Antiviral Prophylaxis in a Burn Population

NCT02349828 | Withdrawn Phase 2 DMC

• 1 other identifier: NEU-SIUSM-15-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Simplex

Keywords

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

Outcome Measures

Primary Outcomes (1)

• incidence of Herpes Simplex Virus

  Herpes Simplex Virus 1

  2 weeks

Study Arms (2)

Zovirax

ACTIVE COMPARATOR

Adult dose - 400 mg twice daily generic name: Acyclovir

Drug: Acyclovir

No treatment

NO INTERVENTION

standard of care

Interventions

Acyclovir DRUG

Also known as: Zovirax

Zovirax

Eligibility Criteria

• Age: 24 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9653, United States

Location

MeSH Terms

Conditions

Herpes Simplex

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael W Neumeister, MD

  Southern Illinois Univeristy School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 29, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

US (1)