Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients

NCT ID: NCT04799626

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Elderly Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

The use of antimicrobial agents depends on the clinical practice.

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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Shandong University

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Head of department of clinical pharmacy and pharmacoligy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Zhao, Ph.D

Role: STUDY_CHAIR

The Second Hospital of Shandong University

Locations

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Wei Zhao

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhao, Ph.D

Role: CONTACT

053188383308

Facility Contacts

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Wei Zhao, Ph.D

Role: primary

86053188383308

Other Identifiers

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2021-Antibiotics-009

Identifier Type: -

Identifier Source: org_study_id

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