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Trial record 1 of 6 for:    iterum | Urinary Tract Infections
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Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women (REASSURE)

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ClinicalTrials.gov Identifier: NCT05584657
Recruitment Status : Recruiting
First Posted : October 18, 2022
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Iterum Therapeutics, International Limited

Study Description
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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
Urinary Tract Infections Cystitis Drug: Sulopenem etzadroxil/probenecid Drug: Amoxicillin/clavulanate Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 18, 2022
Estimated Primary Completion Date : March 15, 2024
Estimated Study Completion Date : March 31, 2024

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Arms and Interventions
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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 Name: 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 Name: Augmentin


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants with Overall Success [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 12+/-1 day ]
    Microbiologic Success: Eradication of the Baseline Pathogen


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05584657


Contacts
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Contact: Steven Aronin, MD 860-661-4035 saronin@iterumtx.com

Locations
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Sponsors and Collaborators
Iterum Therapeutics, International Limited
Investigators
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Study Director: Sailaja Puttagunta, MD Iterum Therapeutics
More Information
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Responsible Party: Iterum Therapeutics, International Limited
ClinicalTrials.gov Identifier: NCT05584657    
Other Study ID Numbers: IT001-310
First Posted: October 18, 2022    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Urinary Bladder Diseases
Cystitis
Disease Attributes
Pathologic Processes
Urologic Diseases
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
 Lactams
Probenecid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents