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CompletedNCT03884777Updated Mar 21, 2019

Incidence and Risk of Influenza in Myasthenic Patients

An observational study in Myasthenic Crisis and Upper Respiratory Infection, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myasthenic Crisis
  • Upper Respiratory Infection

Keywords

  • Influenza A virus
  • myasthenia gravis
  • neurocritical care clinical
  • neuromuscular disease
03

In context

Respiratory Tract Infections

1,052 studies on the registry are indexed under Respiratory Tract Infections; 147 are open to participants now.

This study's enrollment of 400 is above the median of 300 across 299 observational studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 75 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of influenza in myasthenic patient in crisis

    Number of influenza cases in myasthenic patients

    Time frame: between January 1, 2009 and December 31, 2017.

Secondary outcomes

  1. Risk factors for poor outcomes

    To identify risk factors for severe influenza in myasthenic patients

    Time frame: between January 1, 2009 and December 31, 2017.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29109554 ↗
  • 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. PubMed 29337134 ↗
  • 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. PubMed 197596 ↗
  • 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. PubMed 6281675 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2009 to primary completion in Dec 2017, 107 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2019
First posted
Mar 21, 2019
StartActual
Jan 1, 2009
Primary completionActual
Dec 31, 2017
CompletionActual
Dec 31, 2017
Last update
Mar 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03884777
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible party
Sponsor
First posted
Mar 21, 2019
Start date
Jan 1, 2009
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Mar 21, 2019

Study contacts

Rania BOUNAB, Dr
study director · Raymond Poincaré Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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