Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients

• Conditions: Elderly Infection
• Interventions: Drug: biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc

• Registration Number: NCT04799626
• Lead Sponsor: Shandong University

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.

Detailed Description

The use of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients during clinical treatment depended mostly on experience. Besides, there was no recommended dose for elderly patients in drug instruction, Therefore, we aim to study the pharmacokinetics and pharmacodynamics in elderly ICU patients and provide a tailormade regimen.

Study Timeline

• Study First Submitted: 2021-03-14
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Study Start: 2021-04-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-23
• Primary Completion: 2023-03-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• (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;

Exclusion Criteria

• (1) Patients who are expected to die within 48 hours; (2) Patients with allergic to β-lactam antibiotics, Carbapenems, Ticacycline and Levofloxacin.etc drugs; (3) Patients receiving other investigational drugs; (4) Other factors that the researcher considers unsuitable for inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc	The use of antimicrobial agents depends on the clinical practice.

Primary Outcome Measures

Name	Time	Method
The peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc	at (5-10) minutes after intravenous administration	To detect the peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc after intravenous administration.
The random plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc	at (0.5-10) hours after intravenous administration	To detect the random plasma and cerebrospinal fluid drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin after intravenous administration.
The trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc	at 1-2 hours before the next administration	To detect the trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin after intravenous administration.

Secondary Outcome Measures

Name	Time	Method
C-reaction protein	Through study completion, an average of 14 days	Blood routine examination
level of procalcitonin	Through study completion, an average of 14 days

Trial Locations

Locations (1)

Wei Zhao; 🇨🇳 Jinan, Shandong, China