Status:
RECRUITING
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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;
- 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;
- Systemic antimicrobial therapy other than the investigational drug need to be used during the study period, with the exception of topical or single oral dose of antifungal treatment
- Urinary tract surgery prior to 7 days before randomization or surgery planned during the study period;
- Indwelling catheter or urinary apparatus, the researchers determine drug treatment period cannot be removed;
- Receipt of potentially effective systemic antibacterial therapy for a continuous duration of ≥24 hours during the previous 48 hours prior to the randomization;
- History of pelvis or urinary tract trauma prior to the randomization;
- Patients had severe trauma or received major surgery prior to the randomization;
- Impairment of renal function with estimated glomerular filtration rate or Creatinine Clearance \<15 mL/min ;
- Laboratory abnormalities in baseline specimens obtained at screening;
- A QTcF interval prolongation at screening or abnormalities with clinical significance and may cause obvious safety risk to the subjects;
- Known urine culture with at least one Gram-Negative uropathogen at ≥105 colony-forming units(CFU)/mL unsusceptible to Imipenem and Cilastatin Sodium, or only identify Gram-positive uropathogen, or confirmed fungal urinary tract infection with ≥103CFU/mL;
- Likely to require the use of antibiotic drug prevention after treatment;
- Suspected of sepsis, producing life-threatening organ dysfunction;
- Estimated survival within 6 weeks or rapidly progressive or end stage disease with high mortality rate;
- Drug abuse prior to the randomization;
- Participated in a previous clinical study related to HRS-8427 and used HRS-8427 or have participated in another clinical study within 4 weeks before randomization and used a study drug containing the active ingredient;
- Judgment of the Investigator, other reasons unsuitable for study.
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
578 Patients enrolled
Trial Details
Trial ID
NCT06569056
Start Date
September 25 2024
End Date
November 1 2025
Last Update
January 22 2025
Active Locations (1)
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1
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040