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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
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The purpose of this study is to describe the population pharmacokinetic characteristics of piperacillin/tazobactam after intravenous administration in pregnant women during pregnancy and delivery, and to evaluate pharmacodynamic effectiveness and safety of piperacillin/tazobactam in pregnant women whose baby are at high risk of developing early-onset sepsis after birth.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin Sodium and Tazobactam Sodium for Injection | Drug | Piperacillin/Tazobactam, specification: 4g; 0.5g. Anti-infective therapy with piperacillin/tazobactam, specific regimen based on clinical practice, without intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (L/h) of piperacillin/tazobactam | The mean population pharmacokintic parameter as well as its interindividual variability | Through study completion, an average of 20 days. |
| Volume of Distribution (L) of piperacillin/tazobactam | The mean population pharmacokintic parameter as well as its interindividual variability | Through study completion, an average of 20 days. |
| Measure | Description | Time Frame |
|---|---|---|
| PD target attainment | PD target is defined as the time of free drug concentration beyond MIC during the dose interval | Through study completion, an average of 20 days. |
| Adverse events | Drug-related adverse events and serious adverse events during the study. |
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Inclusion Criteria:
Exclusion Criteria:
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The research population of this study is pregnant individuals whose baby at high risk of developing early-onset sepsis after birth.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao, Ph.D | Contact | 86053188383308 | zhao4wei2@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao, Ph.D | Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital | Recruiting | Jinan | 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 |
|---|---|
| D010878 | Piperacillin |
| D000078142 | Tazobactam |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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Biological samples include blood samples, amniotic fluid samples, placenta samples, maternal milk samples in pregnant women and umbilical cord blood samples.
| Through study completion, an average of 20 days. |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010397 | Penicillanic Acid |
| D013450 | Sulfones |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |