Herpes Simplex Clinical Trial
Official title:
A Prospective, Randomized Trial of Antiviral Prophylaxis in a Population of Burn Patients
Verified date | April 2016 |
Source | Southern Illinois University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 24 Months and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
Southern Illinois University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of Herpes Simplex Virus | Herpes Simplex Virus 1 | 2 weeks | No |
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