Antiviral Prophylaxis in a Burn Population

• Status: Withdrawn
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern Illinois University
• Treatments: Acyclovir; Antiviral Agents

Criteria

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.