Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2020
CompletedFirst Submitted
Initial submission to the registry
January 19, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedJanuary 26, 2021
January 1, 2021
2.9 years
January 19, 2021
January 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
critically ill hospitalized males or nonpregnant females aged ≥18 years with severe infections which the treating clinician was treating with tigecycline.
You may qualify if:
- critically ill hospitalized males or nonpregnant females aged ≥18 years with severe infections which the treating clinician was treating with tigecycline.
You may not qualify if:
- People who had taken tigecycline in the past week
- People who were pregnant
- People who had coagulation dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern medical university Nanfang hospital
Guangzhou, 510515, China
Biospecimen
Blood
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 19, 2021
First Posted
January 26, 2021
Study Start
January 20, 2020
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
January 26, 2021
Record last verified: 2021-01