Human Herpes VirusNCT02452229
Review of Human Herpes Viruses in Burns
An observational study of Human Herpes Virus and Herpes Simplex Virus, run by The University of Texas Medical Branch, Galveston.
Trial summary
Herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to play a pivotal role in morbidity and mortality in burns. Thus far, there is no existing systematic review (Level of Evidence III or higher) describing the unique role as well as concurrent infections of these viruses in burns. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Human Herpes Virus, Herpes Simplex Virus, Varicella-zoster Virus
- What is being tested?
- Review of the Literature for Human Herpes Virus infections
- How many people
- 10,267 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Every year, about 500,000 citizens of the United States of America were burned; 50,000 of them were admitted to Burn Center. Bacterial and viral infections including cellulitis, pneumonia, wound infections and septicemia are among the top ten complications of burn injuries. Severe burn injury causes an increased inflammatory response and an overall immunosuppression. As a result severely burned patients are more prone to infections and septicemia. Early treatment of sepsis and prevention of infections are key to reducing morbidity and improving the long-term outcome of burn victims.
Who may be able to join
- Patients who presented with at least 1% TBSA burned
- Patients who presented with a viral infections during their hospitalization
Who cannot join
- Patients who had no burns
- Patients who had no viral infections during their hospitalization
About this study
Official title: Human Herpes Viruses in Burn Victims: A Systematic Review
Herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to play a pivotal role in morbidity and mortality in burns. Thus far, there is no existing systematic review (Level of Evidence III or higher) describing the unique role as well as concurrent infections of these viruses in burns. The aim of this review is to point out the clinical differences between these human herpes virus subtypes, to outline established therapy approaches, and to provide evidence for virus related morbidity and mortality in burns.
Read the detailed description
This systematic review was created according the PRIMSA (preferred reporting items for systematic reviews and meta-analyses) guidelines and checklist.
We performed an review of the medical literature to identify all studies that contain HSV, CMV and VZV infections in burns.Therefore, systematic review of the Medline database by using PubMed and Ovid interface was conducted. Also the Web of Science interface was used for systematic literature search.
On the PubMed interface, we used the following search terms: ("HSV"[All Fields] OR "herpes"[All Fields] OR "CMV"[All Fields] OR "cytomegalovirus"[All Fields] OR "VZV"[All Fields] OR "varicella-zoster"[All Fields]) AND ("burns"[MeSH Terms] OR "burns"[All Fields] OR "burn"[All Fields] OR "thermal trauma"[All Fields]). For Ovid we used: exp Burns/ AND (exp Herpes Zoster/ or exp Encephalitis, Herpes Simplex/ or exp Herpes Simplex/ or exp Herpes Simples Virus Vaccines/), exp Burns/ AND (exp Cytomegalovirus/ or exp Cytomegalovirus Infections/), exp Burns/ AND (exp Chickenpox/ or Herpesvirus 3. Human/ or exp Herpes Zoster/). And for Web of Science we used: (TS=(HSV OR herpes OR CMV OR cytomegalovirus OR VZV OR varicella-zoster) AND TS=(burn OR burns OR thermal trauma)) AND LANGUAGE: (English) AND DOCUMENT TYPES: (Article); Timespan: All years; Indexes: SCI-EXPANDED, SSCI, A\&HCI, CPCI-S.
- Conditions
- Human Herpes Virus, Herpes Simplex Virus, Varicella-zoster Virus, Chickenpox, Cytomegalovirus, Burns
- Being tested
- Review of the Literature for Human Herpes Virus infections
- Medical subject headings
- Herpes Simplex, Chickenpox, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of the Literature for Human Herpes Virus infectionsOther
Review of the Medline database (PubMed and Ovid interface) for human herpes virus infections in burns as well as Web of Science interface.
PRIMSA (preferred reporting items for systematic reviews and meta-analyses) guidelines and checklist were used.
| Study group | Role | What they receive |
|---|---|---|
| Burn patients | The included patient are burn victims who sustained a burn of at least 1 % total body surface are (TBSA); with no restriction on age. Receives: Other: Review of the Literature for Human Herpes Virus infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Human Herpes Virus (HHV) Infections
HHV include the herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr viruses (EBV) and human herpes virus 6 to 8
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 months.
Secondary outcomes (1)
Treatment of Human Herpes Virus (HHV) Infections
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Herpes VirusStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 10,267 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, FACS, Study chair, Department of Surgery, University of Texas Medical Branch and Shriners Hospitals for Children, Galveston, Texas, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452229
- Sponsor's protocol ID
- SHC-G-SR-HHV
- Status last verified
- May 2015
- First submitted
- 14 May 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg. 2010;8(5):336-41. doi: 10.1016/j.ijsu.2010.02.007. Epub 2010 Feb 18. No abstract available.
