Multiple Sclerosis
Conditions
Keywords
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
Brief summary
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.
Interventions
OTHERMS-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).
OTHERinfection 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).
Sponsors
Swiss Multiple Sclerosis Society
Bangerter-Rhyner Stiftung
Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AWIS RTI score | Baseline | 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) |
| infection diary score | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs | 24 months | Comparison of infection scores between patients receiving DMTs and those who do not receive DMTs |
Countries
Switzerland
Outcome results
None listed