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Incidence and Risk of Influenza in Myasthenic Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884777
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Study Description
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Brief Summary:

Upper respiratory infection , including influenza, may exacerbate the symptoms of myasthenia gravis (MG), which is an autoimmune disease that causes muscle weakness and, in some cases, can precipitate a myasthenic crisis

In the present study, we investigated the incidence and risk factors of influenza infection on in myasthenia gravis patients.


Condition or disease
Myasthenic Crisis Upper Respiratory Infection

Detailed Description:

This is a descriptive study. The data will be analyzed retrospectively . Inclusion of 416 cases of influenza in myasthenic patients treated in the intensive care unit of Garches Hospital between January 1, 2009 and December 31, 2017.

Patients who meet the inclusion and non inclusion criteria and do not object to participate in the study will be collected in a database for analysis.

Study Design
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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence and Risk of Influenza in Myasthenic Patients Hospitalized in Intensive Care
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of influenza in myasthenic patient in crisis [ Time Frame: between January 1, 2009 and December 31, 2017. ]
    Number of influenza cases in myasthenic patients


Secondary Outcome Measures :
  1. Risk factors for poor outcomes [ Time Frame: between January 1, 2009 and December 31, 2017. ]
    To identify risk factors for severe influenza in myasthenic patients


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Inclusion of 416 cases of myasthenic patients treated in the intensive care unit of Garches Hospital between January 1, 2009 and December 31, 2017.
Criteria

Inclusion Criteria:

  • Men or women over the age of 18.
  • Myasthenic patients hospitalized in intensive care.
  • Patients with confirmed influenza infection

Exclusion Criteria:

  • Age <18 years,
  • Other neuromuscular diseases,
  • Patient opposing the use of his data
Contacts and Locations
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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): NCT03884777


Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Study Director: Rania BOUNAB, Dr Raymond Poincaré Hospital
More Information
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Publications of Results:

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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03884777    
Other Study ID Numbers: CIC1429
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Influenza A virus
myasthenia gravis
neurocritical care clinical
neuromuscular disease
Additional relevant MeSH terms:
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Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Infection