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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruce Cairns, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00467532
First received: April 26, 2007
Last updated: January 16, 2013
Last verified: January 2013

April 26, 2007
January 16, 2013
March 2007
March 2011   (final data collection date for primary outcome measure)
CMV IgG and viral load PCR [ Time Frame: Weekly until viremia resolved (negative viral load by PCR) ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00467532 on ClinicalTrials.gov Archive Site
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Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients admitted to the North Carolina Jaycee Burn Center within 72 hours of burn injury with at least a 10% Total Body Surface (TBSA)burn and expected length of stay at least two weeks.

  • Burns
  • Cytomegalovirus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00467532
CMV Reactivation in Burns
No
Bruce Cairns, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Bruce Cairns, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP