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

Acute Pyelonephritis Clinical Trial

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04682834
• Other study ID #: IT001-307
• Status: Available

Study information

• Verified date: October 2023
• Source: Iterum Therapeutics, International Limited
• Contact: Senior Director, Clinical Development
• Phone: 8608762690
• Email: saronin[@]iterumtx.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pyelonephritis
• Communicable Diseases
• Complicated Urinary Tract Infection
• Infections
• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• Sulopenem Etzadroxil/Probenecid
Individual Patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iterum Therapeutics, International Limited