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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT00467532
Collaborator
(none)
60
Enrollment
1
Location
48
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Mar 1, 2007
    Actual Primary Completion Date :
    Mar 1, 2011
    Actual Study Completion Date :
    Mar 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. CMV IgG and viral load PCR [Weekly until viremia resolved (negative viral load by PCR)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 North Carolina Jaycee Burn Center, UNC Hospitals Chapel Hill North Carolina United States 27514

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Bruce Cairns, MD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bruce Cairns, MD, Medical Director, NC Jaycee Burn Center, University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT00467532
    Other Study ID Numbers:
    • CMV Reactivation in Burns
    First Posted:
    Apr 30, 2007
    Last Update Posted:
    Jan 17, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Burns

    Study Results

    No Results Posted as of Jan 17, 2013