- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00526864
Measuring Herpes Zoster and PHN Associated Burden of Illness and Health Care Utilization Costs in Thailand
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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Bangkok, Thailand, 10400
- Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Eldre pasienter
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HIV infected patients
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Immunosuppressed patients
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Punnee Pitisuttithum, Professor, Department of Clinical Tropical Medicine, Faculty of Tropical Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MUTM2007-035
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