Clinical trial NCT05584657: Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infections
Cystitis
Lead sponsor: Iterum Therapeutics, International Limited
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 2229
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall Success
timeFrame: Day 12+/-1 day
measure: Overall Success Susceptible Population
timeFrame: Day 12+/-1 day
Secondary outcomes:
measure: Clinical Success Modified Intent-to-treat Population
timeFrame: Day 12+/-1 day
measure: Clinical Success
timeFrame: Day 12+/-1 day
measure: Clinical Success Susceptible Population
timeFrame: Day 12+/-1 day
measure: Microbiologic Success
timeFrame: Day 12+/-1 day
measure: Microbiologic Success Susceptible Population
timeFrame: Day 12+/-1 day
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Medical Facility
state: Alabama
city: Saraland
country: United States
facility: Medical Facility
state: Alabama
city: Sheffield
country: United States
facility: Medical Facility
state: Alabama
city: Peoria
country: United States
facility: Medical Facility
state: Arizona
city: Phoenix
country: United States
facility: Medical Facility3
state: Arizona
city: Phoenix
country: United States
facility: Medical Facility
state: Arizona
city: Phoenix
country: United States
facility: Medical Facility2
state: Arizona
city: Tucson
country: United States
facility: Medical Facility
state: Arizona
city: Hot Springs
country: United States
facility: Medical Facility2
state: Arkansas
city: Hot Springs
country: United States
facility: Medical Facility
state: Arkansas
city: Bakersfield
country: United States
facility: Medical Facility
state: California
city: Chula Vista
country: United States
facility: Medical Facility
state: California
city: Fullerton
country: United States
facility: Medical Facility
state: California
city: Garden Grove
country: United States
facility: Medical Facility
state: California
city: Huntington Beach
country: United States
facility: Medical Facility
state: California
city: Huntington Park
country: United States
facility: Medical Facility 2
state: California
city: Huntington Park
country: United States
facility: Medical Facility
state: California
city: Irvine
country: United States
facility: Medical Facility
state: California
city: La Mesa
country: United States
facility: Medical Facility
state: California
city: Lancaster
country: United States
facility: Medical Facility
state: California
city: Lomita
country: United States
facility: Medical Facility
state: California
city: Los Angeles
country: United States
facility: Medical Facility2
state: California
city: Los Angeles
country: United States
facility: Medical Facility
state: California
city: Pomona
country: United States
facility: Medical Facility
state: California
city: Sacramento
country: United States
facility: Medical Facility
state: California
city: San Diego
country: United States
facility: Medical Facility
state: California
city: Upland
country: United States
facility: Medical Facility
state: California
city: Victorville
country: United States
facility: Medical Facility
state: California
city: Grand Junction
country: United States
facility: Medical Facility
state: Colorado
city: Lakewood
country: United States
facility: Medical Facility
state: Colorado
city: Aventura
country: United States
facility: Medical Facility
state: Florida
city: Boynton Beach
country: United States
facility: Medical Facility
state: Florida
city: Cape Coral
country: United States
facility: Medical Facility
state: Florida
city: Doral
country: United States
facility: Medical Facility
state: Florida
city: Edgewater
country: United States
facility: Medical Facility
state: Florida
city: Hialeah
country: United States
facility: Medical Facility
state: Florida
city: Hollywood
country: United States
facility: Medical Facility
state: Florida
city: Homestead
country: United States
facility: Medical Facility
state: Florida
city: Lake Worth
country: United States
facility: Medical Facility
state: Florida
city: Lake Worth
country: United States
facility: Medical Facility2
state: Florida
city: Leesburg
country: United States
facility: Medical Facility
state: Florida
city: Miami Beach
country: United States
facility: Medical Facility
state: Florida
city: Miami Gardens
country: United States
facility: Medical Facility
state: Florida
city: Miami Lakes
country: United States
facility: Medical Facility2
state: Florida
city: Miami Lakes
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility3
state: Florida
city: Miami
country: United States
facility: Medical Facility2
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility9
state: Florida
city: Miami
country: United States
facility: Medical Facility5
state: Florida
city: Miami
country: United States
facility: Medical Facility8
