InfluenzaGIVRENCT03757546
Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections
An observational study of Influenza and Respiratory Virus Syncitial, run by Poitiers University Hospital at 1 site in France.
Trial summary
The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Respiratory Virus Syncitial, Extra-respiratory
- What is being tested?
- observational
- How many people
- 252 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2018to 14 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults hospitalized with flu or RSV infections
Who may be able to join
- Hospitalized adults ≥18 years old
- Flu or RSV infection confirmed by multiplex qPCR on nasal swab
- Oral non-opposition
Who cannot join
- No health insurance
- Co-infection with viruses other than influenza or RSV
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital.
Read the detailed description
Influenza virus and Respiratory Syncitial Virus (RSV) could be responsible for severe infections. Although flu was primarily considered as limited to the respiratory system, clinical reports suggest its association with organ involvement outside of the respiratory tract.
The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.
- Conditions
- Influenza, Respiratory Virus Syncitial, Extra-respiratory
- Being tested
- observational
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation frequency of extra-respiratory manifestations with clinical, biological and radiological data
- Clinical data (clinical examination)
- Biological Data (blood test)
- Radiological data
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start3 Dec 2018
- Primary completion14 Mar 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757546
- Sponsor's protocol ID
- GIVRE
- Acronym
- GIVRE
- Status last verified
- Feb 2020
- First submitted
- 17 Oct 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections
- ClinicalTrials.gov ID
- NCT03757546
- Acronym / sponsor ID
- GIVRE / GIVRE
- Conditions
- Influenza, Respiratory Virus Syncitial, Extra-respiratory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 29 Nov 2018 (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.
The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital.
Detailed description
Influenza virus and Respiratory Syncitial Virus (RSV) could be responsible for severe infections. Although flu was primarily considered as limited to the respiratory system, clinical reports suggest its association with organ involvement outside of the respiratory tract.
The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults hospitalized with flu or RSV infections
Key inclusion criteria (3 listed)
- Hospitalized adults ≥18 years old
- Flu or RSV infection confirmed by multiplex qPCR on nasal swab
- Oral non-opposition
Key exclusion criteria (2 listed)
- No health insurance
- Co-infection with viruses other than influenza or RSV
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 |
|---|---|---|
| observationalThe aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital. | Other | – |
Primary outcome
Evaluation frequency of extra-respiratory manifestations with clinical, biological and radiological data
Time frame: at 1 month
* Clinical data (clinical examination) * Biological Data (blood test) * Radiological data
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 7 Feb 2020.
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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 and Respiratory Virus Syncitial, run by Poitiers University Hospital at 1 site in France.
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 3 inclusion and 2 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 7 Feb 2020. 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 France. 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?
Evaluation frequency of extra-respiratory manifestations with clinical, biological and radiological data (time frame: at 1 month). 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 7 Feb 2020.