Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents

The goal of this clinical trial is to evaluate the use of sulopenem etzadroxil plus probenecid in adolescent patients being treated for bacterial infection. The main questions it aims to answer are: Is sulopenem etzadroxil plus probenecid safe to use in adolescents? Is sulopenem etzadroxil plus probenecid tolerable when used in adolescents? When ingested, what does the adolescent body do to sulopenem etzadroxil plus probenecid, in terms of the movement of the drug into, through, and out of the body. Participants will receive standard of care antibiotics for their bacterial infection as directed by their physician. In addition, participants will be asked to take a single oral dose of sulopenem etzadroxil plus probenecid. Blood samples will be collected before the dose of sulopenem etzadroxil plus probenecid, as well as at specified timepoints after the dose. Likewise, urine will be collected at specified time periods after the dose. During the course of the study, data will be collected from participants including vital sign measurements, physical examination findings, and the details of any adverse events that are reported.

NCT Number	NCT07092813
Lead Sponsor	Iterum Therapeutics, International Limited
Conditions	Pharmacokinetics After Oral Intake
Enrollment	12 participants
Start Date	2026-04
Primary Completion	2026-10 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-27