Herpes ZosterNCT03903237
Herpes Zoster: Risk Factors, Complications and Special Situations
An observational study of Herpes Zoster, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This retrospective analysis is to investigate patients' history and clinical presentation in Herpes Zoster (HZ), Zoster-related complications, post-Zoster neuralgia and Herpes Zoster management in order to improve the management of HZ patients, to refine HZ-vaccination strategies and elucidate cost factors of HZ in in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- retrospective chart review
- How many people
- 355 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Dec 2018to 28 Feb 2019
- 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
- Adult, Older adult
Study population: patients with HZ who were seen at University Hospital Basel between 2004-2018
Who may be able to join
- Reports of patients with HZ at University Hospital Basel between 2004-2018
Who cannot join
- rejection to use patient data
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital Basel
Basel, 4031
About this study
Official title: Herpes Zoster: Risk Factors, Complications and Special Situations- a Retrospective Analysis
This retrospective analysis is to investigate patients' history and clinical presentation in Herpes Zoster (HZ), Zoster-related complications, post-Zoster neuralgia and Herpes Zoster management in order to improve the management of HZ patients, to refine HZ-vaccination strategies and elucidate cost factors of HZ in in the setting of a university hospital in Switzerland generally and in a dermatology department specifically.
- Conditions
- Herpes Zoster
- Being tested
- retrospective chart review
- Keywords
- post-zoster neuralgia, Herpes Zoster-related complications
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective chart reviewOther
retrospective report review of HZ patients treated between 2005 and 2018 in the Department of Dermatology at the University Hospital Basel
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patients' history
Free text evaluation of patients' history (age, sex, comorbidities, immunosuppression, obesity, human immune deficiency Virus (HIV), profession, current medication, vaccinations, seasonal occurence of HZ, history of Varicella Zoster virus (VZV) infection
Measured: single time point assessment at baseline
Description of the clinical presentation of HZ
Free text description of the clinical presentation of HZ (localisation, dermatomes affected), Zoster-related acute pain
Measured: single time point assessment at baseline
Evaluation of zoster-related complications
Free text evaluation of zoster-related complications (ophthalmic zoster, generalised HZ, Ramsay-Hunt syndrome, zoster meningoencephalitis)
Measured: single time point assessment at baseline
Evaluation of the herpes zoster management
Free text evaluation of the herpes zoster management (local (antiviral) treatment, systemic antiviral and other treatments, number of revisits, average treatment-related costs, hospitalisations (rate, duration)
Measured: single time point assessment at baseline
Assessment of post-zoster neuralgia
Free text assessment of post-zoster neuralgia (annual incidence, treatment options used)
Measured: single time point assessment at baseline
Evaluation of zoster and pregnancy
Free text evaluation of zoster and pregnancy (incidence, time of pregnancy, pregnancy outcomes and complications)
Measured: single time point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start20 Dec 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
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.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Müller, Dr. med, Principal investigator, Department of Dermatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903237
- Sponsor's protocol ID
- 2018-02270; sp19Mueller2
- Other IDs
- 2018
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herpes Zoster: Risk Factors, Complications and Special Situations- a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03903237
- Acronym / sponsor ID
- 2018-02270; sp19Mueller2
- Conditions
- Herpes Zoster
- Keywords
- post-zoster neuralgia, Herpes Zoster-related complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 4 Apr 2019 (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.
This retrospective analysis is to investigate patients' history and clinical presentation in Herpes Zoster (HZ), Zoster-related complications, post-Zoster neuralgia and Herpes Zoster management in order to improve the management of HZ patients, to refine HZ-vaccination strategies and elucidate cost factors of HZ in in the setting of a university hospital in Switzerland generally and in a dermatology department specifically.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with HZ who were seen at University Hospital Basel between 2004-2018
Key inclusion criteria (1 listed)
- Reports of patients with HZ at University Hospital Basel between 2004-2018
Key exclusion criteria (1 listed)
- rejection to use patient data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective chart reviewretrospective report review of HZ patients treated between 2005 and 2018 in the Department of Dermatology at the University Hospital Basel | Other | – |
Primary outcome
Evaluation of patients' history
Time frame: single time point assessment at baseline
Free text evaluation of patients' history (age, sex, comorbidities, immunosuppression, obesity, human immune deficiency Virus (HIV), profession, current medication, vaccinations, seasonal occurence of HZ, history of Varicella Zoster virus (VZV) infection
Description of the clinical presentation of HZ
Time frame: single time point assessment at baseline
Free text description of the clinical presentation of HZ (localisation, dermatomes affected), Zoster-related acute pain
Evaluation of zoster-related complications
Time frame: single time point assessment at baseline
Free text evaluation of zoster-related complications (ophthalmic zoster, generalised HZ, Ramsay-Hunt syndrome, zoster meningoencephalitis)
Evaluation of the herpes zoster management
Time frame: single time point assessment at baseline
Free text evaluation of the herpes zoster management (local (antiviral) treatment, systemic antiviral and other treatments, number of revisits, average treatment-related costs, hospitalisations (rate, duration)
Assessment of post-zoster neuralgia
Time frame: single time point assessment at baseline
Free text assessment of post-zoster neuralgia (annual incidence, treatment options used)
Evaluation of zoster and pregnancy
Time frame: single time point assessment at baseline
Free text evaluation of zoster and pregnancy (incidence, time of pregnancy, pregnancy outcomes and complications)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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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.
Simon Müller, Dr. med principal investigator
Department of Dermatology, University Hospital Basel
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, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Apr 2019. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of patients' history (time frame: single time point assessment at baseline). The study lists 6 primary outcomes in all. 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 4 Apr 2019.