Hospital-Acquired InfectionNOSOGRIPPENCT03413228
Nosocomial Influenza Surveillance 2018 - 2022
An observational study of Hospital-Acquired Infection and Influenza, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals. The transmission of influenza has been mostly reported in pediatric and long-stay units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-Acquired Infection, Influenza
- What is being tested?
- Questionnaire
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2018to Jun 2022
- 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
- Adult, Older adult
Study population: Each patient or health-care worker who present ILI (influenza-like illness) at admission or during hospitalization. ILI is defined by fever > 37,8°C or/and cough or sore throat.
Who may be able to join
- Adult patients and health-care workers in a participating unit in the study,
- more than 18 years old,
- volunteers,
- who present an influenza-like illness defined by fever > 37,8°C or/and cough or sore throat.
Who cannot join
- -Everyone who does not present the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
France1 site
Infection Control unit. Edouard Herriot hospital Lyon - France
Lyon, 69003
Philippe VANHEMS, MD PhD, 0472110719 ext. +33, philippe.vanhems@chu-lyon.fr
About this study
Official title: Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France.
Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals.
The transmission of influenza has been mostly reported in pediatric and long-stay units. The chains of transmission of influenza in acute-stay units have to be describe in order to prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be important in order to identify potential sources of virus as soon as possible and to set up appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired influenza has to be harmonized for all over the studies, especially concerning the delay between the admission in the hospital and the symptoms onset.
The aim of this study is to describe the hospital-acquired influenza in a french university hospital of around 800 beds
- Conditions
- Hospital-Acquired Infection, Influenza
- Being tested
- Questionnaire
- Medical subject headings
- Cross Infection, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
An interview to collect some informations will be done: demographic informations, medical history, vaccination against influenza status, symptoms and virological informations. Then, a nasal swab was performed in order to identified the influenza virus.
| Study group | Role | What they receive |
|---|---|---|
| Influenza-like illness group | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients and health-care workers who present an influenza illness.
An interview to collect some informations will be done to evaluate if participants present symptoms of an inflenza illness (fever > 37,8°C or/and cough or sore throat).
Then, a nasal swab will be performed in order to identified the influenza virus.
Measured: 5 days maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study startFeb 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-Acquired InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413228
- Sponsor's protocol ID
- 69HCL17_0868
- Acronym
- NOSOGRIPPE
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2018
- Last updated
- 30 Jan 2018
- 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 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France.
- ClinicalTrials.gov ID
- NCT03413228
- Acronym / sponsor ID
- NOSOGRIPPE / 69HCL17_0868
- Conditions
- Hospital-Acquired Infection, Influenza
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 29 Jan 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.
Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals.
The transmission of influenza has been mostly reported in pediatric and long-stay units. The chains of transmission of influenza in acute-stay units have to be describe in order to prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be important in order to identify potential sources of virus as soon as possible and to set up appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired influenza has to be harmonized for all over the studies, especially concerning the delay between the admission in the hospital and the symptoms onset.
The aim of this study is to describe the hospital-acquired influenza in a french university hospital of around 800 beds
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza-like illness group | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Each patient or health-care worker who present ILI (influenza-like illness) at admission or during hospitalization. ILI is defined by fever > 37,8°C or/and cough or sore throat.
Key inclusion criteria (4 listed)
- Adult patients and health-care workers in a participating unit in the study,
- more than 18 years old,
- volunteers,
- who present an influenza-like illness defined by fever > 37,8°C or/and cough or sore throat.
Key exclusion criteria (1 listed)
- -Everyone who does not present the inclusion criteria.
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 |
|---|---|---|
| QuestionnaireAn interview to collect some informations will be done: demographic informations, medical history, vaccination against influenza status, symptoms and virological informations. Then, a nasal swab was performed in order to identified the influenza virus. | Other | Influenza-like illness group |
Primary outcome
Proportion of patients and health-care workers who present an influenza illness.
Time frame: 5 days maximum
An interview to collect some informations will be done to evaluate if participants present symptoms of an inflenza illness (fever > 37,8°C or/and cough or sore throat). Then, a nasal swab will be performed in order to identified the influenza virus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- 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.
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 Hospital-Acquired Infection and Influenza, run by Hospices Civils de Lyon 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe VANHEMS, MD PhD (0472110719 ext. +33, philippe.vanhems@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients and health-care workers who present an influenza illness. (time frame: 5 days maximum). 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 30 Jan 2018.