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

IT001-307

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).

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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

{'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1, 'expandedAccessTypes': {'individual': True}}

2023-10-13