NCT03884777

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
Last Updated

March 21, 2019

Status Verified

December 1, 2017

Enrollment Period

9 years

First QC Date

January 16, 2019

Last Update Submit

March 20, 2019

Conditions

Keywords

Influenza A virusmyasthenia gravisneurocritical care clinicalneuromuscular disease

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Risk factors for poor outcomes

    between January 1, 2009 and December 31, 2017.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Age \<18 years,
  • Other neuromuscular diseases,
  • Patient opposing the use of his data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • 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.

  • Friman G, Schiller HH, Schwartz M. Distubed neuromuscular transmission in viral infections. Scand J Infect Dis. 1977;9(2):99-103. doi: 10.3109/inf.1977.9.issue-2.08.

  • Rosciszewska D, Bluszcz M, Kurek H. [Antibodies for DNA and RNA viruses in the serum of myasthenia patients. Preliminary report]. Neurol Neurochir Pol. 1981 Sep-Dec;15(5-6):541-4. Polish.

MeSH Terms

Conditions

Respiratory Tract InfectionsMyasthenia GravisNeuromuscular Diseases

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesParaneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rania BOUNAB, Dr

    Raymond Poincaré Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2019

First Posted

March 21, 2019

Study Start

January 1, 2009

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

March 21, 2019

Record last verified: 2017-12