Herpes ZosterNCT06667245
Impact on Quality of Life and Burden of Disease in Adults With Herpes Zoster
An observational study of Herpes Zoster and Quality of Life, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
Title: Impact on quality of life and disease burden in adults with herpes zoster Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3. Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster, Quality of Life, Immunization; Infection
- Type of treatment
- Vaccines
- How many people
- 357 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2024to 4 Nov 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective study: Patients > 18 years of age who are to be immunized against HZ Retrospective study: Adults over 18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation hospital. Since the international classification of diseases changed from ICD 9 to ICD 10 in 2016, the codes to be used for the inclusion of patients in the study are described below. Patients diagnosed with herpes zoster (HZ). Study Population and Total Number of Patients: Based on the sample calculation, it is intended to include a total of 357 patients in the prospective study and 1,920 patients in the retrospective study.
Who may be able to join
None listed.
Who cannot join
- Pregnant women
- Patients with altered level of consciousness (dementia and others) who do not complete the questionnaires
- Patients who do not wish to participate in the study 5.2 Retrospective cohort study Inclusion criteria Adults >18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation hospital. Since the international classification of diseases changed from ICD 9 to ICD 10 in 2106, the codes to be used for the inclusion of patients in the study are described below.
- ICD 9 053 Herpes zoster
- Includes:
- Herpes zoster
Show all 39Show fewer
- Zone 053.0 With meningitis 053.1 With other central nervous system complications
- 053.10 With unspecified nervous system complications
- 053.11 Geniculate herpes zoster or Herpetic geniculate ganglionitis
- 053.12 Postherpetic trigeminal neuralgia
- 053.13 Postherpetic polyneuropathy
- 053.14 Herpes zoster myelitis
- 053.19 Other 053.2 With ophthalmic complications
- 053.20 Herpes zoster dermatitis of eyelid or Herpes zoster ophthalmicus
- 053.21 Herpes zoster keratoconjunctivitis
- 053.22 Herpes zoster iridocyclitis zoster
- 053.29 Other 053.7 With other specific complications
- 053.71 Otitis externa due to herpes zoster
- 053.79 Other 053.8 With unspecified complications 053.9 Herpes zoster without complication Herpes zoster NOS ICD 10 B02 Herpes zoster
- Includes:
- herpes
- zona B02.0 Encephalitis due to herpes zoster Meningoencephalitis due to zoster B02.1 Meningitis due to herpes zoster B02.2 Herpes zoster with other nervous system involvement
- B02.21 Postherpetic geniculate ganglionitis
- B02.22 Postherpetic trigeminal neuralgia
- B02.23 Postherpetic polyneuropathy
- B.02.24 Myelitis Postherpetic myelitis
- B02.29 Other postherpetic nervous system involvement
- B02.3 Ocular herpes zoster
- B02.30 Ocular herpes zoster, unspecified
- B02.31 Herpes zoster conjunctivitis
- B02.32 Herpes zoster iridocyclitis
- B02.33 Herpes zoster keratitis
- B02.34 Herpes zoster scleritis
- B02.39 Other herpes zoster eye disease
- B02.7 Disseminated herpes zoster
- B02.8 Herpes zoster with other complications
- B02.9 Uncomplicated herpes zoster
- B02.39 Herpes zoster otitis externa NEOM
- Patients who are vaccinated against HZV
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
ALBA VEGA, PhD investigator, 915504800 ext. 4787, alba.vegav@quironsalud.es
About this study
Title: Impact on quality of life and disease burden in adults with herpes zoster
Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3.
Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.
Read the detailed description
Impact on quality of life and disease burden in adults with herpes zoster Contents
HYPOTHESIS AND OBJECTIVES OF THE STUDY 3.1 Hypothesis: Herpes zoster significantly affects the quality of life of those who suffer from it with a high disease burden.
3.2 Primary outcomes: To measure the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Fundación Jiménez Díaz University Hospital.
3.3 Secondary outcomes
- Evaluating the quality of life according to the location of the zoster (postherpetic neuralgia, ophthalmic zoster, etc.)
- Evaluating the effectiveness of the vaccine against herpes zoster in terms of number of episodes, severity and quality of life.
- Evaluating the economic impact and disease burden in terms of morbidity and mortality in adult with herpes zoster
TYPE OF STUDY AND DESIGN
Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3.
Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.
SUBJECT SELECTION 5.1 Prospective cohort study Inclusion criteria Patients > 18 years of age who are to be immunised against HZ
Exclusion criteria:
- Pregnant women
- Patients with altered level of consciousness (dementia and others) who do not complete the questionnaires
- Patients who do not wish to participate in the study 5.2 Retrospective cohort study Inclusion criteria
- Adults over 18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation. Since the international classification of diseases changed from ICD 9 to ICD 10 in 2016, the codes to be used for the inclusion of patients in the study are described below.
