Is NCT07092813 recruiting in Little Rock, AR?

Yes, NCT07092813 is currently recruiting participants at its Little Rock, AR location. This pharmacokinetics after oral intake clinical trial is actively enrolling qualified participants.

Is participation in this Little Rock clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pharmacokinetics After Oral Intake Clinical Trial in Little Rock, AR

Q: How do I join the pharmacokinetics after oral intake clinical trial in Little Rock?

To join this clinical trial in Little Rock, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Pharmacokinetics After Oral Intake Study in Little Rock

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.

Sponsor: Iterum Therapeutics, International Limited

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Little Rock?

Yes, this clinical trial (NCT07092813) has an active research site in Little Rock, AR that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pharmacokinetics After Oral Intake Treatment Options in Little Rock, AR

If you're searching for pharmacokinetics after oral intake treatment options in Little Rock, AR, this clinical trial (NCT07092813) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Little Rock research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced pharmacokinetics after oral intake specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pharmacokinetics after oral intake clinical trials near you to find additional studies recruiting in your area.

Pharmacokinetics After Oral Intake Clinical Trial in Little Rock, AR

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