PubMed 20171303
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Herpes Viruses in Burn Victims: A Systematic Review
- ClinicalTrials.gov ID
- NCT02452229
- Acronym / sponsor ID
- SHC-G-SR-HHV
- Conditions
- Human Herpes Virus, Herpes Simplex Virus, Varicella-zoster Virus, Chickenpox, Cytomegalovirus, Burns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,267 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- First posted
- 22 May 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.
Herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to play a pivotal role in morbidity and mortality in burns. Thus far, there is no existing systematic review (Level of Evidence III or higher) describing the unique role as well as concurrent infections of these viruses in burns. The aim of this review is to point out the clinical differences between these human herpes virus subtypes, to outline established therapy approaches, and to provide evidence for virus related morbidity and mortality in burns.
Detailed description
This systematic review was created according the PRIMSA (preferred reporting items for systematic reviews and meta-analyses) guidelines and checklist.
We performed an review of the medical literature to identify all studies that contain HSV, CMV and VZV infections in burns.Therefore, systematic review of the Medline database by using PubMed and Ovid interface was conducted. Also the Web of Science interface was used for systematic literature search.
On the PubMed interface, we used the following search terms: ("HSV"[All Fields] OR "herpes"[All Fields] OR "CMV"[All Fields] OR "cytomegalovirus"[All Fields] OR "VZV"[All Fields] OR "varicella-zoster"[All Fields]) AND ("burns"[MeSH Terms] OR "burns"[All Fields] OR "burn"[All Fields] OR "thermal trauma"[All Fields]). For Ovid we used: exp Burns/ AND (exp Herpes Zoster/ or exp Encephalitis, Herpes Simplex/ or exp Herpes Simplex/ or exp Herpes Simples Virus Vaccines/), exp Burns/ AND (exp Cytomegalovirus/ or exp Cytomegalovirus Infections/), exp Burns/ AND (exp Chickenpox/ or Herpesvirus 3. Human/ or exp Herpes Zoster/). And for Web of Science we used: (TS=(HSV OR herpes OR CMV OR cytomegalovirus OR VZV OR varicella-zoster) AND TS=(burn OR burns OR thermal trauma)) AND LANGUAGE: (English) AND DOCUMENT TYPES: (Article); Timespan: All years; Indexes: SCI-EXPANDED, SSCI, A\&HCI, CPCI-S.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn patients | – | Other: Review of the Literature for Human Herpes Virus infectionsThe included patient are burn victims who sustained a burn of at least 1 % total body surface are (TBSA); with no restriction on age. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Every year, about 500,000 citizens of the United States of America were burned; 50,000 of them were admitted to Burn Center. Bacterial and viral infections including cellulitis, pneumonia, wound infections and septicemia are among the top ten complications of burn injuries. Severe burn injury causes an increased inflammatory response and an overall immunosuppression. As a result severely burned patients are more prone to infections and septicemia. Early treatment of sepsis and prevention of infections are key to reducing morbidity and improving the long-term outcome of burn victims.
Key inclusion criteria (2 listed)
- Patients who presented with at least 1% TBSA burned
- Patients who presented with a viral infections during their hospitalization
Key exclusion criteria (2 listed)
- Patients who had no burns
- Patients who had no viral infections during their hospitalization
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 |
|---|---|---|
| Review of the Literature for Human Herpes Virus infectionsReview of the Medline database (PubMed and Ovid interface) for human herpes virus infections in burns as well as Web of Science interface. PRIMSA (preferred reporting items for systematic reviews and meta-analyses) guidelines and checklist were used. | Other | Burn patients |
Primary outcome
Prevalence of Human Herpes Virus (HHV) Infections
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 months.
HHV include the herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr viruses (EBV) and human herpes virus 6 to 8
1 secondary outcome
Treatment of Human Herpes Virus (HHV) Infections
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Background: PubMed 20171303Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg. 2010;8(5):336-41. doi: 10.1016/j.ijsu.2010.02.007. Epub 2010 Feb 18. No abstract available.
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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.
David N Herndon, MD, FACS study chair
Department of Surgery, University of Texas Medical Branch and Shriners Hospitals for Children, Galveston, Texas, USA
Questions about this trial
What is this clinical trial studying?
An observational study of Human Herpes Virus and Herpes Simplex Virus, run by The University of Texas Medical Branch, Galveston.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of Human Herpes Virus (HHV) Infections (time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02452229, which also lists 1 linked publication.
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 22 May 2015.