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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
| Qianfoshan Hospital | OTHER |
| Jinan Maternity and Child Care Hospital | UNKNOWN |
| Yantai Yuhuangding Hospital |
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This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model-based dosing regimen | Experimental | Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: GA<28 weeks: 30 mg/kg, Q8H; 28 weeks ≤GA<34 weeks: 50 mg/kg,Q8H. |
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| Empirical dosing regimen | Active Comparator | Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: 90 mg/kg,Q8H. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin/tazobactam | Drug | Piperacillin Sodium and Tazobactam Sodium for Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful outcome | Successful outcome is defined as:
| At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy ) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of NICU stay | Duration of hospital admission (days) | From the date of randomization until date of discharge, assessed up to 2 months |
| All cause in-hospital mortality | Death before discharge from NICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao, Ph.D | Contact | +8653188383308 | zhao4wei2@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao, Ph.D | Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengli Oilfield Hospital | Not yet recruiting | Dongying | China |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
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| OTHER |
| Hebei Petro China Center Hospital | UNKNOWN |
| Shengli Oilfield Hospital | OTHER |
| Liaocheng People's Hospital | OTHER |
| Jining Medical University | OTHER |
| W.F. Maternal and Child Health Hospital | UNKNOWN |
| Taian City Central Hospital | OTHER |
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| From the date of randomization until date of discharge, assessed up to 2 months |
| Proportion of patients switching to or adding another antibiotics. | Proportion of patients switching to or adding another antibiotics by any reason. | Through study completion, an average of 20 days. |
| Relapsed or new infection rate | Proportion of patients with clinically or microbiologically significant relapsed or new infection. | At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy ) |
| PD target attainment | 70%fT>MIC | Through study completion, an average of 20 days. |
| Adverse events | Drug-related adverse events and serious adverse events | Through study completion, an average of 20 days. |
| Jinan Maternity and Child Care Hospital | Not yet recruiting | Jinan | China |
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| Qianfoshan Hospital | Not yet recruiting | Jinan | China |
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| Shandong Provincial Hospital | Not yet recruiting | Jinan | China |
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| Jining Medical University | Not yet recruiting | Jining | China |
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| Hebei Petro China Center Hospital | Not yet recruiting | Langfang | China |
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| Liaocheng People's Hospital | Not yet recruiting | Liaocheng | China |
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| Taian City Central Hospital | Not yet recruiting | Tai’an | China |
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| W.F. Maternal and Child Health Hospital | Not yet recruiting | Weifang | China |
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| Yantai Yuhuangding Hospital | Recruiting | Yantai | China |
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| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |