Status:
NO_LONGER_AVAILABLE
Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection
Lead Sponsor:
Iterum Therapeutics, International Limited
Conditions:
Complicated Urinary Tract Infection
Acute Pyelonephritis
Eligibility:
All Genders
18+ years
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 aft...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04682834
Last Update
August 14 2024
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