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

• Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis

• Registration Number: NCT04682834
• Lead Sponsor: Iterum Therapeutics, International Limited

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.

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified