NCT02832986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

July 1, 2016

Last Update Submit

July 11, 2016

Conditions

Keywords

Frailty consultation

Outcome Measures

Primary Outcomes (1)

  • Frequence of zoster antecedent as assessed by percentage of subject with zoster antecedent

    During the frailty consultation

    Day 1

Secondary Outcomes (5)

  • Frequence of ophthalmic zoster antecedent as assessed by percentage of subject with ophthalmic zoster antecedent

    Day 1

  • Frequence of postherpetic pain antecedent as assessed by percentage of subject with postherpetic pain antecedent

    Day 1

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

    Through the completion of study (12 months)

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

    Through the completion of study (12 months)

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

    Through the completion of study (12 months)

Study Arms (1)

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

Interventions

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

Patients in frailty consultation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting in frailty consultation

You may not qualify if:

  • Patients not consulting daily hospital of fragility and dependence prevention
  • Patients vaccinated against zoster

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse - geriatric pole

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Bruno VELLAS, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 14, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations