Antiviral Prophylaxis in a Burn Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis

NCT02265913

Herpes Labialis

COMPLETED PHASE3

Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL

NCT06134492

Pneumonia, Viral Ventilator Associated Pneumonia Community-acquired Pneumonia +2 more

RECRUITING PHASE3

Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions

NCT06558838

Herpes Simplex Oral

COMPLETED PHASE2

Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns

NCT06380647

Herpes Virus Infection

COMPLETED NA

Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2

NCT04222985

Genital Herpes

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Herpes Simplex

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Zovirax

Adult dose - 400 mg twice daily generic name: Acyclovir

Group Type ACTIVE_COMPARATOR

Acyclovir

Intervention Type DRUG

No treatment

standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acyclovir

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zovirax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No