WithdrawnNCT04700787Updated Jun 13, 2022

Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents

A Phase 1 interventional study of Sulopenem in Urinary Tract Infections, Pyelonephritis Acute and Intraabdominal Infections, sponsored by Iterum Therapeutics, International Limited. Withdrawn at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-06-13.

Sponsored by Iterum Therapeutics, International Limited · Phase 1, Interventional, and Treatment

Why this study was withdrawn

Enrollment challenges and change in development plan necessitating a change in study design

Phase: Phase 1
Study type: Interventional
Enrollment: 0
Allocation: Not applicable
Ages: 12 Years to 18 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Urinary Tract Infections
Pyelonephritis Acute
Intraabdominal Infections

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In context

Urinary Tract Infections

779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.

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Lead sponsor

Iterum Therapeutics, International Limited is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

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Who can participate

Ages eligible: 12 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
Patient is male or female adolescent who are ≥12 and \<18 years of age.
Patient has a diagnosis of uUTI, cUTI, AP, or cIAI as documented by the treating physician
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.
Patient must have sufficient venous access to permit administration of study drug, collection of PK samples, and monitoring of laboratory safety variables.
Female patients who are post-menarche must not be pregnant or breast feeding and must have a documented negative serum pregnancy test at Screening.
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.
Patient must be willing to follow all study procedures.

Exclusion criteria

Exclusion Criteria:

Patient has creatinine clearance \<90 mL/min using the Cockcroft-Gault formula.
Patient is unable to tolerate oral medications.
Patient has presence of Endocarditis, Meningitis, Necrotizing fasciitis, or Gas gangrene
Patient has signs of severe sepsis
Patient has evidence of active liver disease or hepatic dysfunction
Patient has neutropenia with 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 cephalosporins, known allergy to probenecid, or severe allergic reactions to any drug in the past.
Patient has history of intolerance to β-lactam antibiotics, including but not limited to a history of clinically significant diarrhea/loose stools.
Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
Patient has involvement in the planning and/or conduct of this study
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 (eg, halothane).
Patient weighs \<35 kg.
Patient is pregnant or lactating.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Experimental
Sulopenem
Sulopenem intravenous 1000 mg (single dose) on Day 1 followed by oral sulopenem etzadroxil/probenecid 500 mg/500 mg (single dose) on Day 2.
Drug: Sulopenem

Interventions

DrugSulopenem
sulopenem intravenous 1000 mg on Day 1 and then sulopenem etzadroxil/probenecid oral 500 mg/500 mg on Day 2

What researchers measure

Primary outcomes

Maximum plasma concentration
Maximum plasma concentration (Cmax) of sulopenem at multiple timepoints after dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose

Secondary outcomes

Time to maximum plasma concentration
Time to maximum plasma concentration (Tmax) of sulopenem at multiple timepoints after dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Time above minimum inhibitory concentration
Time above minimum inhibitory concentration (MIC) at multiple timepoints after dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable plasma concentration at multiple timepoints after dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity at multiple timepoints after dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Percentage of area under the concentration-time curve extrapolated
Percentage of area under the concentration-time curve (AUC) extrapolated at multiple timepoints after dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Terminal elimination half-life
Terminal elimination half-life at multiple timepoints after dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Total body clearance for intravenous administration
Total body clearance for intravenous administration at multiple timepoints after intravenous dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Apparent total body clearance for oral administration
Apparent total body clearance for oral administration at multiple timepoints after oral dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Volume of distribution for intravenous administration
Volume of distribution for intravenous administration at multiple timepoints after intravenous dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Apparent volume of distribution for oral administration
Apparent volume of distribution for oral administration at multiple timepoints after oral dose
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose

Study locations

1 site

Medical Facility
St Louis, Missouri 63110, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04700787
Lead sponsor: Iterum Therapeutics, International Limited
Responsible party: Sponsor
First posted: Jan 8, 2021
Start date: Apr 30, 2021
Primary completion: Mar 25, 2022
Completion: Apr 4, 2022
Last update: Jun 13, 2022

Study contacts

Steven I Aronin, MD

study director · Employee

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Sulopenem

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