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

NCT01772160 | Completed Results

• 1 other identifier: 116208
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 43

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.

Conditions

Herpes Zoster; Herpes Zoster Vaccine

Keywords

Adults; Italy; Herpes Zoster; Complications; Quality of life; Surveillance; Burden; Cost; Incidence

Outcome Measures

Primary Outcomes (1)

• Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender

  A case of HZ was defined as new unilateral pain (broadly defined to include allodynia and pruritus) accompanied by unilateral rash and no alternative diagnosis. Age ranges were 50-54, 55-59, 60-64, 65-69, 70-74, 75-79 and greater than or equal to (≥) 80 years. The incidence rate was expressed as the number of HZ cases per (/) 1000 person-years.

  Day 0 to 2 years

Secondary Outcomes (16)

• Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall

  At Day 90, 180 and 270 after onset of HZ

• General Medical History of Cases With HZ, Overall

  Between Day 0 and Day 270.

• Other General Medical History Characteristics for HZ Cases, Overall

  Between Day 0 and Day 270.

• Clinical Information of Cases With HZ, Overall

  Between Day 0 and Day 270

• Complications Related to HZ Cases, Overall

  Between Day 0 and Day 270

Study Arms (1)

Herpes Zoster Group

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

Other: Data collection

Interventions

Data collection OTHER

HZ/PHN booklet, HZ/PHN file and logbook. HZ/PHN booklet will be completed by the patient and the HZ/PHN file and logbook will be completed by the participating general practitioner.

Herpes Zoster Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult population, male or female aged ≥ 50 years of age presenting with a HZ episode.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (43)

GSK Investigational Site

Cavallino (LE), Apulia, 73020, Italy

Location

GSK Investigational Site

Copertino (LE), Apulia, 73043, Italy

Location

GSK Investigational Site

Cutrofiano (LE), Apulia, 73020, Italy

Location

GSK Investigational Site

Galatina (LE), Apulia, 73013, Italy

Location

GSK Investigational Site

Montesano S. (LE), Apulia, 73035, Italy

Location

GSK Investigational Site

Parabita (LE), Apulia, 73052, Italy

Location

GSK Investigational Site

Specchia (LE), Apulia, 73040, Italy

Location

GSK Investigational Site

Napoli, Campania, 80125, Italy

Location

GSK Investigational Site

Napoli, Campania, 80126, Italy

Location

GSK Investigational Site

Rome, Lazio, 00141, Italy

Location

GSK Investigational Site

Rome, Lazio, 00142, Italy

Location

GSK Investigational Site

Rome, Lazio, 00144, Italy

Location

GSK Investigational Site

Rome, Lazio, 00162, Italy

Location

GSK Investigational Site

Rome, Lazio, 00176, Italy

Location

GSK Investigational Site

Rome, Lazio, 00197, Italy

Location

GSK Investigational Site

Angera (VA), Lombardy, Italy

Location

GSK Investigational Site

Arcisate (VA), Lombardy, 21051, Italy

Location

GSK Investigational Site

Comerio (VA), Lombardy, 21020, Italy

Location

GSK Investigational Site

Fagnano Olona (VA), Lombardy, 21054, Italy

Location

GSK Investigational Site

Ghirla Valganna (VA), Lombardy, 21030, Italy

Location

GSK Investigational Site

Induno Olona (VA), Lombardy, 21040, Italy

Location

GSK Investigational Site

Sesto Calende (VA), Lombardy, 21018, Italy

Location

GSK Investigational Site

Solbiate Olona (VA), Lombardy, 21052, Italy

Location

GSK Investigational Site

Varese, Lombardy, 21100, Italy

Location

GSK Investigational Site

Alessandria, Piedmont, 15121, Italy

Location

GSK Investigational Site

Frugarolo (AL), Piedmont, 15065, Italy

Location

GSK Investigational Site

Oviglio (AL), Piedmont, 15026, Italy

Location

GSK Investigational Site

Sale (AL), Piedmont, 15045, Italy

Location

GSK Investigational Site

Villalvernia (AL), Piedmont, 15050, Italy

Location

GSK Investigational Site

Arcidosso (GR), Tuscany, 58031, Italy

Location

GSK Investigational Site

Arezzo, Tuscany, 52100, Italy

Location

GSK Investigational Site

Civitella Paganico (GR), Tuscany, 58045, Italy

Location

GSK Investigational Site

Follonica (GR), Tuscany, 58022, Italy

Location

GSK Investigational Site

Grosseto, Tuscany, 58100, Italy

Location

GSK Investigational Site

Lucignano (AR), Tuscany, 52046, Italy

Location

GSK Investigational Site

Orbetello (GR), Tuscany, 58015, Italy

Location

GSK Investigational Site

Sassofortino (GR), Tuscany, 58029, Italy

Location

GSK Investigational Site

Perugia, Umbria, 06125, Italy

Location

GSK Investigational Site

Perugia, Umbria, 06126, Italy

Location

GSK Investigational Site

Perugia, Umbria, Italy

Location

GSK Investigational Site

Ripa (PG), Umbria, 06134, Italy

Location

GSK Investigational Site

Alessano (LE), Italy

Location

GSK Investigational Site

Rome, 00144, Italy

Location

Related Publications (2)

• 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.

  PMID: 31193254 BACKGROUND

• 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.

  PMID: 30793003 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: February 26, 2013
• Primary Completion: October 5, 2016
• Study Completion: October 5, 2016
• Last Updated: May 22, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

IT (43)