Population Based Surveillance to Estimate the Burden of Herpes Zoster and Post-herpetic Neuralgia in Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient participating in another clinical study (participation in another observational, non-interventional trial is allowed).
结局指标
主要结局
Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender
时间窗: Day 0 to 2 years
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.
次要结局
- 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)
- Other Complications Related to HZ Cases, Overall(Between Day 0 and Day 270)
- Direct Medical Costs, Direct Non-medical Costs and Indirect Costs(Up to Day 90)
- Worst Pain Assessment in HZ Subjects(At Day 90)
- Average Pain Assessment in HZ Subjects(At Day 90)
- Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory(At Day 0, 15, 30, 60, 90)
- Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits(At Day 0, 15, 30, 60, 90)
- PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective(Between Day 90 and Day 270)
- Worst Pain Assessment in PHN Subjects(At Day 90)
- Average Pain Assessment in PHN Subjects(At Day 90)
- Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory(At Day 0, 15, 30, 60, 90)
- Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits(At Day 0, 15, 30, 60, 90)