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Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection

Primary Purpose

Complicated Urinary Tract Infection, Acute Pyelonephritis

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Sulopenem Etzadroxil/Probenecid
Sponsored by
Iterum Therapeutics, International Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Complicated Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  1. Adults ≥18 years of age with complicated urinary tract infection due to a quinolone-nonsusceptible uropathogen
  2. Patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures.
  3. Clinically documented pyelonephritis or complicated urinary tract infection for which at least one dose of effective intravenous antibiotics has been received.

Exclusion Criteria:

  1. Patients who require concomitant administration of valproic acid
  2. Patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs or probenecid.
  3. Patients with known uric acid kidney stones
  4. Patients requiring concomitant use of ketorolac tromethamine or ketoprofen

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 18, 2020
    Last Updated
    October 12, 2023
    Sponsor
    Iterum Therapeutics, International Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04682834
    Brief Title
    Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection
    Official Title
    Expanded Access for the Use of Sulopenem Etzadroxil/Probenecid for the Treatment of Patients With Complicated Urinary Tract Infection Due to Quinolone-nonsusceptible Uropathogens
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Iterum Therapeutics, International Limited

    4. Oversight

    5. Study Description

    Brief Summary
    Sulopenem etzadroxil/probenecid is available to clinicians through an Expanded Access Program for the treatment of complicated urinary tract infections due to quinolone nonsusceptible uropathogens after an initial course of effective intravenous therapy. The investigational product may be requested by sending an email to the Sponsor (EAProgram@iterumtx.com), as listed on the Reagan Udall EAP Navigator website (https://navigator.reaganudall.org/company-directory/i).
    Detailed Description
    This Expanded Access Program will allow clinicians to use sulopenem etzadroxil/probenecid for the treatment of patients with serious or immediately life-threatening complicated urinary tract infection due to quinolone-nonsusceptible uropathogens where there are no satisfactory oral alternatives to use as step-down therapy after receiving an initial course of effective intravenous therapy. The recommended dose of sulopenem etzadroxil/probenecid 500 mg/ 500 mg is one bilayer tablet orally twice daily, taken with food whenever possible. No dose adjustment is required for patients with renal impairment. Duration of therapy will be at the discretion of the prescribing clinician, depending on the type of infection being treated and the response to therapy, and is expected to be less than ten days total.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complicated Urinary Tract Infection, Acute Pyelonephritis

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Sulopenem Etzadroxil/Probenecid
    Other Intervention Name(s)
    Individual Patients
    Intervention Description
    Individual Patients

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Adults ≥18 years of age with complicated urinary tract infection due to a quinolone-nonsusceptible uropathogen Patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures. Clinically documented pyelonephritis or complicated urinary tract infection for which at least one dose of effective intravenous antibiotics has been received. Exclusion Criteria: Patients who require concomitant administration of valproic acid Patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs or probenecid. Patients with known uric acid kidney stones Patients requiring concomitant use of ketorolac tromethamine or ketoprofen
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Senior Director, Clinical Development
    Phone
    8608762690
    Email
    saronin@iterumtx.com

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection

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