Antiviral Prophylaxis in a Burn Population

Status Withdrawn

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Herpes Simplex

Clinical Trial Details

NCT number	NCT02349828
Study type	Interventional
Source	Southern Illinois University
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	September 2015
Completion date	April 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05468619` - Neonatal Phase 1 Valacyclovir Study	Phase 1
Recruiting	`NCT01176409` - Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?	Phase 3
Completed	`NCT04664127` - Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
Completed	`NCT00448227` - Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection	Phase 2
Completed	`NCT00000139` - Herpetic Eye Disease Study (HEDS) II	Phase 3
Completed	`NCT04239521` - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Completed	`NCT02209324` - Open-label Study of ASP2151 in Herpes Simplex Patients	Phase 3
Completed	`NCT00855309` - Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia	Phase 3
Completed	`NCT01602562` - Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients	Phase 3
Completed	`NCT00973466` - Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients	N/A
Completed	`NCT00698893` - Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults	Phase 1
Active, not recruiting	`NCT05298254` - A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes	Phase 1/Phase 2
Recruiting	`NCT03178747` - Tzanck Smear With Methylene Blue Stain for Herpes	Phase 3
Completed	`NCT00164424` - Episodic Acyclovir Therapy for Genital Ulcers	Phase 2/Phase 3
Completed	`NCT00161434` - A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons	Phase 4
Terminated	`NCT04762511` - A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years	Phase 1
Completed	`NCT00699764` - Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease	Phase 3
Recruiting	`NCT04065971` - Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.	Phase 4
Active, not recruiting	`NCT00005663` - A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients	Phase 3
Recruiting	`NCT00006132` - Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System	Phase 3