Prospective Stratification of Infectious Risks in Multiple Sclerosis

Study Overview
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Brief Summary
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This monocentric study is to identify factors that increase the susceptibility for infections and establish a questionnaire-based infection score that allows a prospective stratification for infectious risks in patients with multiple sclerosis (MS) (InRIMS-Study). The study will utilize a validated, MS-adapted questionnaire and infection diary from the Airway Infection Susceptibility (AWIS) study in a regularly followed, prospective cohort of MS patients. It is a nested project of the prospective observational Swiss MS Cohort (SMSC) and SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies.

Official Title
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Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS-Study)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: MS-adapted AWIS questionnaire (MS-AWIS)
* Other: infection diary (MS-AWIS diary)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form (ICF) for the InRIMS-study and Swiss MS Cohort (SMSC) and/or Serially Unified Multicenter Multiple Sclerosis Investigation (SUMMIT) study Exclusion Criteria: Not able to sufficiently understand the patient information and questionnaire (German language) MS Patients with long-term antibiotic prophylaxis MS Patients with known primary immunodeficiency, under chemotherapy due to any malignancy or HIV infection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: MS-adapted AWIS questionnaire (MS-AWIS)|The predefined questionnaire-based infection score of the Airway Infection Susceptibility (AWIS) study is predictive for the occurrence of respiratory tract infections (RTI). In addition several MS-specific items (e.g. bladder dysfunction and urinary tract infections) are included into the AWIS questionnaire (MS-AWIS).|
|Other: infection diary (MS-AWIS diary)|MS patients prospectively fill out monthly infection diaries for 24 months. Infection diaries will either be sent back (with pre-franked envelopes) or handed back to the InRIMS-study team during regular clinical visits (usually every 6 or 12 months).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AWIS RTI score | AWIS RTI score is based on the data collected with the MS-adapted AWIS (MS-AWIS) questionnaire; score varies between 0 (no RTI burden) and 50 (maximal RTI burden) | Baseline | 
| infection diary score | monthly diary RTI score, averaging ten RTI symptom categories with the coding 0 for no infection reported, 1 for reported infection with duration < 2 weeks, and 2 for reported infection present with duration >2 weeks | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs | Comparison of infection scores between patients receiving DMTs and those who do not receive DMTs | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary immunodeficiencies, disease-modifying treatments (DMT), immunosuppressive therapy, serious infection, respiratory tract infections (RTI), urinary tract infections, infection diary, Swiss MS Cohort (SMSC), SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies