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This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI). Treatment duration for each cohort was 7 to 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meropenem and Pralurbactam | Experimental | Meropenem and Pralurbactam (120min infusion) |
|
| Ceftazidime-avibactam | Active Comparator | Ceftazidime-avibactam (120min infusion) 、 Metronidazole(60min infusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem and Pralurbactam | Drug | 3g,q8h,120min infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit | Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit | Up to approximately 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunsong Yu, Professor | Contact | +86-0571-85893267 | yvys119@zju.edu.cn | |
| Yuanyu Wang, Professor | Contact | +86-0571-85893889 | Lywyy1979@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yunfei Ju, MM | Qilu Pharmaceutical Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
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| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| D012965 | Sodium Chloride |
| C000595613 | avibactam, ceftazidime drug combination |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Saline |
| Drug |
100mL,q8h,60min infusion |
|
| Ceftazidime-avibactam | Drug | 2.5g,q8h,120min infusion |
|
| Metronidazole | Drug | 0.915g,q8h,60min infusion |
|
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |