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Completed

NCT Number: NCT02832986

Herpes Zoster Prevalence in Frailty Consultations

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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Toulouse - geriatric pole

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Questionary

Other

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

Primary outcomes

  1. Frequence of zoster antecedent as assessed by percentage of subject with zoster antecedent

    Time frame: Day 1

    During the frailty consultation

Secondary outcomes

  1. Frequence of ophthalmic zoster antecedent as assessed by percentage of subject with ophthalmic zoster antecedent

    Time frame: Day 1

    During the frailty consultation

  2. Frequence of postherpetic pain antecedent as assessed by percentage of subject with postherpetic pain antecedent

    Time frame: Day 1

    During the frailty consultation

  3. Risk factor associated with herpes zoster antecedent by usage of logistic regression model

    Time frame: Through the completion of study (12 months)

    Proportion of herpes zoster antecedents and characteristics will be defined by percentage of patient with medical data confirming antecedents of herpes zoster

  4. Risk factor associated with postherpetic pain by usage of logistic regression model

    Time frame: Through the completion of study (12 months)

  5. Risk factor associated with ophthalmic zoster by usage of logistic regression model

    Time frame: Through the completion of study (12 months)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Herpes Zoster Prevalence in Frailty Consultations in University Hospital of Toulouse

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 14, 2016
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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