Antiviral Prophylaxis in a Burn Population



Status:Not yet recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:September 2015
End Date:September 2020
Contact:Michael W Neumeister, MD
Email:mneumeister@siumed.edu
Phone:217-545-6314

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A Prospective, Randomized Trial of Antiviral Prophylaxis in a Population of Burn Patients

A prospective, randomized trial to calculate incidence of Herpes Simplex Virus in an
in-patient burn population and determine efficacy of prophylactic antiviral therapy to
prevent viral infection and/or reactivation. Hypothesis is that antiviral prophylaxis will
be effective in reducing HSV infection/reactivation.

A prospective, randomized trial of antiviral prophylaxis of at risk individuals has yet to
be performed. We anticipate that the disease burden in our population of burn patients will
be large, especially in patients who exhibit high risk characteristics, and hypothesize that
antiviral prophylaxis will significantly reduce the incidence of Herpes Simplex Virus in the
burn population. This study will have a profound impact on the treatment of burn patients
both at our own institution and throughout the country. Prophylactic treatment using
Acyclovir in burn patients would decrease patient morbidity, pain and suffering and would
likely positively impact scarring, wound healing, and, ultimately, patient satisfaction and
quality of life. Reducing the incidence of HSV infections will decrease the length of
hospital stays for many patients, saving both health care expenses and resources. If
prophylactic Acyclovir becomes standard of care treatment for burn patients, this treatment
plan would be a tremendous public health breakthrough for preventing HSV outbreaks and could
be extrapolated to researching similar protocols for other health conditions.

Inclusion Criteria:

- Patients presenting to Memorial Medical Center's Regional Burn Unit, both transfers
and direct admissions

- Patients aged 24 months to 110 years old

- Patients presenting with thermal, flame, flash, chemical, grease or electrical burns

- Patients with second degree or higher burn to the face or burn to any part of the
body of 20% TBSA or greater

- Patients, power of attorney or legally authorized representative cognitively
competent to give consent.

Exclusion Criteria:

- Patients who do not wish to consent to all facets of the study

- Patients younger than 24 months

- Patients older than 110 years of age

- Patients with mechanical skin injury (ie, road rash, crush injury)

- Patients who are pregnant or become pregnant during the treatment phase of the study

- Patients with a documented allergy to Acyclovir, Famcyclovir or Valacyclovir

- Patients already taking Acyclovir, Famcyclovir or Valacyclovir

- Patients who have or develop thrombotic thrombocytopenic purpura

- Patients have or develop hemolytic uremic syndrome

- Patients concurrently taking Tizanidine, Phenytoin, Valproic Acid, Fosphenytoin,
Meperidine, Micophenolic Acid, Tenofovir Disoproxil Fumarate, or Zidovudine

- Patients whom the investigator feels would be inappropriate.
We found this trial at
1
site
801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Principal Investigator: Michael W Neumeister, MD
Phone: 217-545-6314
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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mi
from
Springfield, IL
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