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
About this trial
This is an expanded access trial for Complicated Urinary Tract Infection
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04682834
First Posted
December 18, 2020
Last Updated
October 12, 2023
Sponsor
Iterum Therapeutics, International Limited
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
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Primary Completion Date
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Study Completion Date
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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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