Actively Recruiting
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-01-22
578
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and complete the study as required
- Male or female aged 18 years or older
- Clinically diagnosed with complicated urinary tract infection or acute pyelonephritis, expected to require hospitalization and intravenous antibiotics
- Evidence of pyuria in urine specimen
- Urine culture specimen obtained within 48 hours before randomization
- Short course of antimicrobial treatment allowed less than 24 hours within 48 hours before randomization (random rate ≤25%)
- Women of childbearing potential must have a negative serum pregnancy test before first dose and be non-lactating
- Fertile female subjects or males with fertile female partners must agree to use effective contraception from consent until 14 days after treatment end
You will not qualify if you...
- History of significant allergy to beta-lactam or beta-lactamase inhibitors
- Known immune deficiency or receiving immunocompromising treatment
- Severe unstable cardiovascular or cerebrovascular diseases
- Known or suspected central nervous system disorder increasing seizure risk
- Conditions that may confound efficacy assessment
- Uncomplicated lower urinary tract infection
- Urinary symptoms caused by prostatitis, orchitis, epididymitis, or sexually transmitted diseases
- Cancer treatment within 4 weeks before randomization or planned during study
- Use of systemic antimicrobial therapy other than study drugs during study (except topical or single oral antifungal dose)
- Urinary tract surgery within 7 days before randomization or planned surgery during study
- Indwelling catheter or urinary device that cannot be removed during treatment
- Use of effective systemic antibacterial therapy for 24 hours or more in 48 hours before randomization
- History of pelvis or urinary tract trauma before randomization
- Severe trauma or major surgery before randomization
- Severe kidney impairment with GFR or creatinine clearance less than 15 mL/min
- Significant laboratory abnormalities at screening
- Prolonged QTcF interval or clinically significant abnormalities increasing safety risk
- Urine culture with Gram-negative uropathogen resistant to imipenem and cilastatin sodium, only Gram-positive uropathogen, or fungal urinary infection
- Likely need for antibiotic prophylaxis after treatment
- Suspected sepsis with life-threatening organ dysfunction
- Expected survival less than 6 weeks or rapidly progressive terminal disease
- History of drug abuse before randomization
- Previous use of HRS-8427 or participation in related clinical study within 4 weeks
- Any other reason investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
X
Xiaopeng Wang
CONTACT
J
Jing Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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