Antiviral Prophylaxis in a Burn Population

Sponsor

Southern Illinois University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02349828

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex	Drug: Acyclovir	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Zovirax Adult dose - 400 mg twice daily generic name: Acyclovir	Drug: Acyclovir Other Names: Zovirax
No Intervention: No treatment standard of care

Arm

Intervention/Treatment

Active Comparator: Zovirax

Adult dose - 400 mg twice daily generic name: Acyclovir

Drug: Acyclovir

Other Names:

Zovirax

No Intervention: No treatment

standard of care

Outcome Measures

Primary Outcome Measures

incidence of Herpes Simplex Virus [2 weeks]
Herpes Simplex Virus 1

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Months and Older

Sexes Eligible for Study:

All

Accepts 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.