N/A
Completed N=394
Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy
Herpes Zoster · Herpes Zoster Vaccine
Source: ClinicalTrials.gov NCT01772160 ↗
Enrolled (actual)
394
Serious AEs
—
Results posted
May 2020
Primary outcomePrimary: Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender — 5.19; 6.29; 5.00; 9.19 Number of HZ cases/1000 person-years
Summary
The purpose of this study is to collect data on the incidence, complications, economic burden and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender |
5.19; 6.29; 5.00; 9.19; 7.51; 10.72 | — |
| SECONDARY Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall |
11.66; 42.86; 75.00 | — |
| SECONDARY General Medical History of Cases With HZ, Overall |
32.74; 67.26; 0.00; 3.91; 35.94; 4.69 | — |
| SECONDARY Other General Medical History Characteristics for HZ Cases, Overall |
3.13; 3.13; 3.13; 3.13; 3.13; 3.13 | — |
| SECONDARY Clinical Information of Cases With HZ, Overall |
73.66; 26.34; 82.64; 5.90; 29.17; 0.35 | — |
| SECONDARY Complications Related to HZ Cases, Overall |
44.62; 7.69; 0.00; 10.77; 0.00; 4.62 | — |
| SECONDARY Other Complications Related to HZ Cases, Overall |
20.00; 20.00; 20.00; 20.00; 20.00 | — |
| SECONDARY Direct Medical Costs, Direct Non-medical Costs and Indirect Costs |
189; 2124; 82; 13; 297 | — |
| SECONDARY Worst Pain Assessment in HZ Subjects |
0.7 | — |
| SECONDARY Average Pain Assessment in HZ Subjects |
0.5 | — |
| SECONDARY Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory |
3.478; 2.742; 1.823; 1.026; 0.578 | — |
| SECONDARY Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits |
0.748; 0.801; 0.849; 0.901; 0.935 | — |
| SECONDARY PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective |
176; 426 | — |
| SECONDARY Worst Pain Assessment in PHN Subjects |
5.7 | — |
| SECONDARY Average Pain Assessment in PHN Subjects |
4.2 | — |
| SECONDARY Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory |
5.967; 6.062; 5.553; 4.315; 3.671 | — |
| SECONDARY Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits |
0.592; 0.582; 0.542; 0.688; 0.732 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female ≥ 50 years of age at the time of study enrolment presenting with acute HZ.
- HZ diagnosis for this HZ episode:
- Is his/her first outpatient diagnosis (i.e. initial consultation), OR
- Took place at another site/centre (e.g. emergency room or Dermatologist/Specialist practice) provided the HZ diagnosis is not more than 7 days before the initial visit for the present study (i.e. secondary consultation).
- Written informed consent obtained from the patient.
- Ability to comply with study procedures.
Exclusion Criteria
- Patient participating in another clinical study (participation in another observational, non-interventional trial is allowed).
Data sourced from ClinicalTrials.gov (NCT01772160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.