Myasthenic CrisisNCT03884777
Incidence and Risk of Influenza in Myasthenic Patients
An observational study of Myasthenic Crisis and Upper Respiratory Infection, run by Centre d'Investigation Clinique et Technologique 805.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenic Crisis, Upper Respiratory Infection
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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.
Who may be able to join
- Men or women over the age of 18.
- Myasthenic patients hospitalized in intensive care.
- Patients with confirmed influenza infection
Who cannot join
- Age <18 years,
- Other neuromuscular diseases,
- Patient opposing the use of his data
About this study
Official title: Incidence and Risk of Influenza in Myasthenic Patients Hospitalized in Intensive Care
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.
- Conditions
- Myasthenic Crisis, Upper Respiratory Infection
- Keywords
- Influenza A virus, myasthenia gravis, neurocritical care clinical, neuromuscular disease
- Medical subject headings
- Respiratory Tract Infections, Myasthenia Gravis, Neuromuscular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of influenza in myasthenic patient in crisis
Number of influenza cases in myasthenic patients
Measured: 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
Measured: between January 1, 2009 and December 31, 2017.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Jan 2009
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myasthenic CrisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rania BOUNAB, Dr, Study director, Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884777
- Sponsor's protocol ID
- CIC1429
- Status last verified
- Dec 2017
- First submitted
- 16 Jan 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 29109554Tackenberg 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 29337134Friman 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 197596Rosciszewska 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk of Influenza in Myasthenic Patients Hospitalized in Intensive Care
- ClinicalTrials.gov ID
- NCT03884777
- Acronym / sponsor ID
- CIC1429
- Conditions
- Myasthenic Crisis, Upper Respiratory Infection
- Keywords
- Influenza A virus, myasthenia gravis, neurocritical care clinical, neuromuscular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- Men or women over the age of 18.
- Myasthenic patients hospitalized in intensive care.
- Patients with confirmed influenza infection
Key exclusion criteria (3 listed)
- Age <18 years,
- Other neuromuscular diseases,
- Patient opposing the use of his data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Risk factors for poor outcomes
Time frame: between January 1, 2009 and December 31, 2017.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Results publication: PubMed 29109554Petrova 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.
- Results publication: PubMed 29337134Tackenberg 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.
- Results publication: PubMed 197596Friman 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.
- Results publication: PubMed 6281675Rosciszewska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania BOUNAB, Dr study director
Raymond Poincaré Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenic Crisis and Upper Respiratory Infection, run by Centre d'Investigation Clinique et Technologique 805.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of influenza in myasthenic patient in crisis (time frame: between January 1, 2009 and December 31, 2017.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884777, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.