Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients

Population Pharmacokinetics and Dosage Individualization of Biapenem,Meropenem,Piperacillin and Tazobactam,Tigecycline,Levofloxacin .Etc in Elderly Patients Who Was Hospitalized in Intensive Care Unit

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04799626

Enrollment

500

Registered

2021-03-16

Start date

2021-04-01

Completion date

2023-06-30

Last updated

2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Infection

Keywords

biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc, elderly ICU patients, dosage regimen, pharmacokinetics and pharmacodynamics

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.

Interventions

DRUGbiapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc

biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc extended infusion time or continuous infusion for 24 hours;Tigecycline changed standard does for treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

China

Contacts

Primary ContactWei Zhao, Ph.D

zhao4wei2@hotmail.com053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026