Herpes SimplexPhase 2/3NCT02349828
Antiviral Prophylaxis in a Burn Population
A Phase 2/3 study testing Acyclovir in people with Herpes Simplex, run by Southern Illinois University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 24 months and older
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- Acyclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Apr 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9653
About this study
Official title: A Prospective, Randomized Trial of Antiviral Prophylaxis in a Population of Burn Patients
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.
Read the 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.
- Conditions
- Herpes Simplex
- Being tested
- Acyclovir
- Keywords
- antiviral, herpes simplex virus, herpes, burn patients, HSV, acyclovir
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
Also called Zovirax
| Study group | Role | What they receive |
|---|---|---|
| Zovirax | Active comparator | Adult dose - 400 mg twice daily generic name: Acyclovir Receives: Drug: Acyclovir |
| No treatment | No intervention | standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Herpes Simplex Virus
Herpes Simplex Virus 1
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: PI decided to stop due to divisional reorganization. No pts enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael W Neumeister, MD, Principal investigator, Southern Illinois Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349828
- Sponsor's protocol ID
- NEU-SIUSM-15-001
- Status last verified
- Apr 2016
- First submitted
- 23 Jan 2015
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial of Antiviral Prophylaxis in a Population of Burn Patients
- ClinicalTrials.gov ID
- NCT02349828
- Acronym / sponsor ID
- NEU-SIUSM-15-001
- Conditions
- Herpes Simplex
- Keywords
- antiviral, herpes simplex virus, herpes, burn patients, HSV, acyclovir
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided to stop due to divisional reorganization. No pts enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zovirax | Active comparator | Drug: AcyclovirAdult dose - 400 mg twice daily generic name: Acyclovir |
| No treatment | No intervention | –standard of care |
Who may qualify
- Ages
- 24 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcyclovirAlso: Zovirax | Drug | Zovirax |
Primary outcome
incidence of Herpes Simplex Virus
Time frame: 2 weeks
Herpes Simplex Virus 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W Neumeister, MD principal investigator
Southern Illinois Univeristy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acyclovir in people with Herpes Simplex, run by Southern Illinois University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of Herpes Simplex Virus (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.