Understanding how piperacillin/tazobactam works in pregnant women and their newborns
Official title: Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS
Run by Shandong University · NCT06076200 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan) |
| Status | Recruiting |
| Started | September 30, 2023 |
| Main results expected | July 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 10, 2023 |
| Trial ID | NCT06076200 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this study focuses on a specific population, similar pharmacokinetic studies have shown promise in optimizing antibiotic use in high-risk groups.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing if using a blood marker called presepsin can help reduce unnecessary antibiotic use in preterm infants at risk for infection.
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Amniotic fluid and the extremely preterm baby's gut
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POP-Score: A simple, non-invasive test to see if newborns might have early infection
This study tests whether the POP-Score, a non-invasive measure using NIRS and routine vitals, can predict elevated CRP in term and near-term neonates within 48 hours of birth.
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MDW as a new marker for late-onset sepsis in preterm newborns
Researchers are testing whether monocyte distribution width (MDW) can help detect late-onset neonatal sepsis in preterm babies.
-
Comparing Dopamine and Norepinephrine for Low Blood Pressure in Very Preterm Infants with Sepsis
This study is testing whether Dopamine or Norepinephrine works better to help very preterm infants with low blood pressure caused by sepsis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.