Herpes Zoster Clinical Trial
Official title:
Nationwide Retrospective Observational Study of Herpes Zoster Associated Hospital Admissions in Italy
NCT number | NCT05952271 |
Other study ID # | 14112 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 26, 2023 |
Est. completion date | July 30, 2025 |
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.
Status | Recruiting |
Enrollment | 72000 |
Est. completion date | July 30, 2025 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | University of L'Aquila | L'Aquila |
Lead Sponsor | Collaborator |
---|---|
University of L'Aquila | GlaxoSmithKline |
Italy,
Calabro GE, Tognetto A, Carini E, Mancinelli S, Sarnari L, Colamesta V, Ricciardi W, de Waure C. Strategies to Improve Vaccination among At-Risk Adults and the Elderly in Italy. Vaccines (Basel). 2020 Jul 4;8(3):358. doi: 10.3390/vaccines8030358. — View Citation
Di Legami V, Gianino MM, Ciofi degli Atti M, Massari M, Migliardi A, Tomba GS, Zotti C; Zoster Study Group. Epidemiology and costs of herpes zoster: background data to estimate the impact of vaccination. Vaccine. 2007 Oct 23;25(43):7598-604. doi: 10.1016/j.vaccine.2007.07.049. Epub 2007 Aug 15. — View Citation
Diez-Domingo J, Weinke T, Garcia de Lomas J, Meyer CU, Bertrand I, Eymin C, Thomas S, Sadorge C. Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged >/=50 years: a randomised non-inferiority clinical trial. Vaccine. 2015 Feb 4;33(6):789-95. doi: 10.1016/j.vaccine.2014.12.024. Epub 2014 Dec 30. — View Citation
Esteban-Vasallo MD, Dominguez-Berjon MF, Gil-Prieto R, Astray-Mochales J, Gil de Miguel A. Sociodemographic characteristics and chronic medical conditions as risk factors for herpes zoster: a population-based study from primary care in Madrid (Spain). Hum Vaccin Immunother. 2014;10(6):1650-60. doi: 10.4161/hv.28620. Epub 2014 May 7. — View Citation
Fiasca F, Necozione S, Fabiani L, Mastrodomenico M, Mattei A. Measles-Related Hospitalizations in Italy, 2004-2016: The Importance of High Vaccination Coverage. Ann Glob Health. 2019 Mar 19;85(1):40. doi: 10.5334/aogh.2455. — View Citation
Gabutti G, Franco E, Bonanni P, Conversano M, Ferro A, Lazzari M, Maggi S, Rossi A, Scotti S, Vitale F, Volpi A, Greco D. Reducing the burden of Herpes Zoster in Italy. Hum Vaccin Immunother. 2015;11(1):101-7. doi: 10.4161/hv.34363. Epub 2014 Nov 1. — View Citation
Gabutti G, Serenelli C, Cavallaro A, Ragni P. Herpes zoster associated hospital admissions in Italy: review of the hospital discharge forms. Int J Environ Res Public Health. 2009 Sep;6(9):2344-53. doi: 10.3390/ijerph6092344. Epub 2009 Sep 2. — View Citation
Gialloreti LE, Merito M, Pezzotti P, Naldi L, Gatti A, Beillat M, Serradell L, di Marzo R, Volpi A. Epidemiology and economic burden of herpes zoster and post-herpetic neuralgia in Italy: a retrospective, population-based study. BMC Infect Dis. 2010 Aug 3;10:230. doi: 10.1186/1471-2334-10-230. — View Citation
Grose C. Varicella vaccination of children in the United States: assessment after the first decade 1995-2005. J Clin Virol. 2005 Jun;33(2):89-95; discussion 96-8. doi: 10.1016/j.jcv.2005.02.003. — View Citation
Humphries KH, Rankin JM, Carere RG, Buller CE, Kiely FM, Spinelli JJ. Co-morbidity data in outcomes research: are clinical data derived from administrative databases a reliable alternative to chart review? J Clin Epidemiol. 2000 Apr;53(4):343-9. doi: 10.1016/s0895-4356(99)00188-2. — View Citation
