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

NCT ID: NCT00467532

Last Updated: 2013-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Burns Cytomegalovirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Bruce Cairns, MD

Medical Director, NC Jaycee Burn Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce Cairns, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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North Carolina Jaycee Burn Center, UNC Hospitals

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CMV Reactivation in Burns

Identifier Type: -

Identifier Source: org_study_id

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