Influenza Virus InfectionHOSPIGRIPNCT04008823
Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons
An observational study of Influenza Virus Infection, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza Virus Infection
- What is being tested?
- Retrospective and observational epidemiological study, by review of clinical histories,
- How many people
- 907 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2017to 13 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: the population under study is children under 15 years of age, hospitalized for infection with influenza virus confirmed microbiologically during two consecutive seasons (September 15, 2014 to June 30, 2015) (September 15, 2015 to June 30, 2015). 2016).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons. Analysis of Direct Medical Costs
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
Read the detailed 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
- Conditions
- Influenza Virus Infection
- Being tested
- Retrospective and observational epidemiological study, by review of clinical histories,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective and observational epidemiological study, by review of clinical histories,Other
Retrospective and observational epidemiological study, by review of clinical histories,
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2014-2016
Secondary outcomes (7)
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
Measured: 2014-2016
Demographic characteristics of hospitalizations for influenza in children
Age, sex, weight
Measured: 2014-2016
Complications associated with influenza infection.
Measured: 2014-2016
Related morbidity
Measured: 2014-2016
Estimation of direct costs
- Income costs and prescribed medication.
- Test costs.
- Bed and UCIP costs.
- Costs previous visits (to hospitalization) to the emergency room
Measured: 2014-2016
Epidemiological characteristics of hospitalizations for influenza in children
Presence or absence of seasonal influenza vaccination.
Measured: 2014-2016
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.
Measured: 2014-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start5 Oct 2017
- Primary completion2 Nov 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008823
- Sponsor's protocol ID
- HOSPIGRIP
- Acronym
- HOSPIGRIP
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons. Analysis of Direct Medical Costs
- ClinicalTrials.gov ID
- NCT04008823
- Acronym / sponsor ID
- HOSPIGRIP / HOSPIGRIP
- Conditions
- Influenza Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 907 participants (actual)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- the population under study is children under 15 years of age, hospitalized for infection with influenza virus confirmed microbiologically during two consecutive seasons (September 15, 2014 to June 30, 2015) (September 15, 2015 to June 30, 2015). 2016).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective and observational epidemiological study, by review of clinical histories,Retrospective and observational epidemiological study, by review of clinical histories, | Other | – |
Primary outcome
To study the rate of hospitalizations for influenza virus infection in children under 15 years of age in third level hospitals in Spain.
Time frame: 2014-2016
Number of hospitalizations in children under 15 years old due to influenza virus infection
7 secondary outcomes
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
Time frame: 2014-2016
Demographic characteristics of hospitalizations for influenza in children
Time frame: 2014-2016
Complications associated with influenza infection.
Time frame: 2014-2016
Related morbidity
Time frame: 2014-2016
Estimation of direct costs
Time frame: 2014-2016
Epidemiological characteristics of hospitalizations for influenza in children
Time frame: 2014-2016
Clinical characteristics of hospitalizations for influenza in children
Time frame: 2014-2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Virus Infection, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the rate of hospitalizations for influenza virus infection in children under 15 years of age in third level hospitals in Spain. (time frame: 2014-2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.