 83221Medical Facility2 | Idaho Falls Idaho, United States, 08340Medical Facility | Idaho Falls Idaho, United States, 83404Medical Facility | Chicago Illinois, United States, 60643Medical Facility | Eunice Louisiana, United States, 70535Medical Facility | Mandeville Louisiana, United States, 70471Medical Facility | Marrero Louisiana, United States, 70072Medical Facility | Metairie Louisiana, United States, 70001Medical Facility | New Orleans Louisiana, United States, 70124Medical Facility2 | New Orleans Louisiana, United States, 70127Medical Facility | Prairieville Louisiana, United States, 70769Medical Facility | Shreveport Louisiana, United States, 71106Medical Facility | Columbia Maryland, United States, 21045Medical Facility | Oxon Hill Maryland, United States, 20745Medical Facility | Towson Maryland, United States, 21204Medical Facility | Fayette Mississippi, United States, 39069Medical Facility | Gulfport Mississippi, United States, 39503Medical Facility | Jackson Mississippi, United States, 39202Medical Facility | Ridgeland Mississippi, United States, 39157Medical Facility | Great Falls Montana, United States, 59405Medical Facility | Kalispell Montana, United States, 59901Medical Facility | Missoula Montana, United States, 59804Medical Facility2 | Las Vegas Nevada, United States, 89113Medical Facility | Las Vegas Nevada, United States, 89121Medical Facility2 | Albuquerque New Mexico, United States, 87102Medical Facility | Albuquerque New Mexico, United States, 87109Medical Facility | Brooklyn New York, United States, 11215Medical Facility2 | Brooklyn New York, United States, 11229Medical Facility | Garden City New York, United States, 11530Medical Facility | Schenectady New York, United States, 12304Medical Facility | The Bronx New York, United States, 10456Medical Facility | Charlotte North Carolina, United States, 28277Medical Facility | Greensboro North Carolina, United States, 27405Medical Facility | New Bern North Carolina, United States, 28562Medical Facility | Winston-Salem North Carolina, United States, 27103Medical Facility | Cincinnati Ohio, United States, 45219Medical Facility2 | Columbus Ohio, United States, 43213Medical Facility | Columbus Ohio, United States, 43228Medical Facility | Dayton Ohio, United States, 45409Medical Facility2 | Dayton Ohio, United States, 45424Medical Facility | Lima Ohio, United States, 45805Medical Facility | Middleburg Heights Ohio, United States, 44130Medical Facility | Tulsa Oklahoma, United States, 74133Medical Facility | Eugene Oregon, United States, 97404Medical Facility | Portland Oregon, United States, 97202Medical Facility | Beaver Pennsylvania, United States, 15009Medical Facility | Scottdale Pennsylvania, United States, 15683Medical Facility | Smithfield Pennsylvania, United States, 15478Medical Facility | Upper Saint Clair Pennsylvania, United States, 15241Medical Facility | Charleston South Carolina, United States, 29414Medical Facility | Easley South Carolina, United States, 29640Medical Facility | Greenville South Carolina, United States, 29607Medical Facility | Lancaster South Carolina, United States, 29720Medical Facility | Myrtle Beach South Carolina, United States, 29572Medical Facility | Powdersville South Carolina, United States, 29611Medical Facility | Seneca South Carolina, United States, 29678Medical Facility | Summerville South Carolina, United States, 29485Medical Facility2 | Chattanooga Tennessee, United States, 37404Medical Facility | Chattanooga Tennessee, United States, 37421Medical Facility | Hendersonville Tennessee, United States, 37075Medical Facility | Memphis Tennessee, United States, 38120Medical Facility | Nashville Tennessee, United States, 37209Medical Facility | Austin Texas, United States, 78723Medical Facility | Carrollton Texas, United States, 75007Medical Facility2 | Carrollton Texas, United States, 75010Medical Facility | Corpus Christi Texas, United States, 78404Medical Facility | Dallas Texas, United States, 75209Medical Facility | Frisco Texas, United States, 75033Medical Facility | Georgetown Texas, United States, 79628Medical Facility2 | Houston Texas, United States, 77036Medical Facility | Houston Texas, United States, 77074Medical Facility | Kingwood Texas, United States, 77339Medical Facility | League City Texas, United States, 77573Medical Facility2 | McKinney Texas, United States, 75069Medical Facility | McKinney Texas, United States, 75070Medical Facility2 | Mesquite Texas, United States, 75149Medical Facility | Mesquite Texas, United States, 75149Medical Facility | Missouri City Texas, United States, 77459Medical Facility | Pearland Texas, United States, 77584Medical Facility2 | Plano Texas, United States, 75024Medical Facility | Plano Texas, United States, 75093Medical Facility | San Antonio Texas, United States, 78215Medical Facility 2 | Sugar Land Texas, United States, 77479Medical Facility3 | Sugar Land Texas, United States, 77479Medical Facility | Sugar Land Texas, United States, 77479Medical Facility 2 | Draper Utah, United States, 84020Medical Facility | Draper Utah, United States, 84020Medical Facility | Pleasant Grove Utah, United States, 84062Medical Facility | Salt Lake City Utah, United States, 84107Medical Facility | Falls Church Virginia, United States, 22042Medical Facility | Manassas Virginia, United States, 20110Medical Facility | Norfolk Virginia, United States, 23502Medical Facility | Kingwood West Virginia, United States, 26537Medical Facility | Morgantown West Virginia, United States, 26505
Investigators
Study Director: Sailaja Puttagunta, MD, Iterum Therapeutics
Study Documents (Full Text)
Documents provided by Iterum Therapeutics, International LimitedStudy Protocol  December 4, 2022Documents provided by Iterum Therapeutics, International LimitedStatistical Analysis Plan  January 9, 2024