Antiviral Prophylaxis in a Burn Population

Herpes Simplex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02349828
• Other study ID #: NEU-SIUSM-15-001
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: January 23, 2015
• Last updated: April 19, 2016
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Drug:
• Acyclovir

Locations

Country	Name	City	State
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Southern Illinois University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of Herpes Simplex Virus	Herpes Simplex Virus 1	2 weeks	No