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

NCT04682834 | Unknown

• 1 other identifier: IT001-307
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Complicated Urinary Tract Infection; Acute Pyelonephritis

Interventions

Sulopenem Etzadroxil/Probenecid DRUG

Individual Patients

Also known as: Individual Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Iterum Therapeutics, International Limited: lead

MeSH Terms

Interventions

Probenecid

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 24, 2020
• Last Updated: August 14, 2024

Record last verified: 2024-08