Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO

NCT ID: NCT04724798

Last Updated: 2021-01-26

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

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2022-12-30

Brief Summary

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Tigecycline is a commonly used antibiotic in critically ill patients. The pharmacokinetics (PK) of tigecycline in intensive care unit (ICU) patients can be affected by severe pathophysiological changes so that standard dosing might not be adequate. At present, a number of studies have reported that ECMO will affect the PK of anti-infective drugs and lead to treatment failure. The purpose of this study was to describe the population PK of tigecycline in patients treated with ECMO and to evaluate the relationship between individual PK parameters and patient covariates.

Detailed Description

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Conditions

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Extracorporeal Membrane Oxygenation Pharmacokinetics Tigecycline

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* critically ill hospitalized males or nonpregnant females aged ≥18 years with severe infections which the treating clinician was treating with tigecycline.

Exclusion Criteria

* People who had taken tigecycline in the past week
* People who were pregnant
* People who had coagulation dysfunction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhenhua Zen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southern medical university Nanfang hospital

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan Zhang, doctor

Role: CONTACT

+8615626182275

Zhenhua Zeng, doctor

Role: CONTACT

+8615692428912

Facility Contacts

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Yuan Zhang, doctor

Role: primary

+8615626182275

Other Identifiers

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NFEC-2020-021

Identifier Type: -

Identifier Source: org_study_id

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