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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

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:

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

undefined (undefined)

Primary Completion Date

undefined (undefined)

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

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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