Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526864
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2007-09-07
Brief Title:
Measuring Herpes Zoster and PHN Associated Burden of Illness and Health Care Utilization Costs in Thailand
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Measuring Herpes Zoster and Post-Herpetic Neuralgia Associated Burden of Illness and Health Care Utilization and Costs in Thailand
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Total 7 institutions will be recruited ie Clinical Infectious Disease Research Unit Department of Clinical Tropical Medicine Faculty of Tropical Medicine Mahidol UniversityBamrasnaradura Infectious Disease Institute
Pramonkutklao HospitalRajavithi HospitalNationalCancerInstituteInstitute of DermatologyRaj 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
Pramonkutklao HospitalRajavithi HospitalNationalCancerInstituteInstitute of DermatologyRaj 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 investigators 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
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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None