Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents

Inclusion criteria

• 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.
• Patient must have sufficient venous access to permit collection of PK samples and monitoring of laboratory safety variables.
• Female patients who are postmenarchal must not be pregnant, or breast feeding and must have a documented negative pregnancy test at Screening.
• Postmenarchal females and post-pubertal males must agree to use a highly effective method of birth control with partners of childbearing potential throughout the duration of the study and for 1 month following the last dose of study drug. NOTE: A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly. This includes sexual abstinence, implants, some intrauterine devices, or a vasectomized partner. A vasectomy or a condom used with a spermicide is a medically acceptable form of birth control for males.
• Patient must be willing to follow all study procedures.

Exclusion criteria

• Known renal insufficiency.
• Patient is unable to tolerate oral medications.
• Patient has presence of any of the following conditions:
• Endocarditis
• Necrotizing fasciitis
• Gas gangrene
• Patient has signs of severe sepsis including:
• Shock or profound hypotension that is not responsive to fluid challenge.
• Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time more than or equal to 2 × the upper limit of normal (ULN) or platelets \<50% of the lower limit of the normal.
• Patient has known active liver disease or hepatic dysfunction (except a confirmed diagnosis of Gilbert's disease) defined as non-transient elevations of aspartate aminotransferase or alanine aminotransferase level elevations more than or equal to 3 × the ULN or non-transient total bilirubin more than or equal to 2 × the ULN.
• Known neutropenia (absolute neutrophil count \<500 cells/mm3).
• Patient has history of solid organ transplantation reported at any time.
• Patient has any finding that, in the view of the Investigator, would compromise the patient's safety requirements.
• Patient has known allergies to penicillin, carbapenems, and/or cephalosporin antibiotics, known allergy to probenecid, or severe allergic reactions to any drug in the past.
• Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
• Patient or parent/legal guardian has involvement in the planning and/or conduct of this study (applies to both Iterum Therapeutics staff and/or staff at the study sites).
• Patient has participated in any other clinical study where an investigational product was ingested within 30 days or 5 half-lives of the drug (whichever is longer) prior to the current study.
• Patient has definite or suspected personal history or family history of clinically significant adverse drug reactions.
• Patient has history or presence of GI, hepatic, or renal disease, or other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Patient had treatment in the previous 3 months with any drug known to have a well-defined potential for hepatotoxicity (e.g., halothane).
• Patient weighs \<30 kg.
• Patient is pregnant or lactating.
• Patient has received a carbapenem as their standard of care therapy to treat the diagnosed bacterial infection.