Actively Recruiting
Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
Led by Iterum Therapeutics, International Limited · Updated on 2026-03-27
12
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or guardian must provide written consent and adolescent must assent if required
- Adolescent aged 12 to less than 18 years
- Diagnosed bacterial infection documented by treating physician
- Receiving appropriate antibiotic treatment for bacterial infection
- Sufficient venous access for blood sampling
- Postmenarchal females must have negative pregnancy test, not be breastfeeding
- Postmenarchal females and post-pubertal males must agree to use effective birth control during study and for 1 month after
- Willingness to follow all study procedures
You will not qualify if you...
- Known renal insufficiency
- Unable to tolerate oral medications
- Presence of endocarditis, meningitis, necrotizing fasciitis, or gas gangrene
- Signs of severe sepsis including shock unresponsive to fluids or coagulation abnormalities
- Active liver disease or significant liver dysfunction (except Gilbert's disease)
- Known neutropenia (absolute neutrophil count <500 cells/mm3)
- History of solid organ transplantation
- Any condition compromising patient safety as judged by investigator
- Known allergies to penicillin, carbapenems, cephalosporins, or probenecid
- History of hypersensitivity to study drug or similar compounds
- Involvement in study planning or conduct by patient or guardian
- Participation in another investigational drug study within 30 days or 5 half-lives
- Personal or family history of significant adverse drug reactions
- History or presence of gastrointestinal, liver, or kidney disease interfering with drug metabolism
- Treatment within 3 months with drugs known for hepatotoxicity
- Patient weighs less than 30 kg
- Patient is pregnant or lactating
- Received a carbapenem antibiotic as current standard care therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical facility
Little Rock, Arkansas, United States, 72205
Actively Recruiting
Research Team
S
Senior Vice President and Head of Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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