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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00526864
First received: September 7, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted

September 7, 2007
September 7, 2007
May 2007
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No Changes Posted
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Measuring Herpes Zoster and PHN Associated Burden of Illness and Health Care Utilization Costs in Thailand
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

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

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.
Observational
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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Herpes Zoster
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
June 2008
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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
Both
20 Years and older
No
Contact: Punnee Pitisuttithum, Professor 662-643-5599 tmppt@mahidol.ac.th
Contact: Valai Bussaratid, M.D. 662-643-5599 tmvbs@mahidol.ac.th
Thailand
 
NCT00526864
MUTM2007-035
No
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Mahidol University
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Principal Investigator: Punnee Pitisuttithum, Professor Department of Clinical Tropical Medicine, Faculty of Tropical Medicine
Mahidol University
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP