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| Sponsored by: |
University of North Carolina |
|---|---|
| Information provided by: | The University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00467532 |
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: | Cohort, 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 |
Blood samples
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2009 |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Mary V Kessler, RN MSN | 919-966-3659 | mary_kessler@med.unc.edu |
| Contact: Valorie Buchholz, RN BSN | 919-966-8227 | valorie_buchholz@med.unc.edu |
| United States, North Carolina | |
| North Carolina Jaycee Burn Center, UNC Hospitals | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Principal Investigator: | Amanda Peppercorn, MD | The University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | Division of Infectious Diseases, University of North Carolina at Chapel Hill ( Amanda Peppercorn MD ) |
| Study ID Numbers: | CMV Reactivation in Burns |
| Study First Received: | April 26, 2007 |
| Last Updated: | January 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00467532 |
| Health Authority: | United States: Institutional Review Board |
|
Virus Diseases Burns Wounds and Injuries Disorders of Environmental Origin Cytomegalovirus Infections |
DNA Virus Infections Cytomegalic inclusion disease Cytomegalovirus Herpesviridae Infections |
