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

October 12, 2023 updated by: Iterum Therapeutics, International Limited

Expanded Access for the Use of Sulopenem Etzadroxil/Probenecid for the Treatment of Patients With Complicated Urinary Tract Infection Due to Quinolone-nonsusceptible Uropathogens

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).

Study Overview

Status

Available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iterum Therapeutics, International Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT001-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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