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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
  Purpose

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
Burns
Cytomegalovirus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • CMV IgG and viral load PCR [ Time Frame: Weekly until viremia resolved (negative viral load by PCR) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467532

Locations
United States, North Carolina
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
  More Information

No publications provided

Responsible Party: Bruce Cairns, MD, Medical Director, NC Jaycee Burn Center, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00467532     History of Changes
Other Study ID Numbers: CMV Reactivation in Burns
Study First Received: April 26, 2007
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014