Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects.
Tengrui Yin, Biao Qu, Qian Zhang...
https://pubmed.ncbi.nlm.nih.gov/41773934Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06569056
Study Evaluating HRS-8427 Compared to Imipenem and Cilastatin Sodium for Adults With Complicated Urinary Tract Infection Including Acute Pyelonephritis in a Randomized, Double-Blind, Active-Controlled Design
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
Researchers are evaluating the effectiveness and safety of HRS-8427 in adults with complicated urinary tract infections, including acute pyelonephritis. This Phase III, multi-center, randomized, double-blind study aims to compare HRS-8427 with imipenem and cilastatin sodium, both with corresponding placebos, to treat these infections that often require hospitalization and intravenous antibiotics. Participants will receive either HRS-8427, imipenem and cilastatin sodium, or their placebos for 7 to 14 days, with dose adjustments made for those with reduced kidney function. The study involves parallel groups and active controls to assess treatment response. During the study, researchers will monitor clinical and microbiological responses, focusing on the percentage of participants who achieve both successful eradication of the infection and clinical improvement at the test of cure visit, which occurs 7 days after the end of treatment (between study days 14 to 21). Participants will provide urine samples and undergo safety assessments throughout the trial to evaluate treatment effects and monitor adverse events.
CONDITIONS
Official Title
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Who Can Participate
Age: 18Years +
All Genders
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
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1
2
3
Trial Site Locations
Total: 1 location
1
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
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Research Team
X
Xiaopeng Wang
J
Jing Xu
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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Published Research Related To This Trial
Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections.
Yuanhao Wu, Qiwen Han, Haijing Yang...
https://pubmed.ncbi.nlm.nih.gov/41528248Intrapulmonary penetration and pharmacokinetics of siderophore cephalosporin HRS-8427 injection in Chinese healthy subjects.
Yichen Cao, Yuanyuan Huang, Jinlian Xie...
https://pubmed.ncbi.nlm.nih.gov/41196282