Antiviral Prophylaxis in a Burn Population

Southern Illinois University

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Herpes Simplex

Treatments

Drug: Acyclovir

Study type

Interventional

Funder types

Other

Identifiers

NCT02349828

NEU-SIUSM-15-001

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

24+ months old

Volunteers

No Healthy Volunteers

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.