Herpes ZosterNCT00526864
Measuring Herpes Zoster and PHN Associated Burden of Illness and Health Care Utilization Costs in Thailand
An observational study of Herpes Zoster, run by Mahidol University at 1 site in Thailand.
Trial summary
Total 7 institutions will be recruited i.e. Clinical Infectious Disease Research Unit Department of Clinical Tropical Medicine, Faculty of Tropical Medicine Mahidol University,Bamrasnaradura Infectious Disease Institute ,Pramonkutklao Hospital,Rajavithi Hospital,NationalCancerInstitute,Institute of Dermatology,Raj… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Herpes Zoster
- How many people
- 180 participants
- Where
- 1 siteThailand
- Study dates
- May 2007to Jul 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: total of 180 clinically diagnosed herpes zoster patients, either aged ‡ 50 years and otherwise healthy, or ‡ 20 years with HIV infection, or ‡ 20 years and currently receiving chemotherapy or immunosuppressive agents.
Who may be able to join
- Physician confirmed diagnosis of Zoster rash
- of onset of Zoster rash must be documented in the patient's chart.
- Patient is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent.
- Patient will be available for the study follow up period
Who cannot join
- no specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
Bangkok, Bangkok, 10400
About this study
Official title: Measuring Herpes Zoster and Post-Herpetic Neuralgia Associated Burden of Illness and Health Care Utilization and Costs in Thailand
Total 7 institutions will be recruited i.e. Clinical Infectious Disease Research Unit Department of Clinical Tropical Medicine, Faculty of Tropical Medicine Mahidol University,Bamrasnaradura Infectious Disease Institute
,Pramonkutklao Hospital,Rajavithi Hospital,NationalCancerInstitute,Institute of Dermatology,Raj Pracha Samasai Institute
Read more
OBJECTIVES
- Measure the burden of illness due to herpes zoster (Zoster) and post-herpetic neuralgia (PHN) (severity and duration);
- Assess the quality of life (QoL) and quality adjusted life years (QALY) lost due to Zoster and PHN;
- Describe health care resource utilization associated with Zoster and PHN;
- Describe the direct and indirect costs per case of Zoster and PHN
Read the detailed description
This will be a prospective cohort study of patients presenting with Zoster rash in 7 specialized institutions in Thailand.
Subjects will be entered in the cohort at the time of presentation with Zoster rash. After the baseline assessment (day 0) that will be conducted at the investigator's office there will be 4 assessments (prospective part of the study) that will be conducted at day 7, month 1, month 3 and month 6.
We expect that there will be approximately 150 patients included in the study cohort. Cohort assembly will take place between April 2007 and October 2007.
The study will be conducted in 3 groups
Eligible patients for each group will include
- Group A: Both male and female patients ≥ 50 years of age with Zoster rash.
- Group B: Both HIV infected male and female patients ≥ 20 years of age with Zoster rash.
- Group C: Both Oncology male and female patients ≥ 20 years of age who on chemotherapy with Zoster rash.
Key exclusion criteria includes patient who refuses to sign informed consent.
- Conditions
- Herpes Zoster
- Keywords
- Burden of Illness for Herpes zoster in Thailand.
- Medical subject headings
- Herpes Zoster
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 |
|---|---|---|
| Elderly patients | Not described | |
| HIV infected patients | Not described | |
| Immunosuppressed patients | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJul 2008
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 Mahidol UniversityThe 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
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Punnee Pitisuttithum, Mahidol University
- Investigators
- Punnee Pitisuttithum, Professor, Principal investigator, Department of Clinical Tropical Medicine, Faculty of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526864
- Sponsor's protocol ID
- MUTM2007-035
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2007
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Herpes Zoster and Post-Herpetic Neuralgia Associated Burden of Illness and Health Care Utilization and Costs in Thailand
- ClinicalTrials.gov ID
- NCT00526864
- Acronym / sponsor ID
- MUTM2007-035
- Conditions
- Herpes Zoster
- Keywords
- Burden of Illness for Herpes zoster in Thailand.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Sep 2007 (estimated)
- 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.
Total 7 institutions will be recruited i.e. Clinical Infectious Disease Research Unit Department of Clinical Tropical Medicine, Faculty of Tropical Medicine Mahidol University,Bamrasnaradura Infectious Disease Institute
,Pramonkutklao Hospital,Rajavithi Hospital,NationalCancerInstitute,Institute of Dermatology,Raj Pracha Samasai Institute
OBJECTIVES
- Measure the burden of illness due to herpes zoster (Zoster) and post-herpetic neuralgia (PHN) (severity and duration);
- Assess the quality of life (QoL) and quality adjusted life years (QALY) lost due to Zoster and PHN;
- Describe health care resource utilization associated with Zoster and PHN;
- Describe the direct and indirect costs per case of Zoster and PHN
Detailed description
This will be a prospective cohort study of patients presenting with Zoster rash in 7 specialized institutions in Thailand.
Subjects will be entered in the cohort at the time of presentation with Zoster rash. After the baseline assessment (day 0) that will be conducted at the investigator's office there will be 4 assessments (prospective part of the study) that will be conducted at day 7, month 1, month 3 and month 6.
We expect that there will be approximately 150 patients included in the study cohort. Cohort assembly will take place between April 2007 and October 2007.
The study will be conducted in 3 groups
Eligible patients for each group will include
- Group A: Both male and female patients ≥ 50 years of age with Zoster rash.
- Group B: Both HIV infected male and female patients ≥ 20 years of age with Zoster rash.
- Group C: Both Oncology male and female patients ≥ 20 years of age who on chemotherapy with Zoster rash.
Key exclusion criteria includes patient who refuses to sign informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | – | – |
| HIV infected patients | – | – |
| Immunosuppressed patients | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- total of 180 clinically diagnosed herpes zoster patients, either aged ‡ 50 years and otherwise healthy, or ‡ 20 years with HIV infection, or ‡ 20 years and currently receiving chemotherapy or immunosuppressive agents.
Key inclusion criteria (4 listed)
- Physician confirmed diagnosis of Zoster rash
- of onset of Zoster rash must be documented in the patient's chart.
- Patient is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent.
- Patient will be available for the study follow up period
Key exclusion criteria (1 listed)
- no specific exclusion criteria
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
Not reported in the source record.
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 23 Sep 2015.
Related trials for Herpes Zoster
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
Active, not recruitingPhase 2
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
Herpes Zoster
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.
Punnee Pitisuttithum, Professor principal investigator
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine
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 Mahidol University at 1 site in Thailand.
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 4 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 23 Sep 2015. 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 Thailand. 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.
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 23 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.