Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO

• Conditions: Tigecycline; Pharmacokinetics; Extracorporeal Membrane Oxygenation

• Registration Number: NCT04724798
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Status Verified: 2021-01
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Study First Posted: 2021-01-26
• Last Update Posted: 2021-01-26
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum drug concentration of tigecycline	predose, 2 min, 5 min, 15 min, 30 min, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours post-dose	Serum drug concentration at different time points in each adult ICU patient treated with ECMO

Trial Locations

Locations (1)

Southern medical university Nanfang hospital; 🇨🇳 Guangzhou, China