The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS -8427 in patients with complicated urinary tract infection, including acute pyelonephritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
The dose and frequency of administration were adjusted according to the eGFR.
The dose and frequency of administration were adjusted according to the eGFR .
Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC)
Time frame: Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)
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)
Time frame: EA : Day 4、EOT: Day 7 to Day 14、LFU:Day 21 to Day 28
Percentage of Participants With Microbiological Eradication at EA(Day 4) 、EOT(End of treatment)、TOC(7 days after end of treatment) and LFU(14 days after end of treatment)
Time frame: EA(Day 4) 、EOT(End of treatment)、TOC(7 days after end of treatment) and LFU(14 days after end of treatment)
Percentage of Participants With Microbiological Eradication at EA (Day 4)、EOT(End of treatment)、TOC(7 days after end of treatment) and LFU(14 days after end of treatment) Per Uropathogen
Time frame: EA (Day 4)、EOT(End of treatment)、TOC(7 days after end of treatment) and LFU(14 days after end of treatment) Per Uropathogen
Percentage of Participants With Clinical Response at EA(Day 4) 、EOT(End of treatment)、TOC(7 days after end of treatment) and LFU(14 days after end of treatment)
Time frame: EA(Day 4) 、EOT(End of treatment)、TOC(7 days after end of treatment) and LFU(14 days after end of treatment)
Percentage of Participants With Clinical Response at EA(Day 4) 、EOT(End of treatment)、TOC(7 days after end of treatment) and LFU (14 days after end of treatment)Per Uropathogen
Time frame: EA(Day 4) 、EOT(End of treatment)、TOC(7 days after end of treatment) and LFU (14 days after end of treatment)Per Uropathogen
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