Understanding how piperacillin/tazobactam works in pregnant women and their newborns
Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS
This study looks at how the antibiotic piperacillin/tazobactam works in pregnant women and their newborns to see if it can safely help prevent serious infections in babies at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan) |
| Trial ID | NCT06076200 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the population pharmacokinetics of piperacillin/tazobactam administered intravenously to pregnant women during pregnancy and delivery. It will evaluate the pharmacodynamic effectiveness and safety of this antibiotic in mothers whose newborns are at high risk for early-onset neonatal sepsis. By analyzing how the drug behaves in both maternal and neonatal populations, the study seeks to optimize treatment protocols for this vulnerable group.
Who should consider this trial
Good fit: Ideal candidates include pregnant women over 18 whose babies are at high risk of developing early-onset sepsis and require piperacillin/tazobactam treatment.
Not a fit: Patients who have serious adverse reactions to antibiotics or who are not suitable for inclusion due to other health factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of early-onset neonatal sepsis, leading to better outcomes for at-risk newborns.
How similar studies have performed: While this study focuses on a specific population, similar pharmacokinetic studies have shown promise in optimizing antibiotic use in high-risk groups.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jinan
- Shandong Provincial Hospital — Jinan, China (Recruiting)
Study contacts
- Principal investigator: Wei Zhao, Ph.D — Shandong University
- Study coordinator: Wei Zhao, Ph.D
- Email: zhao4wei2@hotmail.com
- Phone: 86053188383308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.