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

Urinary Tract Infections Clinical Trial

— REASSURE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05584657
• Other study ID #: IT001-310
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2022
• Est. completion date: November 21, 2023

Study information

• Verified date: October 2023
• Source: Iterum Therapeutics, International Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

IT001-310 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2229
• Est. completion date: November 21, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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, ß-lactams or probenecid, as formulated with their excipients

Related Conditions & MeSH terms

• Communicable Diseases
• Cystitis
• Infections
• Urinary Tract Infections

Intervention

Drug:
• Sulopenem etzadroxil/probenecid
Oral sulopenem twice daily for 5 days
• Amoxicillin/clavulanate
Oral Augmentin twice daily for 5 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Iterum Therapeutics, International Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants with Overall Success	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
Primary	Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success	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
Primary	Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success	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
Secondary	Percentage of Modified Intent to Treat (MITT) Participants With Clinical Success	Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Clinical Success	Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Clinical Success	Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Clinical Success	Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Asymptomatic Bacteriuria	Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen)	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Asymptomatic Bacteriuria	Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Asymptomatic Bacteriuria	Asymptomatic Bacteriuria: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic Failure (persistence of the baseline pathogen	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Microbiologic Success	Microbiologic Success: Eradication of the Baseline Pathogen	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Microbiologic Success	Microbiologic Success: Eradication of the Baseline Pathogen	Day 12+/-1 day
Secondary	Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Microbiologic Success	Microbiologic Success: Eradication of the Baseline Pathogen	Day 12+/-1 day