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The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-8427 | Experimental |
| |
| Meropenem | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8427 | Drug | HRS-8427 for injection. |
| |
| Meropenem |
| Measure | Description | Time Frame |
|---|---|---|
| The all-cause mortality rate at Day 14. | From the first dose of the study drug to Day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| The all-cause mortality rate at Day 28. | From the first dose of the study drug to Day 28. | |
| The total ventilation time. | Day 14 to Day 21. | |
| The total ventilation time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaopeng Wang | Contact | +86-0518-81220121 | xiaopeng.wang@hengrui.com | |
| Yaru Wei | Contact | +86-010-67166319 | yaru.wei.yw37@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | 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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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Drug |
Meropenem for injection. |
|
| Day 21 to Day 28. |
| The percentage of participants with microbiologic eradication at the early assessment (EA) period. | Day 4 after the start of the treatment. |
| The percentage of participants with microbiologic eradication at the end of treatment (EOT) period. | Day 7 to 14. |
| The percentage of participants with microbiologic eradication at the test of cure (TOC) period. | Day 14 to 21. |
| The percentage of participants with microbiologic eradication at the follow-up (FU) period. | Day 21 to 28. |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |