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Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meropenem-FL058 (180min infusion) | Experimental |
| |
| Piperacillin-Tazobactan (30min infusion) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem- FL058 | Drug | Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC). | Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication. | 5 to 9 days post-End of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ju Yunfei, MM | Contact | +86-0531-55821309 | yunfei.ju@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Huang Haihui, Professor | Huashan Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
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Double-Blind,Double-Dummy
| Piperacillin -tazobactam | Drug | Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h |
|
| Saline | Drug | 180min |
|
| Saline | Drug | 30min |
|
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |