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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03884777
Other study ID # CIC1429
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2009
Est. completion date December 31, 2017

Study information

Verified date December 2017
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

References & Publications (4)

Friman G, Schiller HH, Schwartz M. Distubed neuromuscular transmission in viral infections. Scand J Infect Dis. 1977;9(2):99-103. — View Citation

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. — View Citation

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. — View Citation

Tackenberg B, Schneider M, Blaes F, Eienbröker C, Schade-Brittinger C, Wellek A, Deschauer M, Eickmann M, Klenk HD, Müller HH, Sommer N. Acetylcholine Receptor Antibody Titers and Clinical Course after Influenza Vaccination in Patients with Myasthenia Gra — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of influenza in myasthenic patient in crisis Number of influenza cases in myasthenic patients between January 1, 2009 and December 31, 2017.
Secondary Risk factors for poor outcomes To identify risk factors for severe influenza in myasthenic patients between January 1, 2009 and December 31, 2017.
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