BridgeMD
New treatment option for Pharmacokinetics After Oral Intake
Official title Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
ClinicalTrials.gov ID: NCT07092813
What this study is testing
What is sulopenem etzadroxil and probenecid?
sulopenem etzadroxil and probenecid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pharmacokinetics after oral intake.
Also referred to as Orlynvah.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- Patient's parent/both parents or guardian must provide written informed consent and a statement of assent from the adolescent patient (if required by...
- 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.
You likely can't join if
- Known renal insufficiency.
- Patient is unable to tolerate oral medications.
- Patient has presence of any of the following conditions:
- Endocarditis
- Meningitis
- Necrotizing fasciitis
See the full eligibility 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...
- 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...
- Patient must be willing to follow all study procedures.
- Known renal insufficiency.
- Patient is unable to tolerate oral medications.
- Patient has presence of any of the following conditions:
- Endocarditis
- Meningitis
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.