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

Completed

• Conditions: Burns; Cytomegalovirus

• Registration Number: NCT00467532
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-26
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-04-30
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMV IgG and viral load PCR	Weekly until viremia resolved (negative viral load by PCR)

Trial Locations

Locations (1)

North Carolina Jaycee Burn Center, UNC Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States