Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Herpes Zoster

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT02487472

201926

Details and patient eligibility

About

The purpose of this study is to assess the burden of Herpes zoster (HZ) and post-herpetic neuralgia (PHN) among people ≥ 50 years old in France, in terms of healthcare resources used, medical direct and indirect costs, as well as pain severity and impact on quality of life.

Full description

• An observational, prospective cohort study of patients ≥ 50 years old with a Herpes Zoster (HZ) diagnosis, carried out by a national random sample of community first line practitioners concerned by HZ diagnosis: general practitioners, dermatologists and ophthalmologists.
• All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses and without history of previous HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved.
• All Patients of the HZ cohort presenting a Post-herpetic neuralgia (PHN) 3 months after onset of the HZ rash onset will be included secondarily in the PHN cohort
• Patients of the HZ cohort will be followed-up for 3 months (i.e. 1 and 3 months after HZ rash onset) and patients of the PHN cohort will be followed-up for additional 6 months (i.e., 6 and 9 months after HZ rash onset) using phone interviews with a nurse.
• 250 cases of HZ and 40 cases of PHN are expected, with the hypothesis of 16% of PHN 3 months after HZ rash onset.

Enrollment: 106 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For HZ cohort

  • Patient with a first visit for a diagnosis of HZ and who attend the clinic within two week of the HZ start of symptoms,
  • Without history of previous HZ,
  • ≥ 50 years old,
  • Who agree to participate and signed informed consent,
  • Able to understand the study, to complete self-administered questionnaires and to answer phone interviews.

• For PHN cohort

  • All Patients of the HZ cohort presenting PHN 3 months after onset of the HZ rash onset will be included in the PHN cohort. PHN will be defined as the presence of HZ-associated severe pains: ≥ 3 of the ZBPI item "worst pain".

Exclusion criteria

• None

Trial design

106 participants in 1 patient group

HZ cohort

Description:

All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses and no earlier case of HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved.

Treatment:

Other: Data collection