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WITHDRAWNPHASE1

Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents

A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem and Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection

NCT04700787•Iterum Therapeutics, International Limited

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Hospitalized patients who are 12-18 years of age and who are receiving background antibiotic treatment for uncomplicated urinary tract infection, complicated urinary tract infection, acute pyelonephritis, or complicated intraabdominal infection, and who meet eligibility requirements will receive a single 1000 mg IV dose of sulopenem on Day 1. The following day, patients will receive a single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. During treatment, pharmacokinetic samples will be collected and patients will be monitored for safety and tolerability.

Eligibility

Age

12 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Patient is male or female adolescent who are ≥12 and \<18 years of age.
•3. Patient has a diagnosis of uUTI, cUTI, AP, or cIAI as documented by the treating physician
•4. Patient will be hospitalized for urinary tract infection, acute pyelonephritis, or complicated intraabdominal infection for at least 48 hours and be receiving appropriate anti-infective treatment.
•5. Patient must have sufficient venous access to permit administration of study drug, collection of PK samples, and monitoring of laboratory safety variables.
•6. Female patients who are post-menarche must not be pregnant or breast feeding and must have a documented negative serum pregnancy test at Screening.
•7. Post-menarchal 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.
•8. Patient must be willing to follow all study procedures.

Exclusion Criteria

•1. Patient has creatinine clearance \<90 mL/min using the Cockcroft-Gault formula.
•2. Patient is unable to tolerate oral medications.
•3. Patient has presence of Endocarditis, Meningitis, Necrotizing fasciitis, or Gas gangrene
•4. Patient has signs of severe sepsis
•5. Patient has evidence of active liver disease or hepatic dysfunction
•6. Patient has neutropenia with absolute neutrophil count \<500 cells/mm3.
•7. Patient has history of solid organ transplantation reported at any time.
•8. Patient has any finding that, in the view of the Investigator, would compromise the patient's safety requirements.
•9. Patient has known allergies to penicillin, carbapenems, and/or cephalosporins, known allergy to probenecid, or severe allergic reactions to any drug in the past.
•10. Patient has history of intolerance to β-lactam antibiotics, including but not limited to a history of clinically significant diarrhea/loose stools.
+8 more criteria

Locations (1)

Medical Facility

St Louis, Missouri, United States

Key Dates

Start Date

April 30, 2021

Primary Completion Date

March 25, 2022

Completion Date

April 4, 2022

Last Updated

June 13, 2022

Conditions

Urinary Tract InfectionsPyelonephritis AcuteIntraabdominal Infections

Interventions

Sulopenem

DRUG

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

NCT05488340

Urinary Tract Infections

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RECRUITINGNA

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

NCT07233473

Urinary Tract Infections (UTIs)

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RECRUITING

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents

Inclusion Criteria

Exclusion Criteria

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Ureteral Stent Exchange Abstention in Urinary Tract Infections

Vaginal Ecosystem and Network in the United States Study

PRObiotics for KIdney Transplantation