Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Herpes Zoster Vaccine; Herpes Zoster

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01772160

116208

Details and patient eligibility

About

The purpose of this study is to collect data on the incidence, complications, economic burden and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.

Full description

The surveillance/recruitment period will take approximately 2 years and once the enrolment of HZ patients has ended, the study will continue for a maximum of 9 months to allow for completion of the follow-up of potential PHN cases.

The data will be captured at protocol specified time-points based on the time of enrolment of each subject.

Enrollment: 395 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A male or female ≥ 50 years of age at the time of study enrolment presenting with acute HZ.

• HZ diagnosis for this HZ episode:

  • Is his/her first outpatient diagnosis (i.e. initial consultation), OR
  • Took place at another site/centre (e.g. emergency room or Dermatologist/Specialist practice) provided the HZ diagnosis is not more than 7 days before the initial visit for the present study (i.e. secondary consultation).

• Written informed consent obtained from the patient.

• Ability to comply with study procedures.

Exclusion criteria

• Patient participating in another clinical study (participation in another observational, non-interventional trial is allowed).

Trial design

395 participants in 1 patient group

Herpes Zoster Group

Description:

Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.

Treatment:

Other: Data collection