Health Condition 1: B108- Other human herpesvirus infection
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Dr Hemant P Thacker
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female more than or equal to 18 years of age 2. Symptomatic presentation of HZ [such as appearance of rash which may be in one or two dermatomes associated with pain, itchy, tingly sensation, headache, photophobia (sensitivity to bright lights), or malaise] accompanied by a prescription from a medical practitioner 3. Duration between first diagnosis of HZ and study enrolment not exceeding 10 days
Exclusion criteria
Exclusion criteria: 1. Individuals who have received Zoster vaccine 2. Patients lacking the ability to understand or the willingness to sign and date a written informed consent document 3. Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of HZ patients amongst all patients visiting the departmental OPD during the study period 2. Age-stratified distribution of HZ amongst subjects (age-groups: 18-29, 30-39, 40-49 and =50) 3. Proportion of subjects with each kind of complication (such as PHN, Herpes Zoster Ophthalmicus or HZO, bacterial superinfection, cranial and peripheral nerve palsies, visceral involvement, etc.) in outpatient 4. Proportion of subjects based on presentation of typical clinical features 5. Gender-wise distribution of HZ and HZ complications (such as PHN, Herpes Zoster Ophthalmicus or HZO, bacterial superinfection, cranial and peripheral nerve palsies, visceral involvement, etc.) amongst subjects enrolled in the study 6. Geographical distribution of HZ across study sites 7. Seasonal variation of HZ across study sites 8. Proportion of immunocompromised and immunocompetent HZ subjects Continued..Timepoint: Day 0, Day 30 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Continued.. 9. Proportion of subjects with and without comorbidities among the immunocompetent subjects 10. Age-stratified distribution of HZ complications (such as PHN, Herpes Zoster Ophthalmicus or HZO, bacterial superinfection, cranial and peripheral nerve palsies, visceral involvement, etc.) (age-groups: 18-29, 30-39, 40-49 and =50) 11. Age-stratified distribution of immunocompromised and immunocompetent HZ subjects (age-groups: 18-29, 30-39, 40-49 and =50) 12. Proportion of subjects with affected area being thoracic, cervical, cranial, lumbar, sacral, etc. 13. Proportion of subjects with multidermatomal involvement 14. Proportion of subjects requiring Zoster-associated hospitalization Continued..Timepoint: Day 0, Day 30 and Day 90;Continued.. 15. Health Care Resource Utilization (HCRU) and associated costs (direct and indirect) of HZ: a) Cost of primary and secondary care (excluding hospitalization) b) Consultation fees of treating physician and specialists, as applicable c) Total cost of hospitalization d) Total cost of diagnostic investigations e) Total cost of medicines (along with the type of medicines) f) Travel expense g) Duration of hospital stay h) Number of working hours missed by the subject and caregiver(s), as applicable Continued..Timepoint: Day 0, Day 30 and Day 90;Continued.. 16. Difference in Health Care Resource Utilization (HCRU) and associated costs in immunocompromised and immunocompetent subjects 17. Difference in Health Care Resource Utilization (HCRU) and associated costs between immunocompetent subjects with and without comorbidities 18. Zoster Brief Pain Inventory (ZBPI) score evaluated at baseline and after 1 month and 3 months from study enrollment 19. Quality of Life (QoL) assessed based on responses on the EQ-5DTimepoint: Day 0, Day 30 and Day 90 | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Bhatia Hospital
Outcome results
None listed