Kim YJ, Lee CN, Lee MS, Lee JH, Lee JY, Han K, Park YM. Recurrence Rate of Herpes Zoster and Its Risk Factors: a Population-based Cohort Study. J Korean Med Sci. 2018 Dec 20;34(2):e1. doi: 10.3346/jkms.2019.34.e1. eCollection 2019 Jan 14. — View Citation
Koshy E, Mengting L, Kumar H, Jianbo W. Epidemiology, treatment and prevention of herpes zoster: A comprehensive review. Indian J Dermatol Venereol Leprol. 2018 May-Jun;84(3):251-262. doi: 10.4103/ijdvl.IJDVL_1021_16. — View Citation
Nardone A, de Ory F, Carton M, Cohen D, van Damme P, Davidkin I, Rota MC, de Melker H, Mossong J, Slacikova M, Tischer A, Andrews N, Berbers G, Gabutti G, Gay N, Jones L, Jokinen S, Kafatos G, de Aragon MV, Schneider F, Smetana Z, Vargova B, Vranckx R, Miller E. The comparative sero-epidemiology of varicella zoster virus in 11 countries in the European region. Vaccine. 2007 Nov 7;25(45):7866-72. doi: 10.1016/j.vaccine.2007.07.036. Epub 2007 Aug 8. — View Citation
Nimmo A, Steenkamp R, Ravanan R, Taylor D. Do routine hospital data accurately record comorbidity in advanced kidney disease populations? A record linkage cohort study. BMC Nephrol. 2021 Mar 17;22(1):95. doi: 10.1186/s12882-021-02301-5. — View Citation
Pinchinat S, Cebrian-Cuenca AM, Bricout H, Johnson RW. Similar herpes zoster incidence across Europe: results from a systematic literature review. BMC Infect Dis. 2013 Apr 10;13:170. doi: 10.1186/1471-2334-13-170. — View Citation
Stein AN, Britt H, Harrison C, Conway EL, Cunningham A, Macintyre CR. Herpes zoster burden of illness and health care resource utilisation in the Australian population aged 50 years and older. Vaccine. 2009 Jan 22;27(4):520-9. doi: 10.1016/j.vaccine.2008.11.012. Epub 2008 Nov 21. — View Citation
Tartari F, Spadotto A, Zengarini C, Zanoni R, Guglielmo A, Adorno A, Valzania C, Pileri A. Herpes zoster in COVID-19-positive patients. Int J Dermatol. 2020 Aug;59(8):1028-1029. doi: 10.1111/ijd.15001. Epub 2020 Jun 12. No abstract available. — View Citation
Thomas SL, Hall AJ. What does epidemiology tell us about risk factors for herpes zoster? Lancet Infect Dis. 2004 Jan;4(1):26-33. doi: 10.1016/s1473-3099(03)00857-0. — View Citation
Valente N, Cocchio S, Stefanati A, Baldovin T, Martinelli D, Prato R, Baldo V, Gabutti G. Temporal trends in herpes zoster-related hospitalizations in Italy, 2001-2013: differences between regions that have or have not implemented varicella vaccination. Aging Clin Exp Res. 2017 Aug;29(4):771-779. doi: 10.1007/s40520-017-0782-z. Epub 2017 Jun 12. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Co-morbidities among Herpes Zoster hospitalizations | Rate of patients hospitalized for Herpes Zoster with co-morbidities | 2011-2021 | |
Secondary | Shingles annual hospitalization rates | Shingles annual hospitalization rates in the Italian adult population aged 18+ | 2011-2021 | |
Secondary | Shingles hospitalization rates by age classes | Shingles hospitalization rates by age classes:18-30; 31-40; 41-50; >50 | 2011-2021 | |
Secondary | Herpes Zoster and COVID-19 infection | Proportion of patients with HZ vs. patients with HZ and COVID-19 infection | 2020-2021 | |
Secondary | 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 | Incidence Rate Ratio (IRR) of deaths, longer length of stay in hospital or presence of zoster-complications among Herpes Zoster-related hospitalizations in the entire Italian general adult population | 2011-2021 |
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