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

NCT ID: NCT00526864

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-07-31

Brief 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

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.

Conditions

Herpes Zoster

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Elderly patients

No interventions assigned to this group

HIV infected patients

No interventions assigned to this group

Immunosuppressed patients

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Punnee Pitisuttithum

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Punnee Pitisuttithum, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine

Locations

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

MUTM2007-035

Identifier Type: -

Identifier Source: org_study_id