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Completed

NCT Number: NCT00467532

Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Carolina Jaycee Burn Center, UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. CMV IgG and viral load PCR

    Time frame: Weekly until viremia resolved (negative viral load by PCR)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 30, 2007
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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