Herpes Zoster Prevalence in Frailty Consultations

Herpes Zoster Clinical Trial

Official title:

Herpes Zoster Prevalence in Frailty Consultations in University Hospital of Toulouse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832986
• Other study ID #: RC31-15-7581
• Status: Completed
• Phase: N/A
• First received: July 1, 2016
• Last updated: July 11, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1245
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients consulting at the daily hospital of fragility and dependence prevention during inclusion period

Exclusion Criteria:

• Patients not consulting daily hospital of fragility and dependence prevention

• Patients consulting outside the inclusion period dates

• Patients vaccinated against zoster

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Other:
• Medical Questionary
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

Locations

Country	Name	City	State
France	University Hospital of Toulouse - geriatric pole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequence of zoster antecedent as assessed by percentage of subject with zoster antecedent	During the frailty consultation	Day 1	No
Secondary	Frequence of ophthalmic zoster antecedent as assessed by percentage of subject with ophthalmic zoster antecedent	During the frailty consultation	Day 1	No
Secondary	Frequence of postherpetic pain antecedent as assessed by percentage of subject with postherpetic pain antecedent	During the frailty consultation	Day 1	No
Secondary	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	Through the completion of study (12 months)	No
Secondary	Risk factor associated with postherpetic pain by usage of logistic regression model		Through the completion of study (12 months)	No
Secondary	Risk factor associated with ophthalmic zoster by usage of logistic regression model		Through the completion of study (12 months)	No