Influenza Virus Infection Clinical Trial
— HOSPIGRIPOfficial title:
Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons. Analysis of Direct Medical Costs
| NCT number | NCT04008823 |
| Other study ID # | HOSPIGRIP |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 5, 2017 |
| Est. completion date | December 13, 2017 |
| Verified date | July 2019 |
| Source | Asociacion Instituto Biodonostia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is an epidemiological, retrospective and observational study, by reviewing clinical histories, of children hospitalized for influenza virus infection, their comorbidities and the treatments that have been performed
| Status | Completed |
| Enrollment | 907 |
| Est. completion date | December 13, 2017 |
| Est. primary completion date | November 2, 2017 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Boys and girls under 15 years of age. - With a clinical diagnosis of influenza virus infection. - With infection by influenza virus confirmed microbiologically. - Hospitalized more than 24 hours Exclusion Criteria: - Age equal to or greater than 15 years. - That the clinical diagnosis is not influenza virus infection. - Influenza virus not confirmed by microbiological diagnosis. - Not hospitalized or hospitalized for less than 24 hours. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Iis Biodonostia | San Sebastián | Guipuzcoa |
| Lead Sponsor | Collaborator |
|---|---|
| Asociacion Instituto Biodonostia |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To study the rate of hospitalizations for influenza virus infection in children under 15 years of age in third level hospitals in Spain. | Number of hospitalizations in children under 15 years old due to influenza virus infection | 2014-2016 | |
| Secondary | Hospitalization rate by age groups (0-6 months, 6 months to 24 months, 2 to 6 years, 6 to 10 years and 10 to 15 years of age | 2014-2016 | ||
| Secondary | Demographic characteristics of hospitalizations for influenza in children | Age, sex, weight | 2014-2016 | |
| Secondary | Complications associated with influenza infection. | 2014-2016 | ||
| Secondary | Related morbidity | 2014-2016 | ||
| Secondary | Estimation of direct costs | Income costs and prescribed medication. Test costs. Bed and UCIP costs. Costs previous visits (to hospitalization) to the emergency room |
2014-2016 | |
| Secondary | Epidemiological characteristics of hospitalizations for influenza in children | Presence or absence of seasonal influenza vaccination. | 2014-2016 | |
| Secondary | Clinical characteristics of hospitalizations for influenza in children | Presence / absence in microbiological analysis of influenza virus. Coinfections. Presence or absence of complications during hospitalization. Variables of clinical evolution. Analytical variables. |
2014-2016 |
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