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临床试验/NCT05952271
NCT05952271招募中不适用

Nationwide Retrospective Observational Study of Herpes Zoster Associated Hospital Admissions in Italy

University of L'Aquila1 个研究点 分布在 1 个国家目标入组 72,000 人开始时间: 2023年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72,000
试验地点
1
主要终点
Co-morbidities among Herpes Zoster hospitalizations

研究概览

简要总结

In Italy, the 2017-2019 National Immunization Plan recommended specific vaccinations for the elderly, defined as those 65 years old and older, and at-risk adults with age 50+ (adults presenting cardiovascular, respiratory, or metabolic diseases, immunodepression, etc.). However, the coverage target set by the Plan (50% for Herpes Zoster vaccination in 2019) was not reached.

Providing additional data on the incidence of Herpes Zoster could improve the risks perception of the disease and the vaccination uptake. The present study will aim to describe a full picture of Herpes Zoster associated hospital admissions in Italy, focusing on co-morbidities which induce reduced varicella-zoster virus-specific cell-mediated immunity response. Furthermore, as varicella-zoster virus reactivation was reported in COVID-19-positive patients, a deepening on a possible relationship between the two infections will be investigated.

详细描述

Varicella (chickenpox) is a highly contagious illness sustained by an α Herpes virus called varicella-zoster virus (VZV). A replication phase in the penetration site is followed by a viremic phase when VZV spreads to skin and mucosae, leading to the typical rash and infection of sensory nerves in the epithelium, and then the reach of the sensory ganglia where it becomes latent. The reactivation of the latent virus, years or decades after primary infection, causes the typical clinical expression called Herpes Zoster (HZ) or shingles.

Post-herpetic neuralgia (PHN), an intractable pain in the dermatome affected by HZ, is the most common complication. It is estimated that it affects 10-20% of all patients with HZ aged ≥ 50 years and up to 30% of those aged ≥80 years. Management of PHN is not easy, but vaccination for prevention of PHN may be a strategic choice.

The most common complications of herpes zoster, other than PHN, often requiring hospitalization, include secondary bacterial infections, ophthalmic complications, cranial and peripheral nerve palsies, and segmental zoster paresis.

All authors agree that factors such as age, cell-mediated immunity (CMI) depression, intrauterine exposure to VZV and varicella occurring in early age (<18 months) are typically associated with HZ incidence. It further should be noted that age and CMI depression are strictly related since increasing age leads to CMI decrease. An increased incidence of hospitalization for HZ among patients aged >72 years (0.46/1000-person year), compared to those aged 15-44 years (0.03/1000-person year) was reported, suggesting that aging is also a risk factor for HZ requiring hospitalization. Besides age, HZ risk can be related to other co-morbidities, including diabetes, major depression or immunosuppressive therapies, that induce reduced VZV-specific CMI response. Immunosuppressed patients are within the high-risk group, with increasing morbidity and mortality associated with herpes zoster. Immunosuppression may be associated with malignancy (especially hematological), human immunodeficiency virus (HIV) infection or medications used for organ transplantation or autoimmune disease.

HZ incidence is similar all over the world and its trend is related to population age, with two thirds of the cases affecting subjects aged >50 years.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospital discharge records for Herpes Zoster infection in primary diagnosis age ≥18 years
  • Hospital discharge records for Herpes Zoster infection in secondary diagnoses age ≥18 years

排除标准

  • Hospital discharge records for Herpes Zoster infection in primary diagnosis age <18 years
  • Hospital discharge records for Herpes Zoster infection in secondary diagnoses age <18 years

结局指标

主要结局

Co-morbidities among Herpes Zoster hospitalizations

时间窗: 2011-2021

Rate of patients hospitalized for Herpes Zoster with co-morbidities

次要结局

  • Shingles hospitalization rates by age classes(2011-2021)
  • Shingles annual hospitalization rates(2011-2021)
  • Risk factors associated to deaths, a longer length of stay in hospital or the presence of zoster-complications among Herpes Zoster-related hospitalizations in the entire Italian general adult population(2011-2021)
  • Herpes Zoster and COVID-19 infection(2020-2021)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonella Mattei

Associate Professor

University of L'Aquila

研究点 (1)

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