Herpes ZosterNCT02832986
Herpes Zoster Prevalence in Frailty Consultations
An observational study of Herpes Zoster, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Herpes zoster and post herpetic pain are common causes of morbidity in the elderly. Herpes zoster is caused by reactivation of the virus varicella zoster of latent infection in sensory ganglia. The acute phase of herpes zoster usually occurs ≤ 30 days after rash onset. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Medical Questionary
- How many people
- 1,245 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jun 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients consulting in frailty consultation
Who may be able to join
- Patients consulting at the daily hospital of fragility and dependence prevention during inclusion period
Who cannot join
- Patients not consulting daily hospital of fragility and dependence prevention
- Patients consulting outside the inclusion period dates
- Patients vaccinated against zoster
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Herpes Zoster Prevalence in Frailty Consultations in University Hospital of Toulouse
Herpes zoster and post herpetic pain are common causes of morbidity in the elderly. Herpes zoster is caused by reactivation of the virus varicella zoster of latent infection in sensory ganglia. The acute phase of herpes zoster usually occurs ≤ 30 days after rash onset. However, the most common complication of herpes zoster is the post herpetic pain, which is usually defined as a persistent chronic pain for ≥ 3 months after rash onset. The risk of herpes zoster in life is 25-30%, but this figure rises to 50% among those aged ≥ 85 years. Similarly, the risk of experiencing post herpetic pain increases with age.
Despite treatment with antiviral drugs, post herpetic pain has been reported in 10-20% of all patients with herpes zoster, but its incidence increases significantly in elderly patients over 60 years. It can be particularly harmful when it occurs on a particular field, elderly multiple pathologies, fragile and with multiple treatment. In this context of decompensation "cascade" greatly exacerbate the impact of the initial local disease. Ophthalmologic involvement is rare but clinically worrisome and generates significant costs.
Read the detailed description
The annual incidence of herpes zoster in France is estimated at 3.4-4.4 cases per 1 000 people in the general population regardless of the history of Herpes zoster. The highest incidence concerns people aged 65 and over with an incidence estimated between 8-10 cases per 1 000 people, representing more than 100 000 cases of herpes zoster.
Due to the increasing number of older people in the French population, the number of herpes zoster should thus parallel increase in the coming years. The risk factors are well identified for certain (age, ethnicity ...) but for others less well defined (diabetes, composite criteria multiple pathologies ...) and insufficient to explain why some people exposed to the same risk factors will not make shingles during their lifetime.
Post herpetic pain is the leading complication of this disease with a higher risk in patients over 70 years causing a risk of autonomy loss. In fact, besides the disability of the pain itself, post herpetic pain often requires a combination of high-dose painkillers. The main therapeutic classes of analgesics used are antiepileptic in high doses (Gabapentin, Pregabalin), tricyclic antidepressants (amitriptyline), or opiates. The prevention with herpes zoster vaccine showed a reduction by 2 of risk and could therefore prevent addiction caused by induced recurrences of herpes zoster and treatment of post herpetic pain.
A study of importance is needed to further define the prevalence of this disease in the population of frail elderly and to identify factors associated with the occurrence of herpes zoster, post herpetic pain and ophthalmic zoster.
- Conditions
- Herpes Zoster
- Being tested
- Medical Questionary
- Keywords
- Frailty consultation
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical QuestionaryOther
The medical questionary will contain :
- Date of initial infection by Herpes zoster
- Localisation
- Severity
- Presence of postherpetic pain
- Postherpetic pain Intensity
- Postherpetic pain duration
- Antiviral treatment
- History of chronic pathologies
- Concomitant treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients in frailty consultation | Patients consulting in frailty consultation, at this occasion they will complete a medical questionary for the collection of study data Receives: Other: Medical Questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequence of zoster antecedent as assessed by percentage of subject with zoster antecedent
During the frailty consultation
Measured: Day 1
Secondary outcomes (5)
Frequence of ophthalmic zoster antecedent as assessed by percentage of subject with ophthalmic zoster antecedent
During the frailty consultation
Measured: Day 1
Frequence of postherpetic pain antecedent as assessed by percentage of subject with postherpetic pain antecedent
During the frailty consultation
Measured: Day 1
Risk factor associated with herpes zoster antecedent by usage of logistic regression model
Proportion of herpes zoster antecedents and characteristics will be defined by percentage of patient with medical data confirming antecedents of herpes zoster
Measured: Through the completion of study (12 months)
Risk factor associated with postherpetic pain by usage of logistic regression model
Measured: Through the completion of study (12 months)
Risk factor associated with ophthalmic zoster by usage of logistic regression model
Measured: Through the completion of study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno VELLAS, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832986
- Sponsor's protocol ID
- RC31-15-7581
- Status last verified
- Jul 2016
- First submitted
- 1 Jul 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herpes Zoster Prevalence in Frailty Consultations in University Hospital of Toulouse
- ClinicalTrials.gov ID
- NCT02832986
- Acronym / sponsor ID
- RC31-15-7581
- Conditions
- Herpes Zoster
- Keywords
- Frailty consultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,245 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Jul 2016 (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 zoster and post herpetic pain are common causes of morbidity in the elderly. Herpes zoster is caused by reactivation of the virus varicella zoster of latent infection in sensory ganglia. The acute phase of herpes zoster usually occurs ≤ 30 days after rash onset. However, the most common complication of herpes zoster is the post herpetic pain, which is usually defined as a persistent chronic pain for ≥ 3 months after rash onset. The risk of herpes zoster in life is 25-30%, but this figure rises to 50% among those aged ≥ 85 years. Similarly, the risk of experiencing post herpetic pain increases with age.
