Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467532
• Other study ID #: CMV Reactivation in Burns
• Status: Completed
• Phase: N/A
• First received: April 26, 2007
• Last updated: January 16, 2013
• Start date: March 2007
• Est. completion date: March 2011

Study information

• Verified date: January 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Burn injury,

• Positive CMV IgG level confirmative of previous CMV infection and latency.

Exclusion Criteria:

• Immunocompromising conditions including HIV/AIDS,

• End-stage renal disease,

• End-stage liver disease,

• Pregnancy,

• Rheumatologic or collagen-vascular disease requiring chronic use of steroids,

• Chronic use of immunosuppressive agents,

• Recent chemotherapy, and

• History of solid organ or allogeneic stem cell transplant.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Burns
• Cytomegalovirus

Locations

Country	Name	City	State
United States	North Carolina Jaycee Burn Center, UNC Hospitals	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV IgG and viral load PCR		Weekly until viremia resolved (negative viral load by PCR)	No