A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
- Conditions
- Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
- Registration Number
- NCT06569056
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 578
Inclusion Criteria:<br><br> 1. Able and willing to provide a written informed consent before the study, fully<br> understand the study and be able to complete the study according to the protocol;<br><br> 2. Male and female, =18 years;<br><br> 3. Judged by the investigator, clinical diagnosis with cUTI or AP, expectation that the<br> patients will require hospitalization and initial treatment with intravenous<br> antibiotics;<br><br> 4. Urine specimen with evidence of pyuria;<br><br> 5. Have urine culture specimen obtained within 48 hours prior to randomization;<br><br> 6. 48 hours before random, allowing a short course of antimicrobial drug treatment is<br> less than 24 hours (random rate =25%)<br><br> 7. Women of childbearing potential must have a negative serum pregnancy test before<br> first dose, must be non-lactating. Fertile female subjects or male subjects whose<br> partner is a fertile female agree to use highly effective form of contraception,<br> with no plan of birth, sperm/ovum donation from the time of signed ICF till 14 days<br> after end of treatment.<br><br>Exclusion Criteria:<br><br> 1. History of significant hypersensitivity or allergic reaction to any ß-lactam, or any<br> ß-lactamase inhibitors;<br><br> 2. Known history of immune deficiency disease or receive immunocompromising treatment;<br><br> 3. Severe cardiovascular and cerebrovascular diseases with clinical significance and<br> unstable condition or uncontrolled;<br><br> 4. Known or suspected central nervous system disorder or other factors that may<br> predispose to seizures or lower the seizures onset threshold;<br><br> 5. Presence of any known or suspected disease or condition that, in the opinion of the<br> Investigator, may confound the assessment of efficacy;<br><br> 6. Uncomplicated lower urinary tract infection;<br><br> 7. Suspected or confirmed urinary tract symptoms caused by acute/chronic prostatitis,<br> orchitis, epididymitis or sexually transmitted diseases as determined by medical<br> history and/or physical examination;<br><br> 8. Patients received cancer treatment within 4 weeks before randomization or planned<br> treatment during the study period;<br><br> 9. Systemic antimicrobial therapy other than the investigational drug need to be used<br> during the study period, with the exception of topical or single oral dose of<br> antifungal treatment<br><br> 10. Urinary tract surgery prior to 7 days before randomization or surgery planned during<br> the study period;<br><br> 11. Indwelling catheter or urinary apparatus, the researchers determine drug treatment<br> period cannot be removed;<br><br> 12. Receipt of potentially effective systemic antibacterial therapy for a continuous<br> duration of =24 hours during the previous 48 hours prior to the randomization;<br><br> 13. History of pelvis or urinary tract trauma prior to the randomization;<br><br> 14. Patients had severe trauma or received major surgery prior to the randomization;<br><br> 15. Impairment of renal function with estimated glomerular filtration rate <15 mL/min ;<br><br> 16. Laboratory abnormalities in baseline specimens obtained at screening;<br><br> 17. A QTcF interval prolongation at screening or abnormalities with clinical<br> significance and may cause obvious safety risk to the subjects;<br><br> 18. Known urine culture with at least one Gram-Negative uropathogen at =105<br> colony-forming units(CFU)/mL unsusceptible to Imipenem and Cilastatin Sodium, or<br> only identify Gram-positive uropathogen, or confirmed fungal urinary tract infection<br> with =103CFU/mL;<br><br> 19. Likely to require the use of antibiotic drug prevention after treatment;<br><br> 20. Suspected of sepsis, producing life-threatening organ dysfunction;<br><br> 21. Estimated survival within 6 weeks or rapidly progressive or end stage disease with<br> high mortality rate;<br><br> 22. Drug abuse prior to the randomization;<br><br> 23. Participated in a previous clinical study related to HRS-8427 and used HRS-8427 or<br> have participated in another clinical study within 4 weeks before randomization and<br> used a study drug containing the active ingredient;<br><br> 24. Judgment of the Investigator, other reasons unsuitable for study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC)
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Early Assessment(EA)?End of Treatment(EOT)and Late Follow-Up (LFU);Percentage of Participants With Microbiological Eradication at EA ?EOT?TOC and LFU;Percentage of Participants With Microbiological Eradication at EA ?EOT?TOC and LFU Per Uropathogen;Percentage of Participants With Clinical Response at EA ?EOT?TOC and LFU;Percentage of Participants With Clinical Response at EA ?EOT?TOC and LFU Per Uropathogen;Number of Participants With Adverse Events