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Trial record 23 of 457 for:    Shingles

Herpes Zoster Prevalence in Frailty Consultations

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ClinicalTrials.gov Identifier: NCT02832986
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.


Condition or disease Intervention/treatment
Herpes Zoster Other: Medical Questionary

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 Type : Observational
Actual Enrollment : 1245 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Herpes Zoster Prevalence in Frailty Consultations in University Hospital of Toulouse
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Group/Cohort Intervention/treatment
Patients in frailty consultation
Patients consulting in frailty consultation, at this occasion they will complete a medical questionary for the collection of study data
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




Primary Outcome Measures :
  1. Frequence of zoster antecedent as assessed by percentage of subject with zoster antecedent [ Time Frame: Day 1 ]
    During the frailty consultation


Secondary Outcome Measures :
  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) ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients consulting in frailty consultation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832986


Locations
France
University Hospital of Toulouse - geriatric pole
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Bruno VELLAS, MD University Hospital of Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02832986     History of Changes
Other Study ID Numbers: RC31-15-7581
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Toulouse:
Frailty consultation

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases