Trials Sponsors Conditions Drugs Pricing

Conditions

Early-Onset Neonatal Sepsis

Outcome Measures

Primary Outcomes (2)

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.
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 Outcomes (2)

PD target attainment
Through study completion, an average of 20 days.
Adverse events
Through study completion, an average of 20 days.

Interventions

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Piperacillin Sodium and Tazobactam Sodium for Injection
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The research population of this study is pregnant individuals whose baby at high risk of developing early-onset sepsis after birth.

You may qualify if:

Patients over 18 years old;

Sponsors & Collaborators

Shandong University
Otherlead
Shandong Provincial Hospital
Governmentcollaborator

Study Sites (1)

Shandong Provincial Hospital

Jinan, China

RECRUITING

Yonghui YuCONTACT

Biospecimen

Biological samples include blood samples, amniotic fluid samples, placenta samples, maternal milk samples in pregnant women and umbilical cord blood samples.

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

PiperacillinTazobactamInjections

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Study Officials

Wei Zhao, Ph.D
Shandong University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

86053188383308 zhao4wei2@hotmail.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

First Submitted

September 23, 2023

First Posted

October 10, 2023

Study Start

September 30, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations