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Antiviral Prophylaxis in a Burn Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02349828
Recruitment Status : Withdrawn (PI decided to stop due to divisional reorganization. No pts enrolled.)
First Posted : January 29, 2015
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Southern Illinois University

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Zovirax
Adult dose - 400 mg twice daily generic name: Acyclovir
Drug: Acyclovir
Other Name: Zovirax

No Intervention: No treatment
standard of care

Primary Outcome Measures :
  1. incidence of Herpes Simplex Virus [ Time Frame: 2 weeks ]
    Herpes Simplex Virus 1

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02349828

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United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9653
Sponsors and Collaborators
Southern Illinois University
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Principal Investigator: Michael W Neumeister, MD Southern Illinois Univeristy School of Medicine

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Responsible Party: Southern Illinois University Identifier: NCT02349828     History of Changes
Other Study ID Numbers: NEU-SIUSM-15-001
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Southern Illinois University:
herpes simplex virus
burn patients

Additional relevant MeSH terms:
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Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents