Antiviral Prophylaxis in a Burn Population

April 19, 2016 updated by: Southern Illinois University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62794-9653
        • Southern Illinois University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of Herpes Simplex Virus
Time Frame: 2 weeks
Herpes Simplex Virus 1
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Illinois University

Investigators

  • Principal Investigator: Michael W Neumeister, MD, Southern Illinois Univeristy School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU-SIUSM-15-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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