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

Herpes Zoster Clinical Trial

Official title:

Measuring Herpes Zoster and Post-Herpetic Neuralgia Associated Burden of Illness and Health Care Utilization and Costs in Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526864
• Other study ID #: MUTM2007-035
• Status: Completed
• Phase: N/A
• First received: September 7, 2007
• Last updated: September 21, 2015
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: September 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Herpes Zoster

Locations

Country	Name	City	State
Thailand	Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand,