- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467532
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- North Carolina Jaycee Burn Center, UNC Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CMV IgG and viral load PCR
Time Frame: Weekly until viremia resolved (negative viral load by PCR)
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Weekly until viremia resolved (negative viral load by PCR)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMV Reactivation in Burns
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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