Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients
1 other identifier
observational
500
1 country
1
Brief Summary
The investigator's purpose is to study the pharmacokinetics and pharmacodynamics of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients and recommend an individual dosage regimen of those antibiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJune 23, 2022
June 1, 2022
2 years
March 14, 2021
June 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
To detect the peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc after intravenous administration.
at (5-10) minutes after intravenous administration
The random plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
To detect the random plasma and cerebrospinal fluid drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin after intravenous administration.
at (0.5-10) hours after intravenous administration
The trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
To detect the trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin after intravenous administration.
at 1-2 hours before the next administration
Secondary Outcomes (2)
C-reaction protein
Through study completion, an average of 14 days
level of procalcitonin
Through study completion, an average of 14 days
Study Arms (1)
Treatment
The use of antimicrobial agents depends on the clinical practice.
Interventions
biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc extended infusion time or continuous infusion for 24 hours;Tigecycline changed standard does for treatment.
Eligibility Criteria
Elderly ICU patients (≥65years）treated with biapenem,meropenem,piperacillin and tazobactam,tigecycline and levofloxacin.etc who was hospitalized in the Second Hospital of Shandong University.
You may qualify if:
- (1) Age ≥65 years old; (2) According to the doctor's advice, use biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc for anti-infection treatment;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- The Second Hospital of Shandong Universitycollaborator
Study Sites (1)
Wei Zhao
Jinan, Shandong, China
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Wei Zhao, Ph.D
The Second Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of department of clinical pharmacy and pharmacoligy
Study Record Dates
First Submitted
March 14, 2021
First Posted
March 16, 2021
Study Start
April 1, 2021
Primary Completion
March 30, 2023
Study Completion
June 30, 2023
Last Updated
June 23, 2022
Record last verified: 2022-06