Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

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.

More Early-Onset Neonatal Sepsis trials

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment50 (estimated)
SponsorShandong University
Academic / other
Locations1 site (Jinan)
StatusRecruiting
StartedSeptember 30, 2023
Main results expectedJuly 1, 2026
Study endsDecember 31, 2026
Registry record updatedOctober 10, 2023
Trial IDNCT06076200 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

  • Shandong Provincial Hospital
    Jinan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.