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.
Patient's parent/both parents or guardian must provide written informed consent and a statement of assent from the adolescent patient (if required by Institutional Review Board [IRB] according to local regulations and guidelines) must be obtained prior to any study-related procedures. Communication should take place between the Investigator, parent(s)/guardian, and adolescent patient to confirm understanding and compliance with the study requirements.
Patient is male or female adolescent who are more than or equal to 12 and <18 years of age.
Patient has a diagnosis of a bacterial infection as documented by the treating physician
Patient will be receiving appropriate anti-infective treatment for a bacterial infection.
Known renal insufficiency.
Patient is unable to tolerate oral medications.
Endocarditis
Meningitis
Single group
sulopenem etzadroxil and probenecid
Drugsingle dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet.
Sulopenem plasma concentration after dose
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose
Probenecid plasma concentration after dose
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose
Sulopenem urine concentration after dose
Concentrations will be determined through analysis of urine samples collected 0-2, 2-4, 4-6, 6-8 and 8-12 hours after the dose
Probenecid urine concentration after dose
Concentrations will be determined through analysis of urine samples collected 0-2, 2-4, 4-6, 6-8 and 8-12 hours after dose
Number of participants with treatment emergent adverse events
Safety will be assessed by monitoring adverse events, physical examination, vital signs, and clinical laboratory tests
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