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Measuring Herpes Zoster and PHN Associated Burden of Illness and Health Care Utilization Costs in Thailand

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00526864
First Posted: September 10, 2007
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University
  Purpose

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

Condition
Herpes Zoster

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Herpes Zoster and Post-Herpetic Neuralgia Associated Burden of Illness and Health Care Utilization and Costs in Thailand

Resource links provided by NLM:


Further study details as provided by Punnee Pitisuttithum, Mahidol University:

Enrollment: 180
Study Start Date: May 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elderly patients
HIV infected patients
Immunosuppressed patients

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • no specific exclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526864


Locations
Thailand
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Punnee Pitisuttithum, Professor Department of Clinical Tropical Medicine, Faculty of Tropical Medicine
  More Information

Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT00526864     History of Changes
Other Study ID Numbers: MUTM2007-035
First Submitted: September 7, 2007
First Posted: September 10, 2007
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Punnee Pitisuttithum, Mahidol University:
Burden of Illness for Herpes zoster in Thailand.

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases