NCT00467532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

4 years

First QC Date

April 26, 2007

Last Update Submit

January 16, 2013

Conditions

BurnsCytomegalovirus

Outcome Measures

Primary Outcomes (1)

  • CMV IgG and viral load PCR

    Weekly until viremia resolved (negative viral load by PCR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Burn injury,
  • Positive CMV IgG level confirmative of previous CMV infection and latency.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Jaycee Burn Center, UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Bruce Cairns, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, NC Jaycee Burn Center

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 30, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)