ICD 9 053 Herpes zoster Includes:
Herpes zoster Zone 053.0 With meningitis 053.1 With other central nervous system complications 053.10 With unspecified nervous system complications 053.11 Geniculate herpes zoster or Herpetic geniculate ganglionitis 053.12 Postherpetic trigeminal neuralgia 053.13 Postherpetic polyneuropathy 053.14 Herpes zoster myelitis 053.19 Other 053.2 With ophthalmic complications 053.20 Herpes zoster dermatitis of eyelid or Herpes zoster ophthalmicus 053.21 Herpes zoster keraconjunctivitis 053.22 Herpes zoster iridocyclitis 053.29 Other 053.7 With other complications specific 053.71 Otitis externa due to herpes zoster 053.79 Other 053.8 With unspecified complications 053.9 Herpes zoster without complication Herpes zoster NOS ICD 10 B02 Herpes zoster Includes: - herpes - zone B02.0 Encephalitis due to herpes zoster Meningoencephalitis due to herpes zoster B02.1 Meningitis due to herpes zoster B02.2 Herpes zoster with other nervous system involvement B02.21 Postherpetic geniculate ganglionitis B02.22 Postherpetic trigeminal neuralgia B02.23 Postherpetic polyneuropathy B.02.24 Postherpetic myelitis or Herpes zoster myelitis B02.29 Other postherpetic nervous system involvement or Postherpetic radiculopathy B02.3 Ocular herpes zoster B02.30 Ocular herpes zoster, unspecified B02.31 Herpes zoster conjunctivitis B02.32 Herpes zoster iridocyclitis B02.33 Herpes zoster keratitis or Herpes zoster keratoconjunctivitis B02.34 Herpes zoster scleritis B02.39 Other herpes zoster eye diseases or Herpes zoster blepharitis B02.7 Disseminated herpes zoster B02.8 Herpes zoster with other complications Herpes zoster otitis externa B02.9 Uncomplicated herpes zoster Herpes zoster
- Conditions
- Herpes Zoster, Quality of Life, Immunization; Infection
- Medical subject headings
- Herpes Zoster, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients > 18 years old who are going to be immunized against HZ | Patients > 18 years old who are going to be immunized against HZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.
Measuring the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.
Measured: Data will be collected for 1 year and then analyzed to respond to the outcomes
Secondary outcomes (3)
Quality of life according to the location of herpes zoster
Evaluate quality of life according to the location of herpes zoster (postherpetic neuralgia, ophthalmic zoster, etc.)
Measured: Data will be collected for 1 year and then analyzed to respond to the outcome
Effectiveness of the vaccine against herpes zoster
Evaluating the effectiveness of the herpes zoster vaccine in terms of the number of episodes, severity and quality of life.
Measured: Data will be collected for 1 year and then analyzed to respond to the objective
Economic impact and disease burden in terms of morbidity and mortality
Economic impact and burden of disease in terms of morbidity and mortality of adult patients with herpes zoster
Measured: A retrospective analysis will be carried out, when the data has been analysed this outcome will be answered, in approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start4 Nov 2024 (estimated)
- Primary completion4 Nov 2025 (estimated)
- Study completion4 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 357 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667245
- Sponsor's protocol ID
- V1.0_03.04.24
- Status last verified
- Oct 2024
- First submitted
- 9 Jul 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Quality of Life and Burden of Disease in Adults With Herpes Zoster
- ClinicalTrials.gov ID
- NCT06667245
- Acronym / sponsor ID
- V1.0_03.04.24
- Conditions
- Herpes Zoster, Quality of Life, Immunization; Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 357 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 4 Nov 2025 (estimated)
- Study completion
- 4 Nov 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: Impact on quality of life and disease burden in adults with herpes zoster
Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3.
Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.
Detailed description
Impact on quality of life and disease burden in adults with herpes zoster Contents
HYPOTHESIS AND OBJECTIVES OF THE STUDY 3.1 Hypothesis: Herpes zoster significantly affects the quality of life of those who suffer from it with a high disease burden.
3.2 Primary outcomes: To measure the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Fundación Jiménez Díaz University Hospital.
3.3 Secondary outcomes
- Evaluating the quality of life according to the location of the zoster (postherpetic neuralgia, ophthalmic zoster, etc.)
- Evaluating the effectiveness of the vaccine against herpes zoster in terms of number of episodes, severity and quality of life.
- Evaluating the economic impact and disease burden in terms of morbidity and mortality in adult with herpes zoster
TYPE OF STUDY AND DESIGN
Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3.
Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.
SUBJECT SELECTION 5.1 Prospective cohort study Inclusion criteria Patients > 18 years of age who are to be immunised against HZ
Exclusion criteria:
- Pregnant women
- Patients with altered level of consciousness (dementia and others) who do not complete the questionnaires
- Patients who do not wish to participate in the study 5.2 Retrospective cohort study Inclusion criteria
- Adults over 18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation. Since the international classification of diseases changed from ICD 9 to ICD 10 in 2016, the codes to be used for the inclusion of patients in the study are described below.