Despite treatment with antiviral drugs, post herpetic pain has been reported in 10-20% of all patients with herpes zoster, but its incidence increases significantly in elderly patients over 60 years. It can be particularly harmful when it occurs on a particular field, elderly multiple pathologies, fragile and with multiple treatment. In this context of decompensation "cascade" greatly exacerbate the impact of the initial local disease. Ophthalmologic involvement is rare but clinically worrisome and generates significant costs.
Detailed description
The annual incidence of herpes zoster in France is estimated at 3.4-4.4 cases per 1 000 people in the general population regardless of the history of Herpes zoster. The highest incidence concerns people aged 65 and over with an incidence estimated between 8-10 cases per 1 000 people, representing more than 100 000 cases of herpes zoster.
Due to the increasing number of older people in the French population, the number of herpes zoster should thus parallel increase in the coming years. The risk factors are well identified for certain (age, ethnicity ...) but for others less well defined (diabetes, composite criteria multiple pathologies ...) and insufficient to explain why some people exposed to the same risk factors will not make shingles during their lifetime.
Post herpetic pain is the leading complication of this disease with a higher risk in patients over 70 years causing a risk of autonomy loss. In fact, besides the disability of the pain itself, post herpetic pain often requires a combination of high-dose painkillers. The main therapeutic classes of analgesics used are antiepileptic in high doses (Gabapentin, Pregabalin), tricyclic antidepressants (amitriptyline), or opiates. The prevention with herpes zoster vaccine showed a reduction by 2 of risk and could therefore prevent addiction caused by induced recurrences of herpes zoster and treatment of post herpetic pain.
A study of importance is needed to further define the prevalence of this disease in the population of frail elderly and to identify factors associated with the occurrence of herpes zoster, post herpetic pain and ophthalmic zoster.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in frailty consultation | – | Other: Medical QuestionaryPatients consulting in frailty consultation, at this occasion they will complete a medical questionary for the collection of study data |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients consulting in frailty consultation
Key inclusion criteria (1 listed)
- Patients consulting at the daily hospital of fragility and dependence prevention during inclusion period
Key exclusion criteria (3 listed)
- Patients not consulting daily hospital of fragility and dependence prevention
- Patients consulting outside the inclusion period dates
- Patients vaccinated against zoster
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 |
|---|---|---|
| Medical QuestionaryThe medical questionary will contain : * Date of initial infection by Herpes zoster * Localisation * Severity * Presence of postherpetic pain * Postherpetic pain Intensity * Postherpetic pain duration * Antiviral treatment * History of chronic pathologies * Concomitant treatment | Other | Patients in frailty consultation |
Primary outcome
Frequence of zoster antecedent as assessed by percentage of subject with zoster antecedent
Time frame: Day 1
During the frailty consultation
5 secondary outcomes
Frequence of ophthalmic zoster antecedent as assessed by percentage of subject with ophthalmic zoster antecedent
Time frame: Day 1
Frequence of postherpetic pain antecedent as assessed by percentage of subject with postherpetic pain antecedent
Time frame: Day 1
Risk factor associated with herpes zoster antecedent by usage of logistic regression model
Time frame: Through the completion of study (12 months)
Risk factor associated with postherpetic pain by usage of logistic regression model
Time frame: Through the completion of study (12 months)
Risk factor associated with ophthalmic zoster by usage of logistic regression model
Time frame: Through the completion of study (12 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 14 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Bruno VELLAS, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster, run by University Hospital, Toulouse at 1 site in France.
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 1 inclusion and 3 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 14 Jul 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 France. 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.
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?
Frequence of zoster antecedent as assessed by percentage of subject with zoster antecedent (time frame: Day 1). 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 14 Jul 2016.