NO_LONGER_AVAILABLENot Applicable

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

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

Trial details

NCT IDNCT04682834

SponsorIterum Therapeutics, International Limited

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Complicated Urinary Tract Infection trials