Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients

Elderly Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799626
• Other study ID #: 2021-Antibiotics-009
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: 053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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 ß-lactam antibiotics, Carbapenems, Ticacycline and Levofloxacin.etc drugs; (3) Patients receiving other investigational drugs; (4) Other factors that the researcher considers unsuitable for inclusion.

Related Conditions & MeSH terms

• Elderly Infection

Intervention

Drug:
• biapenem,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.

Locations

Country	Name	City	State
China	Wei Zhao	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shandong University	The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	C-reaction protein	Blood routine examination	Through study completion, an average of 14 days
Secondary	level of procalcitonin		Through study completion, an average of 14 days