Urinary Tract Infections Clinical Trial
— REASSUREOfficial 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
Verified date | October 2023 |
Source | Iterum Therapeutics, International Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
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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 |
Lead Sponsor | Collaborator |
---|---|
Iterum Therapeutics, International Limited |
United States,
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 |
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