Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients
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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 |
- 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) |
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 |
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.
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| United States, North Carolina | |
| North Carolina Jaycee Burn Center, UNC Hospitals | |
| Chapel Hill, North Carolina, United States, 27514 | |
| 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 May 23, 2013