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

Sponsor
Iterum Therapeutics, International Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05584657
Collaborator
(none)
1,966
Enrollment
76
Locations
2
Arms
17.4
Anticipated Duration (Months)
25.9
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1966 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Actual Study Start Date :
Oct 18, 2022
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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
Other Names:
  • Oral sulopenem

    		•
    Active Comparator: Amoxicillin/clavulanate

    Amoxicillin/clavulanate PO twice daily for 5 days

    Drug: Amoxicillin/clavulanate
    Oral Augmentin twice daily for 5 days
    Other Names:
  • Augmentin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants with Overall Success [Day 12+/-1 day]

      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. Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success [Day 12+/-1 day]

      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)

    3. Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success [Day 12+/-1 day]

      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)

    Secondary Outcome Measures

    1. Percentage of Modified Intent to Treat (MITT) Participants With Clinical Success [Day 12+/-1 day]

      Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms

    2. Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Clinical Success [Day 12+/-1 day]

      Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms

    3. Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Clinical Success [Day 12+/-1 day]

      Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms

    4. Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Clinical Success [Day 12+/-1 day]

      Clinical Success: Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms

    5. Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Asymptomatic Bacteriuria [Day 12+/-1 day]

      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)

    6. Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Asymptomatic Bacteriuria [Day 12+/-1 day]

      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

    7. Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Asymptomatic Bacteriuria [Day 12+/-1 day]

      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

    8. Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Microbiologic Success [Day 12+/-1 day]

      Microbiologic Success: Eradication of the Baseline Pathogen

    9. Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Microbiologic Success [Day 12+/-1 day]

      Microbiologic Success: Eradication of the Baseline Pathogen

    10. Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Microbiologic Success [Day 12+/-1 day]

      Microbiologic Success: Eradication of the Baseline Pathogen

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Medical Facility Cullman Alabama United States 35055
    2 Medical Facility Phoenix Arizona United States 85032
    3 Medical Facility Hot Springs Arkansas United States 71901
    4 Medical Facility Hot Springs Arkansas United States 71913
    5 Medical Facility Bakersfield California United States 93309
    6 Medical Facility Chula Vista California United States 91911
    7 Medical Facility Garden Grove California United States 92844
    8 Medical Facility 2 Huntington Park California United States 90255
    9 Medical Facility Huntington Park California United States 90255
    10 Medical Facility Irvine California United States 92614
    11 Medical Facility La Mesa California United States 91942
    12 Medical Facility Lomita California United States 90717
    13 Medical Facility Los Angeles California United States 90057
    14 Medical Facility Pomona California United States 91768
    15 Medical Facility Sacramento California United States 95821
    16 Medical Facility San Diego California United States 92111
    17 Medical Facility Upland California United States 91786
    18 Medical Facility Victorville California United States 92395
    19 Medical Facility Grand Junction Colorado United States 81501
    20 Medical Facility Atlanta Georgia United States 30329
    21 Medical Facility Atlanta Georgia United States 30342
    22 Medical Facility Decatur Georgia United States 30034
    23 Medical Facility Lawrenceville Georgia United States 30046
    24 Medical Facility Union City Georgia United States 30291
    25 Medical Facility Idaho Falls Idaho United States 08340
    26 Medical Facility Idaho Falls Idaho United States 83404
    27 Medical Facility Mandeville Louisiana United States 70471
    28 Medical Facility Metairie Louisiana United States 70001
    29 Medical Facility New Orleans Louisiana United States 70124
    30 Medical Facility Prairieville Louisiana United States 70769
    31 Medical Facility Oxon Hill Maryland United States 20745
    32 Medical Facility Towson Maryland United States 21204
    33 Medical Facility Fayette Mississippi United States 39069
    34 Medical Facility Gulfport Mississippi United States 39503
    35 Medical Facility Jackson Mississippi United States 39202
    36 Medical Facility Ridgeland Mississippi United States 39157
    37 Medical Facility Great Falls Montana United States 59405
    38 Medical Facility Kalispell Montana United States 59901
    39 Medical Facility Missoula Montana United States 59804
    40 Medical Facility Las Vegas Nevada United States 89113
    41 Medical Facility Las Vegas Nevada United States 89121
    42 Medical Facility Albuquerque New Mexico United States 87109
    43 Medical Facility Bronx New York United States 10456
    44 Medical Facility Brooklyn New York United States 11215
    45 Medical Facility Garden City New York United States 11530
    46 Medical Facility Greensboro North Carolina United States 27405
    47 Medical Facility New Bern North Carolina United States 28562
    48 Medical Facility Winston-Salem North Carolina United States 27103
    49 Medical Facility Cincinnati Ohio United States 45219
    50 Medical Facility Dayton Ohio United States 45409
    51 Medical Facility Middleburg Heights Ohio United States 44130
    52 Medical Facility Tulsa Oklahoma United States 74133
    53 Medical Facility Portland Oregon United States 97202
    54 Medical Facility Upper Saint Clair Pennsylvania United States 15241
    55 Medical Facility Charleston South Carolina United States 29414
    56 Medical Facility Easley South Carolina United States 29640
    57 Medical Facility Greenville South Carolina United States 29607
    58 Medical Facility Powdersville South Carolina United States 29611
    59 Medical Facility Seneca South Carolina United States 29678
    60 Medical Facility Summerville South Carolina United States 29485
    61 Medical Facility Chattanooga Tennessee United States 37421
    62 Medical Facility Hendersonville Tennessee United States 37075
    63 Medical Facility Memphis Tennessee United States 38120
    64 Medical Facility Nashville Tennessee United States 37209
    65 Medical Facility Corpus Christi Texas United States 78404
    66 Medical Facility Georgetown Texas United States 79628
    67 Medical Facility Houston Texas United States 77074
    68 Medical Facility League City Texas United States 77573
    69 Medical Facility McKinney Texas United States 75070
    70 Medical Facility Pearland Texas United States 77584
    71 Medical Facility Plano Texas United States 75093
    72 Medical Facility 2 Sugar Land Texas United States 77479
    73 Medical Facility Sugar Land Texas United States 77479
    74 Medical Facility Draper Utah United States 84020
    75 Medical Facility Salt Lake City Utah United States 84107
    76 Medical Facility Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • Iterum Therapeutics, International Limited

    Investigators

    • Study Director: Sailaja Puttagunta, MD, Iterum Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Iterum Therapeutics, International Limited
    ClinicalTrials.gov Identifier:
    NCT05584657
    Other Study ID Numbers:
    • IT001-310
    First Posted:
    Oct 18, 2022
    Last Update Posted:
    Jan 19, 2023
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections
    Cystitis
    Amoxicillin
    Clavulanic Acid
    Clavulanic Acids
    Amoxicillin-Potassium Clavulanate Combination
    Lactams
    Probenecid

    Study Results

    No Results Posted as of Jan 19, 2023