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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-8427; Imipenem and Cilastatin Sodium placebo | Experimental |
| |
| Imipenem and Cilastatin Sodium; HRS-8427 placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8427 | Drug | Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC) | Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | EA : Day 4、EOT: Day 7 to Day 14、LFU:Day 21 to Day 28 | |
| Percentage of Participants With Microbiological Eradication at EA 、EOT、TOC and LFU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaopeng Wang | Contact | +0518-81220121 | xiaopeng.wang@hengrui.com | |
| Jing Xu | Contact | +021-23511999 | jing.xu.jx23@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41773934 | Derived | Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3. | |
| 41528248 | Derived | Wu Y, Han Q, Yang H, Xue J, Wang L, Mao X, Yin T, Jiang H, Xu S, Huang Y, Wang T, He Y, Luo Y, Chen W, Zhang J. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0109525. doi: 10.1128/aac.01095-25. Epub 2026 Jan 13. |
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| Imipenem and Cilastatin Sodium | Drug | Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses |
|
| HRS-8427 placebo | Drug | Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses |
|
| Imipenem and Cilastatin Sodium placebo | Drug | Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses |
|
| EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU:Day 21 to Day 28 |
| Percentage of Participants With Microbiological Eradication at EA 、EOT、TOC and LFU Per Uropathogen | EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU:Day 21 to Day 28 |
| Percentage of Participants With Clinical Response at EA 、EOT、TOC and LFU | EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU:Day 21 to Day 28 |
| Percentage of Participants With Clinical Response at EA 、EOT、TOC and LFU Per Uropathogen | EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU:Day 21 to Day 28 |
| Number of Participants With Adverse Events | Day 21 to Day 28 |
| 41196282 | Derived | Cao Y, Huang Y, Xie J, Wu Q, Yang S, Yang X, Huang J, Liu J, Meng J, Yang G. Intrapulmonary penetration and pharmacokinetics of siderophore cephalosporin HRS-8427 injection in Chinese healthy subjects. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0070225. doi: 10.1128/aac.00702-25. Epub 2025 Nov 6. |
| ID | Term |
|---|---|
| D000077728 | Cilastatin, Imipenem Drug Combination |
| D015378 | Imipenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D015377 | Cilastatin |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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