Early-Onset Neonatal Sepsis Clinical Trial
Official title:
Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2026 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients over 18 years old; - Pregnant women whose baby are at high risk of developing early-onset sepsis after birth have indications to use preventive or therapeutic antibiotics, and the antibiotics used are PIP/TAZO; - Patients and their families are fully aware of the research content and sign the informed consent form. Exclusion Criteria: - Intolerance or serious adverse reactions to antibiotic use; - Patients who stopped using PIP/TAZO more than 24 hours before delivery; - Receiving other systemic trial drugs; - There are other factors that the researchers think are not suitable for inclusion |
Country | Name | City | State |
---|---|---|---|
China | Shandong Provincial Hospital | Jinan |
Lead Sponsor | Collaborator |
---|---|
Shandong University | Shandong Provincial Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Secondary | 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. | |
Secondary | Adverse events | Drug-related adverse events and serious adverse events during the study. | Through study completion, an average of 20 days. |
Status | Clinical Trial | Phase | |
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