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

September 21, 2015 updated by: Punnee Pitisuttithum, Mahidol University

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Elderly patients
HIV infected patients
Immunosuppressed patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Punnee Pitisuttithum, Professor, Department of Clinical Tropical Medicine, Faculty of Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUTM2007-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Herpes Zoster

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe