Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nosocomial Influenza Surveillance 2018 - 2022 (NOSOGRIPPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03413228
Recruitment Status : Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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


Condition or disease Intervention/treatment
Hospital-Acquired Infection Influenza Other: Questionnaire

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France.
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Influenza-like illness group Other: Questionnaire
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples Without DNA
nasal swab

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-Everyone who does not present the inclusion criteria.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413228


Contacts
Layout table for location contacts
Contact: Philippe VANHEMS, MD PhD 0472110719 ext +33 philippe.vanhems@chu-lyon.fr

Locations
Layout table for location information
France
Infection Control unit. Edouard Herriot hospital Lyon - France
Lyon, France, 69003
Contact: Philippe VANHEMS, MD PhD    0472110719 ext +33    philippe.vanhems@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03413228    
Other Study ID Numbers: 69HCL17_0868
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases