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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2019
Source Asociacion Instituto Biodonostia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

A better knowledge in our environment of the characteristics of the Influenza virus infection in the pediatric age, the clinical aspects, risk factors, the evolutionary and prognostic aspects, of morbidity and the direct medical costs, can allow a better management of the disease and a greater awareness of the importance of vaccination against influenza in the healthy child


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
Retrospective and observational epidemiological study, by review of clinical histories,
Retrospective and observational epidemiological study, by review of clinical histories,

Locations

Country Name City State
Spain Iis Biodonostia San Sebastián Guipuzcoa

Sponsors (1)

Lead Sponsor Collaborator
Asociacion Instituto Biodonostia

Country where clinical trial is conducted

Spain, 

Outcome

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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