Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 11:18 AM
Study NCT ID:
NCT00467532
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2007-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
A Prospective Longitudinal Study of the Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Patients Sustaining Significant Burn Injury
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of burn injury on the human immune system with a focus on cytomegalovirus (CMV) reactivation and the immunologic correlates of latent viral reactivation.
Subjects will be patients admitted to the North Carolina Jaycee Burn Center with burn injury.
Blood samples will be collected over time and will be evaluated for CMV reactivation and immune cell phenotype.
Subjects will be patients admitted to the North Carolina Jaycee Burn Center with burn injury.
Blood samples will be collected over time and will be evaluated for CMV reactivation and immune cell phenotype.
Detailed Description:
The purpose of this research study is to learn about infections and the immune system in people who suffer from burn injuries. The immune system changes after burn injury and infection is one of the most common complications. Cytomegalovirus (CMV) is a virus that most people are exposed to early in life; once you are exposed it lays inactive in your body forever. When the immune system is suppressed, this virus can reactivate. We would like to measure how this virus makes copies of itself in the blood stream in people with a burn injury and to look at cell markers of the immune system.
This study involves baseline and weekly blood draws for approximately 8 weeks. If blood tests show CMV infection, further monitoring of blood work may be needed after eight weeks.
This study involves baseline and weekly blood draws for approximately 8 weeks. If blood tests show CMV infection, further monitoring of blood work may be needed after eight weeks.
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?: