Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370149
Status:
TERMINATED
Last Update Posted:
2016-02-24
First Post:
2006-08-28
Brief Title:
Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
A Randomized Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs Conventional Catheters in Pediatric Cardiovascular Surgery Patients
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Blinded interim analysis resulted in early termination of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to determine if a therapeutic difference exists between central venous catheters impregnated with minocycline and rifampin and conventional catheters not impregnated with antibiotics when used in children at high risk for bloodstream infections CABSI after cardiac surgery
Detailed Description:
The standard central venous catheter CVC is now commonly used for infants children and adults The antibiotic-coated CVC is a newer CVC gaining popularity for use in adults The Food and Drug Administration FDA and the Center for Disease Control CDC support use of the antibiotic-coated CVC for adult patients But the FDA and CDC have not yet endorsed use of the antibiotic-coated CVC for infants and children due to lack of research on this CVC in infants and children
Study Oversight
Has Oversight DMC:
None
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?:
None