state: Florida
city: Miami
country: United States
facility: Medical Facility6
state: Florida
city: Miami
country: United States
facility: Medical Facility7
state: Florida
city: Miami
country: United States
facility: Medical Facility4
state: Florida
city: Orlando
country: United States
facility: Medical Facility
state: Florida
city: Orlando
country: United States
facility: Medical Facility2
state: Florida
city: Ormond Beach
country: United States
facility: Medical Facility
state: Florida
city: Pompano Beach
country: United States
facility: Medical Facility
state: Florida
city: Sweetwater
country: United States
facility: Medical Facility
state: Florida
city: Tamarac
country: United States
facility: Medical Facility
state: Florida
city: Tampa
country: United States
facility: Medical Facility
state: Florida
city: Tampa
country: United States
facility: Medical Facility3
state: Florida
city: Tampa
country: United States
facility: Medical Facility4
state: Florida
city: Tampa
country: United States
facility: Medical Facility2
state: Florida
city: Tampa
country: United States
facility: Medical Facility5
state: Florida
city: Winter Haven
country: United States
facility: Medical Facility
state: Florida
city: Atlanta
country: United States
facility: Medical Facility3
state: Georgia
city: Atlanta
country: United States
facility: Medical Facility2
state: Georgia
city: Atlanta
country: United States
facility: Medical Facility
state: Georgia
city: Decatur
country: United States
facility: Medical Facility
state: Georgia
city: Lawrenceville
country: United States
facility: Medical Facility
state: Georgia
city: Union City
country: United States
facility: Medical Facility
state: Georgia
city: Woodstock
country: United States
facility: Medical Facility
state: Georgia
city: Blackfoot
country: United States
facility: Medical Facility
state: Idaho
city: Idaho Falls
country: United States
facility: Medical Facility2
state: Idaho
city: Idaho Falls
country: United States
facility: Medical Facility
state: Idaho
city: Chicago
country: United States
facility: Medical Facility
state: Illinois
city: Eunice
country: United States
facility: Medical Facility
state: Louisiana
city: Mandeville
country: United States
facility: Medical Facility
state: Louisiana
city: Marrero
country: United States
facility: Medical Facility
state: Louisiana
city: Metairie
country: United States
facility: Medical Facility
state: Louisiana
city: New Orleans
country: United States
facility: Medical Facility
state: Louisiana
city: New Orleans
country: United States
facility: Medical Facility2
state: Louisiana
city: Prairieville
country: United States
facility: Medical Facility
state: Louisiana
city: Shreveport
country: United States
facility: Medical Facility
state: Louisiana
city: Columbia
country: United States
facility: Medical Facility
state: Maryland
city: Oxon Hill
country: United States
facility: Medical Facility
state: Maryland
city: Towson
country: United States
facility: Medical Facility
state: Maryland
city: Fayette
country: United States
facility: Medical Facility
state: Mississippi
city: Gulfport
country: United States
facility: Medical Facility
state: Mississippi
city: Jackson
country: United States
facility: Medical Facility
state: Mississippi
city: Ridgeland
country: United States
facility: Medical Facility
state: Mississippi
city: Great Falls
country: United States
facility: Medical Facility
state: Montana
city: Kalispell
country: United States
facility: Medical Facility
state: Montana
city: Missoula
country: United States
facility: Medical Facility
state: Montana
city: Las Vegas
country: United States
facility: Medical Facility2
state: Nevada
city: Las Vegas
country: United States
facility: Medical Facility
state: Nevada
city: Albuquerque
country: United States
facility: Medical Facility2
state: New Mexico
city: Albuquerque
country: United States
facility: Medical Facility
state: New Mexico
city: Bronx
country: United States
facility: Medical Facility
state: New York
city: Brooklyn
country: United States
facility: Medical Facility
state: New York
city: Brooklyn
country: United States
facility: Medical Facility2
state: New York
city: Garden City
country: United States
facility: Medical Facility
state: New York
city: Schenectady
country: United States
facility: Medical Facility
state: New York
city: Charlotte
country: United States
facility: Medical Facility
state: North Carolina
city: Greensboro
country: United States
facility: Medical Facility
state: North Carolina
city: New Bern
country: United States
facility: Medical Facility
state: North Carolina
city: Winston-Salem
country: United States
facility: Medical Facility
state: North Carolina
city: Cincinnati
country: United States
facility: Medical Facility
state: Ohio
city: Columbus
