A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Includin… (NCT06569056) | Clinical Trial Compass
RecruitingPhase 3
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
China578 participantsStarted 2024-09-25
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of HRS-8427 in patients with complicated urinary tract infection, including acute pyelonephritis.
Who can participate
Age range
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
. Able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol;
. Male and female, ≥18 years;
. Judged by the investigator, clinical diagnosis with cUTI or AP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics;
. Urine specimen with evidence of pyuria；
. Have urine culture specimen obtained within 48 hours prior to randomization;
. 48 hours before random, allowing a short course of antimicrobial drug treatment is less than 24 hours (random rate ≤25%)
. Women of childbearing potential must have a negative serum pregnancy test before first dose, must be non-lactating. Fertile female subjects or male subjects whose partner is a fertile female agree to use highly effective form of contraception, with no plan of birth, sperm/ovum donation from the time of signed ICF till 14 days after end of treatment.
Exclusion criteria
. History of significant hypersensitivity or allergic reaction to any β-lactam, or any β-lactamase inhibitors;
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
Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC)
Timeframe: Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)
. Known history of immune deficiency disease or receive immunocompromising treatment;
. Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable condition or uncontrolled;
. Known or suspected central nervous system disorder or other factors that may predispose to seizures or lower the seizures onset threshold;
. Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy;
. Uncomplicated lower urinary tract infection;
. Suspected or confirmed urinary tract symptoms caused by acute/chronic prostatitis, orchitis, epididymitis or sexually transmitted diseases as determined by medical history and/or physical examination;
. Patients received cancer treatment within 4 weeks before randomization or planned treatment during the study period;