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Antiviral Prophylaxis in a Burn Population

Primary Purpose

Herpes Simplex

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Acyclovir

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring antiviral, herpes simplex virus, herpes, burn patients, HSV, acyclovir

Eligibility Criteria

24 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Southern Illinois University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Zovirax

No treatment

Arm Description

Adult dose - 400 mg twice daily generic name: Acyclovir

standard of care

Outcomes

Primary Outcome Measures

incidence of Herpes Simplex Virus

Herpes Simplex Virus 1

Secondary Outcome Measures

Full Information

NCT ID

NCT02349828

First Posted

January 23, 2015

Last Updated

April 19, 2016

Sponsor

Southern Illinois University

1. Study Identification

Unique Protocol Identification Number

NCT02349828

Brief Title

Antiviral Prophylaxis in a Burn Population

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Withdrawn

Why Stopped

PI decided to stop due to divisional reorganization. No pts enrolled.

Study Start Date

September 2015 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Southern Illinois University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Simplex

Keywords

antiviral, herpes simplex virus, herpes, burn patients, HSV, acyclovir

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zovirax

Arm Type

Active Comparator

Arm Description

Adult dose - 400 mg twice daily generic name: Acyclovir

Arm Title

No treatment

Arm Type

No Intervention

Arm Description

standard of care

Intervention Type

Drug

Intervention Name(s)

Acyclovir

Other Intervention Name(s)

Zovirax

Primary Outcome Measure Information:

Title

incidence of Herpes Simplex Virus

Description

Herpes Simplex Virus 1

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael W Neumeister, MD

Organizational Affiliation

Southern Illinois Univeristy School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Southern Illinois University School of Medicine

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62794-9653

Country

United States

12. IPD Sharing Statement

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Antiviral Prophylaxis in a Burn Population

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