country: United States
facility: Medical Facility2
state: Ohio
city: Columbus
country: United States
facility: Medical Facility
state: Ohio
city: Dayton
country: United States
facility: Medical Facility
state: Ohio
city: Dayton
country: United States
facility: Medical Facility2
state: Ohio
city: Lima
country: United States
facility: Medical Facility
state: Ohio
city: Middleburg Heights
country: United States
facility: Medical Facility
state: Ohio
city: Tulsa
country: United States
facility: Medical Facility
state: Oklahoma
city: Eugene
country: United States
facility: Medical Facility
state: Oregon
city: Portland
country: United States
facility: Medical Facility
state: Oregon
city: Beaver
country: United States
facility: Medical Facility
state: Pennsylvania
city: Scottdale
country: United States
facility: Medical Facility
state: Pennsylvania
city: Smithfield
country: United States
facility: Medical Facility
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Medical Facility
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Facility
state: South Carolina
city: Easley
country: United States
facility: Medical Facility
state: South Carolina
city: Greenville
country: United States
facility: Medical Facility
state: South Carolina
city: Lancaster
country: United States
facility: Medical Facility
state: South Carolina
city: Myrtle Beach
country: United States
facility: Medical Facility
state: South Carolina
city: Powdersville
country: United States
facility: Medical Facility
state: South Carolina
city: Seneca
country: United States
facility: Medical Facility
state: South Carolina
city: Summerville
country: United States
facility: Medical Facility
state: South Carolina
city: Chattanooga
country: United States
facility: Medical Facility2
state: Tennessee
city: Chattanooga
country: United States
facility: Medical Facility
state: Tennessee
city: Hendersonville
country: United States
facility: Medical Facility
state: Tennessee
city: Memphis
country: United States
facility: Medical Facility
state: Tennessee
city: Nashville
country: United States
facility: Medical Facility
state: Tennessee
city: Austin
country: United States
facility: Medical Facility
state: Texas
city: Carrollton
country: United States
facility: Medical Facility
state: Texas
city: Carrollton
country: United States
facility: Medical Facility2
state: Texas
city: Corpus Christi
country: United States
facility: Medical Facility
state: Texas
city: Dallas
country: United States
facility: Medical Facility
state: Texas
city: Frisco
country: United States
facility: Medical Facility
state: Texas
city: Georgetown
country: United States
facility: Medical Facility
state: Texas
city: Houston
country: United States
facility: Medical Facility2
state: Texas
city: Houston
country: United States
facility: Medical Facility
state: Texas
city: Kingwood
country: United States
facility: Medical Facility
state: Texas
city: League City
country: United States
facility: Medical Facility
state: Texas
city: McKinney
country: United States
facility: Medical Facility2
state: Texas
city: McKinney
country: United States
facility: Medical Facility
state: Texas
city: Mesquite
country: United States
facility: Medical Facility2
state: Texas
city: Mesquite
country: United States
facility: Medical Facility
state: Texas
city: Missouri City
country: United States
facility: Medical Facility
state: Texas
city: Pearland
country: United States
facility: Medical Facility
state: Texas
city: Plano
country: United States
facility: Medical Facility2
state: Texas
city: Plano
country: United States
facility: Medical Facility
state: Texas
city: San Antonio
country: United States
facility: Medical Facility
state: Texas
city: Sugar Land
country: United States
facility: Medical Facility 2
state: Texas
city: Sugar Land
country: United States
facility: Medical Facility3
state: Texas
city: Sugar Land
country: United States
facility: Medical Facility
state: Texas
city: Draper
country: United States
facility: Medical Facility 2
state: Utah
city: Draper
country: United States
facility: Medical Facility
state: Utah
city: Pleasant Grove
country: United States
facility: Medical Facility
state: Utah
city: Salt Lake City
country: United States
facility: Medical Facility
state: Utah
city: Falls Church
country: United States
facility: Medical Facility
state: Virginia
city: Manassas
country: United States
facility: Medical Facility
state: Virginia
city: Norfolk
country: United States
facility: Medical Facility
state: Virginia
city: Kingwood
country: United States
facility: Medical Facility
state: West Virginia
city: Morgantown
country: United States
facility: Medical Facility
state: West Virginia
Study officials:
affiliation: Iterum Therapeutics
name: Sailaja Puttagunta, MD
role: STUDY_DIRECTOR
References: