Identification and Validation of Biomarkers for Infections in Burns

Stopped early

Conditions studied: Burns Involving 20% or More of Body Surface

In brief

In this prospective, multi-center study, 200 patients from four participating Texas burn hospitals will be enrolled from admission to discharge. The clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. All serum samples from participating sites will be shipped to the lead site, University of Texas Medical Branch. The University of Texas Medical Branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.

Key facts

Study ID

NCT02457663

Run by

The University of Texas Medical Branch, Galveston

People needed

19

Starts

2015-04-01

Expected to finish

2019-07-11

Last updated by the study team

2019-09-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-80 years old
• Greater than 20% Total Body Surface Area burn
• Patient arrival to the burn center within 7 days of burn injury

You may not qualify if…

• Known history of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), human immunodeficiency virus (HIV)
• History of cancer within 5 years
• Pregnancy
• Burn injury due to chemical burns or deep electrical injury
• Inability to obtain informed consent
• Decision not to treat due to burn injury severity or futility as deemed by the clinical team at the time of admission (Note: This is a clinical determination of futility beyond which survival is rare. These are typically patients whose sum of Total Body Surface Area % burn and age (Baux score) exceeds 140 or 120 with severe inhalation injury.)
• Presence of anoxic brain injury that is not expected to result in complete recovery

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• U.S. Army Institute of Surgical Research — Fort Sam Houston, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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