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
  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: Defined Population
Time Perspective: Cross-Sectional
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 Mahidol University:

Estimated Enrollment: 75
Study Start Date: May 2007
Estimated Study Completion Date: June 2008
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526864

Contacts
Contact: Punnee Pitisuttithum, Professor 662-643-5599 tmppt@mahidol.ac.th
Contact: Valai Bussaratid, M.D. 662-643-5599 tmvbs@mahidol.ac.th

Locations
Thailand
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University Recruiting
Bangkok, Thailand, 10400
Contact: Punnee Pitisuttithum, Professor    662-643-5599    tmppt@mahidol.ac.th   
Contact: Valai Bussaratid, M.D.    662-643-5599    tmvbs@mahidol.ac.th   
Principal Investigator: Punnee Pitisuttithum, Professor         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Punnee Pitisuttithum, Professor Department of Clinical Tropical Medicine, Faculty of Tropical Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00526864     History of Changes
Other Study ID Numbers: MUTM2007-035
Study First Received: September 7, 2007
Last Updated: September 7, 2007
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia, Postherpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014