Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents (NCT04700787) | Clinical Trial Compass
WithdrawnPhase 1
Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents
Stopped: Enrollment challenges and change in development plan necessitating a change in study design
United States0Started 2021-04-30
Plain-language 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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum plasma concentration
Timeframe: 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
. 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
. 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.