Early-Onset Neonatal SepsisNCT06076200
Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations
An observational study of Early-Onset Neonatal Sepsis, run by Shandong University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early-Onset Neonatal Sepsis
- What is being tested?
- Piperacillin Sodium and Tazobactam Sodium for Injection
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The research population of this study is pregnant individuals whose baby at high risk of developing early-onset sepsis after birth.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan
Yonghui Yu
About this study
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.
- Conditions
- Early-Onset Neonatal Sepsis
- Being tested
- Piperacillin Sodium and Tazobactam Sodium for Injection
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin Sodium and Tazobactam Sodium for InjectionDrug
Piperacillin/Tazobactam, specification: 4g; 0.5g. Anti-infective therapy with piperacillin/tazobactam, specific regimen based on clinical practice, without intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance (L/h) of piperacillin/tazobactam
The mean population pharmacokintic parameter as well as its interindividual variability
Measured: 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
Measured: Through study completion, an average of 20 days.
Secondary outcomes (2)
PD target attainment
PD target is defined as the time of free drug concentration beyond MIC during the dose interval
Measured: Through study completion, an average of 20 days.
Adverse events
Drug-related adverse events and serious adverse events during the study.
Measured: Through study completion, an average of 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Sep 2023 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Onset Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Ph.D, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076200
- Sponsor's protocol ID
- SDU-2023-PPK-005
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS
- ClinicalTrials.gov ID
- NCT06076200
- Acronym / sponsor ID
- SDU-2023-PPK-005
- Conditions
- Early-Onset Neonatal Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research population of this study is pregnant individuals whose baby at high risk of developing early-onset sepsis after birth.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin Sodium and Tazobactam Sodium for InjectionPiperacillin/Tazobactam, specification: 4g; 0.5g. Anti-infective therapy with piperacillin/tazobactam, specific regimen based on clinical practice, without intervention. | Drug | – |
Primary outcome
Clearance (L/h) of piperacillin/tazobactam
Time frame: Through study completion, an average of 20 days.
The mean population pharmacokintic parameter as well as its interindividual variability
Volume of Distribution (L) of piperacillin/tazobactam
Time frame: Through study completion, an average of 20 days.
The mean population pharmacokintic parameter as well as its interindividual variability
2 secondary outcomes
PD target attainment
Time frame: Through study completion, an average of 20 days.
Adverse events
Time frame: Through study completion, an average of 20 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Zhao, Ph.D principal investigator
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early-Onset Neonatal Sepsis, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance (L/h) of piperacillin/tazobactam (time frame: Through study completion, an average of 20 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.