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NCT04724798 Clinical Trial

Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO

Pharmacokinetics Clinical Trial

Official title:
Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04724798
Other study ID # NFEC-2020-021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 20, 2020
Est. completion date December 30, 2022

Study information
Verified date January 2021
Source Nanfang Hospital of Southern Medical University
Contact Yuan Zhang, doctor
Phone +8615626182275
Email m15626182275@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Southern medical university Nanfang hospital Guangzhou

Sponsors (1)
Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum drug concentration of tigecycline Serum drug concentration at different time points in each adult ICU patient treated with ECMO predose, 2 min, 5 min, 15 min, 30 min, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours post-dose
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