Clinical trial NCT04799626: Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elderly Infection
Keywords: biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
elderly ICU patients
dosage regimen
pharmacokinetics and pharmacodynamics
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Shandong University
First posted: 2021-03-16
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The peak plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
timeFrame: at (5-10) minutes after intravenous administration
measure: The random plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
timeFrame: at (0.5-10) hours after intravenous administration
measure: The trough plasma drug concentration of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc
timeFrame: at 1-2 hours before the next administration
Secondary outcomes:
measure: C-reaction protein
timeFrame: Through study completion, an average of 14 days
measure: level of procalcitonin
timeFrame: Through study completion, an average of 14 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Wei Zhao
state: Shandong
Study officials:
affiliation: The Second Hospital of Shandong University
name: Wei Zhao, Ph.D
role: STUDY_CHAIR
References: