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 range18 Years
SexALL
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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;
✕. Known history of immune deficiency disease or receive immunocompromising treatment;
✕. Severe cardiovascular and cerebrovascular diseases with clinical significance and unstable condition or uncontrolled;
✕
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 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;