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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00467532

Enrollment

Registered

2007-04-30

Start date

2007-03-31

Completion date

2011-03-31

Last updated

2013-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Cytomegalovirus

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
CMV IgG and viral load PCR	Weekly until viremia resolved (negative viral load by PCR)

Countries

United States

Outcome results