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Antiviral Prophylaxis in a Burn Population

Information source: Southern Illinois University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Encephalitis, Herpes Simplex

Intervention: Acyclovir (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Southern Illinois University

Official(s) and/or principal investigator(s):
Michael W Neumeister, MD, Principal Investigator, Affiliation: Southern Illinois Univeristy School of Medicine

Overall contact:
Michael W Neumeister, MD, Phone: 217-545-6314, Email: mneumeister@siumed.edu

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.

Clinical Details

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

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

Primary outcome: incidence of Herpes Simplex Virus

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.

Eligibility

Minimum age: 24 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients presenting to Memorial Medical Center's Regional Burn Unit, both transfers

and direct admissions, including patients who are:

- initially evaluated in the Emergency Department

- requiring intubation greater than 24 hours

- with inhalational injury

- with superficial partial thickness burns and deep partial thickness burns

(second degree)

- with full thickness burns (third degree)

- with burns that extend down to muscle and bone (fourth degree)

- 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 cognitively competent to give consent.

Exclusion Criteria:

- Patients who are unable to consent to participate or whom do not wish to consent to

all facets of the study (ie, photography)

- 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.

Locations and Contacts

Michael W Neumeister, MD, Phone: 217-545-6314, Email: mneumeister@siumed.edu

Southern Illinois University School of Medicine, Springfield, Illinois 62794-9653, United States; Recruiting
Michael W Neumeister, MD, Phone: 217-545-6314, Email: mneumeister@siumed.edu
Shaun Mendenhall, MD, Phone: 217-545-6314, Email: smendenhall@siumed.edu
Michael W Neumeister, MD, Principal Investigator
Nada N Berry, MD, Sub-Investigator
Nicole Z Sommer, MD, Sub-Investigator
Shaun D Mendenhall, MD, Sub-Investigator
Additional Information

Starting date: January 2015
Last updated: August 5, 2015

Page last updated: August 23, 2015

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