Clinical trial NCT01772160: Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy
Official title: Population Based Surveillance to Estimate the Burden of Herpes Zoster and Post-herpetic Neuralgia in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Zoster
Herpes Zoster Vaccine
Keywords: Adults
Italy
Herpes Zoster
Complications
Quality of life
Surveillance
Burden
Cost
Incidence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 395
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population, male or female aged ≥ 50 years of age presenting with a HZ episode.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
timeFrame: Day 0 to 2 years
Secondary outcomes:
measure: Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall
timeFrame: At Day 90, 180 and 270 after onset of HZ
measure: General Medical History of Cases With HZ, Overall
timeFrame: Between Day 0 and Day 270.
measure: Other General Medical History Characteristics for HZ Cases, Overall
timeFrame: Between Day 0 and Day 270.
measure: Clinical Information of Cases With HZ, Overall
timeFrame: Between Day 0 and Day 270
measure: Complications Related to HZ Cases, Overall
timeFrame: Between Day 0 and Day 270
measure: Other Complications Related to HZ Cases, Overall
timeFrame: Between Day 0 and Day 270
measure: Direct Medical Costs, Direct Non-medical Costs and Indirect Costs
timeFrame: Up to Day 90
measure: Worst Pain Assessment in HZ Subjects
timeFrame: At Day 90
measure: Average Pain Assessment in HZ Subjects
timeFrame: At Day 90
measure: Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory
timeFrame: At Day 0, 15, 30, 60, 90
measure: Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits
timeFrame: At Day 0, 15, 30, 60, 90
measure: PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective
timeFrame: Between Day 90 and Day 270
measure: Worst Pain Assessment in PHN Subjects
timeFrame: At Day 90
measure: Average Pain Assessment in PHN Subjects
timeFrame: At Day 90
measure: Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory
timeFrame: At Day 0, 15, 30, 60, 90
measure: Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits
timeFrame: At Day 0, 15, 30, 60, 90
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Angera (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Arcisate (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Comerio (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Fagnano Olona (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Ghirla Valganna (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Induno Olona (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Sesto Calende (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Solbiate Olona (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Varese
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Alessandria
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Frugarolo (AL)
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Oviglio (AL)
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Sale (AL)
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Villalvernia (AL)
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Cavallino (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Copertino (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Cutrofiano (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Galatina (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Montesano S. (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Parabita (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Specchia (LE)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Arcidosso (GR)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Arezzo
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Civitella Paganico (GR)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Follonica (GR)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Grosseto
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Lucignano (AR)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Orbetello (GR)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Sassofortino (GR)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Ripa (PG)
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Alessano (LE)
country: Italy
facility: GSK Investigational Site
city: Rome
country: Italy
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Salvetti A, Ferrari V, Garofalo R, Gazzaniga P, Guerroni A, Metrucci A, Sessa A, Severi ML, Nati G, Ruggeri M, Rossi A, Cappellari L, Gopala K, Tosatto R, Simone B. Incidence of herpes zoster and postherpetic neuralgia in Italian adults aged >/=50 years: A prospective study. Prev Med Rep. 2019 Apr 24;14:100882. doi: 10.1016/j.pmedr.2019.100882. eCollection 2019 Jun.
citation: Matthews S, De Maria A, Passamonti M, Ristori G, Loiacono I, Puggina A, Curran D. The Economic Burden and Impact on Quality of Life of Herpes Zoster and Postherpetic Neuralgia in Individuals Aged 50 Years or Older in Italy. Open Forum Infect Dis. 2019 Jan 12;6(2):ofz007. doi: 10.1093/ofid/ofz007. eCollection 2019 Feb.