ICD 9 053 Herpes zoster Includes:
Herpes zoster Zone 053.0 With meningitis 053.1 With other central nervous system complications 053.10 With unspecified nervous system complications 053.11 Geniculate herpes zoster or Herpetic geniculate ganglionitis 053.12 Postherpetic trigeminal neuralgia 053.13 Postherpetic polyneuropathy 053.14 Herpes zoster myelitis 053.19 Other 053.2 With ophthalmic complications 053.20 Herpes zoster dermatitis of eyelid or Herpes zoster ophthalmicus 053.21 Herpes zoster keraconjunctivitis 053.22 Herpes zoster iridocyclitis 053.29 Other 053.7 With other complications specific 053.71 Otitis externa due to herpes zoster 053.79 Other 053.8 With unspecified complications 053.9 Herpes zoster without complication Herpes zoster NOS ICD 10 B02 Herpes zoster Includes: - herpes - zone B02.0 Encephalitis due to herpes zoster Meningoencephalitis due to herpes zoster B02.1 Meningitis due to herpes zoster B02.2 Herpes zoster with other nervous system involvement B02.21 Postherpetic geniculate ganglionitis B02.22 Postherpetic trigeminal neuralgia B02.23 Postherpetic polyneuropathy B.02.24 Postherpetic myelitis or Herpes zoster myelitis B02.29 Other postherpetic nervous system involvement or Postherpetic radiculopathy B02.3 Ocular herpes zoster B02.30 Ocular herpes zoster, unspecified B02.31 Herpes zoster conjunctivitis B02.32 Herpes zoster iridocyclitis B02.33 Herpes zoster keratitis or Herpes zoster keratoconjunctivitis B02.34 Herpes zoster scleritis B02.39 Other herpes zoster eye diseases or Herpes zoster blepharitis B02.7 Disseminated herpes zoster B02.8 Herpes zoster with other complications Herpes zoster otitis externa B02.9 Uncomplicated herpes zoster Herpes zoster
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients > 18 years old who are going to be immunized against HZ | – | –Patients > 18 years old who are going to be immunized against HZ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective study: Patients > 18 years of age who are to be immunized against HZ Retrospective study: Adults over 18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation hospital. Since the international classification of diseases changed from ICD 9 to ICD 10 in 2016, the codes to be used for the inclusion of patients in the study are described below. Patients diagnosed with herpes zoster (HZ). Study Population and Total Number of Patients: Based on the sample calculation, it is intended to include a total of 357 patients in the prospective study and 1,920 patients in the retrospective study.
Key inclusion criteria (0 listed)
Key exclusion criteria (39 listed)
- Pregnant women
- Patients with altered level of consciousness (dementia and others) who do not complete the questionnaires
- Patients who do not wish to participate in the study 5.2 Retrospective cohort study Inclusion criteria Adults >18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation hospital. Since the international classification of diseases changed from ICD 9 to ICD 10 in 2106, the codes to be used for the inclusion of patients in the study are described below.
- ICD 9 053 Herpes zoster
- Herpes zoster
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.
Time frame: Data will be collected for 1 year and then analyzed to respond to the outcomes
Measuring the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.
3 secondary outcomes
Quality of life according to the location of herpes zoster
Time frame: Data will be collected for 1 year and then analyzed to respond to the outcome
Effectiveness of the vaccine against herpes zoster
Time frame: Data will be collected for 1 year and then analyzed to respond to the objective
Economic impact and disease burden in terms of morbidity and mortality
Time frame: A retrospective analysis will be carried out, when the data has been analysed this outcome will be answered, in approximately 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Patil A. Goldust M. Wollina U. Herpes zoster: A Review of Clinical Manifestations and Management. Viruses. \[Internet\]. 2022. \[Consultado 18 Feb 2024\]; 14(2)Link provided by the sponsor.
- Kain A., Tizek L., Wecker H., Wallnöfer F., Biedermann T., Zink A. Evaluating public interest in herpes zoster in Germany by leveraging the internet: a retrospective search data analysis. BMC Public Health. \[Internet\]. 2023. \[Consultado 29 Mar 2024\]; 2Link provided by the sponsor.
- Masa Calles J. López Perca N. Vila Cordero B. Carmona R. Vigilancia y epidemiología del herpes zóster en España. RevEsp Salud Pública.\[Internet\]. 2021. \[Consultado 18 Feb 2024\]; 95. (e1-13).Link provided by the sponsor.
- Centro Nacional de Epidemiología. CIBERESP. Instituto de Salud Carlos III. Informe epidemiológico sobre la situación del Herpes Zóster en España. \[Internet\]. 2020. \[Consultado 18 Feb 2024\].Link provided by the sponsor.
- Patkia A., Vorab A., Parikh R., Kolhapure S., Agrawal A., Dash R. Herpes zoster in outpatient departments of healthcare centers in India: a review of literatura. Human vaccines\&immunotherapeutics. \[Internet\]. 2021. \[Consultado 29 Mar 2024\].Link provided by the sponsor.
- Ralph Tayyar R., Ho D. Herpes Simplex Virus and Varicella Zoster Virus Infections in Cancer Patients. Viruses. \[Internet\]. 2023. \[Consultado 28 Mar 2024\];15, 439.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster and Quality of Life, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital. (time frame: Data will be collected for 1 year and then analyzed to respond to the outcomes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.