Incidence and Risk of Influenza in Myasthenic Patients | NCT03884777

Studies
Incidence and Risk of Influenza in Myasthenic Patients

NCT03884777

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Last Update Posted

Mar 21, 2019Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Myasthenic Crisis
Upper Respiratory Infection

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2009Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jan 16, 2019

First Submission Date that Met QC Criteria

Mar 20, 2019

First Posted Date

Mar 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2019

Last Update Posted Date

Mar 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of influenza in myasthenic patient in crisis	Number of influenza cases in myasthenic patients	between January 1, 2009 and December 31, 2017.

Secondary Outcomes

Measure	Description	Time Frame
Risk factors for poor outcomes	To identify risk factors for severe influenza in myasthenic patients	between January 1, 2009 and December 31, 2017.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Rania BOUNAB, Dr	Raymond Poincaré Hospital	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29109554	Result	Petrova VN, Russell CA. The evolution of seasonal influenza viruses. Nat Rev Microbiol. 2018 Jan;16(1):60. doi: 10.1038/nrmicro.2017.146. Epub 2017 Nov 7.
29337134	Result	Tackenberg B, Schneider M, Blaes F, Eienbroker C, Schade-Brittinger C, Wellek A, Deschauer M, Eickmann M, Klenk HD, Muller HH, Sommer N. Acetylcholine Receptor Antibody Titers and Clinical Course after Influenza Vaccination in Patients with Myasthenia Gravis: A Double-Blind Randomized Controlled Trial (ProPATIent-Trial). EBioMedicine. 2018 Feb;28:143-150. doi: 10.1016/j.ebiom.2018.01.007. Epub 2018 Jan 10.

ID	Term
D012141	Respiratory Tract Infections
D009157	Myasthenia Gravis
D009468	Neuromuscular Diseases

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms