Viewing Study NCT03720132


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Study NCT ID: NCT03720132
Status: TERMINATED
Last Update Posted: 2018-10-29
First Post: 2016-11-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
Sponsor: Universitaire Ziekenhuizen KU Leuven
Organization:

Study Overview

Official Title: Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
Status: TERMINATED
Status Verified Date: 2018-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Emerging evidence made the trial unnecessary.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared with simultaneously taken peripheral samples.
Detailed Description: In this study, extensive flushing of the port catheter prior to blood sampling to determine vancomycin trough levels, will be compared with normal flushing. To ascertain correctness of the trough levels taken via the central catheter, sampling will occur through a peripheral catheter simultaneously.

Flushing will be done with sodium chloride 0.9 % solution.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: